September 2021

Generic drugs

FDA Guidelines Cover Commonly Asked Questions from CMC for Generic Drugs

Posted on September 21, 2021 | Through Joanne S. Eglovitch

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday released draft guidelines that provide generic drug applicants with answers to frequently asked questions in the area of ​​drug quality. medications. The new guidelines are designed to provide an immediate response to these questions to reduce the number of controlled matches on identical topics.

The guidelines, which are in the form of questions and answers, cover FDA policies on quality-related scientific and regulatory topics that “appear frequently” in vetted correspondence submissions from CDER’s Office of Pharmaceutical Quality. The intent of the guidelines is to help industry “move forward with certain generic drug development activities without the need to submit controlled correspondence to the FDA,” according to an email from the agency. September 20.

Under the Generic Drug User Fee (GDUFA II) changes, manufacturers who submit a question through the controlled match mechanism may wait up to 60 or 120 calendar days for a response, depending on the type of controlled correspondence, as the agency reiterated in its final version. guidance released last December (RELATED: Generics: FDA Finalizes Controlled Match Guidance, Regulatory guidance December 17, 2020).

The nine questions and answers contained in the guidelines to date are “derived from numerous vetted match submissions” and cover parenthesizing and mastering expectations, container closure changes, dissolution, testing for endotoxins, the number of lots of exhibits needed and the scoring and testing of split tablets. .

Some of these frequently asked questions and the answers from the FDA are as follows:

Bracketing and mastering

The FDA has clarified that a bracketing approach is acceptable for a multi-strength drug product, as long as the active and inactive ingredients are proportional to the dose.

The agency was responding to a question about whether it is acceptable to use a bracketing approach for manufacturing voucher lots of a generic drug with multiple strengths produced from granulations or bulk blends currents, and whether all of these batches should be placed on a stability program.

The guidelines specify that sponsors should produce three separate intermediate bulk batches, with one batch representing all proposed concentrations, one batch reflecting the lowest concentration, and one batch reflecting the highest concentration. For more information, sponsors should consult the May 2014 FDA guidance titled “ANDA: questions and answers on stability testing of drug substances and products.”

Container closing systems

A proposed generic drug need not have the same container closure system (CCS) as the reference product, the agency said in response to a question about whether a generic drug could be packaged in a bottle if the RLD is packaged in an ampoule.

Still, the application “must contain information to show that the proposed generic drug has the same terms of use and labeling, with certain permitted differences, as the RLD.”

Bacterial endotoxins

The guide provides answers to two questions related to bacterial endotoxins. The first answer relates to how an acceptance criterion for endotoxin testing should be determined for a finished pharmaceutical product. Here, the FDA directs generic developers to General Chapter 85 of the American Pharmacopoeiawhich defines the maximum endotoxin exposure for drugs in general and for topical and intrathecal drugs.

Topical ophthalmic drug products do not have to be tested for bacterial endotoxins, the FDA said, answering a second question about whether it is acceptable to omit bacterial test limits for these products. However, endotoxin testing may be required if the product is to be used on an abraded eye or used during surgery.

The FDA has advised industry to consider these matters before submitting controlled correspondence on these topics. The agency intends to add additional questions and answers as needed to address any frequently asked questions that may arise.

FDA Guidelines on Controlled Correspondence

© 2022 Society of Regulatory Affairs Professionals.

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Medical products

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Generic drugs

The generic drug market is witnessing the emergence of Amgen Inc. and Dr. Reddys Laboratories Ltd. as major market contributors | 17000 + Technavio

Understand the driving forces of the Generic Drugs market and target potential customers here.

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Analysis of the main players in the market

  • Amgen Inc. – The company offers a wide range of generic drugs like Aimovig, Corlanor, Epogen, Xgeva and others.
  • Dr.Reddys Laboratories Ltd. – The company offers affordable generic formulations such as Omez (Omeprazole), Nise (Nimesulide), Ketorol (Ketorolac Thromethamine) and others
  • Fresenius SE and Co. KGaA – The company offers generic drugs for areas such as anesthesia, maldigestion and oncology

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Generic Drugs Market 2021-2025: Segmentation

The generic drugs market is segmented as follows:

  • Type
    • Small Molecule Generics
    • Biosimilars
  • Geography
    • North America
    • Europe
    • Asia
    • LINE

The generic drug market is driven by increased outsourcing of drug discovery and development and increasing drug patent expirations. Additionally, other factors such as the advent of RPA, increase in mergers and acquisitions, and hospital-owned generics are expected to drive the generic drugs market.

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Generic drugs

Online pharmacies could save Medicare billions on generic drugs

PThe public outcry over the shockingly high cost of brand name drugs and the demand for new laws to limit the cost of these drugs has persisted for years. But more than 90% of all prescriptions – nearly 4 billion a year – are filled with generic drugs.

Little attention has been paid to the fees charged by insurance companies, drug benefit managers, and pharmacies to fill these generic prescriptions. Yet the difference between the highest and lowest price charged for the same generic drug is so great that billions of dollars could be saved each year by having prescriptions filled at the cheapest pharmacies.

The entry of companies like Amazon and GoodRx into the prescription fulfillment business is a game-changer. They offer prices far below what the federal government pays to insurance plans to have these prescriptions filled under Medicare Part D drug coverage. The repeal of the current design of Part D benefits and replacing it with a system in which the government directly reimburses low-cost pharmacies for filling generic prescriptions would save an estimated $18 billion a year. Patients would save an additional $8 billion in co-payments because the prices charged by these pharmacies do not require any form of insurance or additional co-payments.


I compiled information from the Medicare Part D website on the amount spent per pill for the top 20 selling generic drugs of 2019. I then determined how much Amazon and GoodRx charged for a 90 day prescription for the same 20 medications and calculated the cost per pill for these prescriptions. For example, Medicare paid 26 cents per pill for atorvastatin, the generic version of the cholesterol-lowering drug Lipitor. Amazon fills a 90-day prescription for a 20-milligram atorvastatin tablet, the most common dose, for $4.20. This equates to less than 5 cents per pill. The government paid $919 million to insurance plans to distribute 3.6 billion atorvastatin tablets in 2019. Amazon reportedly distributed these tablets for $182 million, a savings of $737 million on a single drug generic.

As the chart here shows, Medicare spent $8.8 billion to distribute these 20 generic drugs in 2019. Amazon reportedly did this for just $4.6 billion and GoodRx for $5.1 billion. If the prescriptions had been filled by selecting the cheapest drug from Amazon or GoodRx, the cost would have been $3.5 billion. This represents a savings of $5.3 billion (60%) over what Medicare spent.


In 2019, Medicare Part D filled approximately 1.2 billion generic prescriptions at a total cost of approximately $30 billion. If the 60% savings applied to all generic drugs dispensed under Part D, the government would have saved $18 billion.

In addition to overburdening the government, Part D insurance plans also charge patients co-payments for most generic prescriptions. Iqvia reports that 65% ($8 billion) of the $12 billion in Part D outlays paid by patients are for generic prescriptions. GoodRx estimates that its total price for filling generic prescriptions is less than the Medicare Part D copay about one-third of the time. The Amazon and GoodRx price is the total price of the drug. There is no quota. That means patients would save $8 billion in out-of-pocket costs, bringing the total savings from a Medicare drug benefit overhaul to $26 billion.

How is it possible that the cost of filling generic prescriptions can vary so widely? The answer lies in a lack of transparency on the true cost of generic drugs. The World Health Organization estimates that generic versions of essential medicines can be produced cost-effectively with a 99% reduction in the cost of the brand name medicine. Thus, a patented pill that sells for $1 can be produced profitably and sold as a generic for a penny. In fact, generic manufacturers now sell many of the most widely prescribed generic drugs in the United States for 1 cent to 5 cents per pill.

Competition among generic manufacturers ensures that these pills are offered for sale at a small profit compared to the actual cost of producing them. Yet in a few cases where such competition is lacking, as was the case with the generic version of the EpiPen, the cost of a generic drug may sell for only a small discount to the brand name product.

Insurance plans and drug benefit managers price their generic prescriptions at levels that the market will bear rather than at a reasonable markup over the actual cost of acquiring and dispensing the prescription. Patients and payers think they’re getting a good deal when they get a 70% discount and pay 30 cents per pill for the generic version of a brand name drug they used to pay $1 for. They have no idea that the pharmacy bought this pill for just a penny or two and markup each pill 10 to 20 times its cost. The high markup imposed by insurance plans and drug benefit managers is why the government pays 26 cents a pill for atorvastatin while Amazon sells it for 5 cents.

Discount pharmacies like Amazon disrupt the prescription drug market by pricing their prescriptions on a cost-plus basis while making a fair profit. A 90-day prescription for a generic drug acquired at a cost of 1 cent per pill has an ingredient cost of 90 cents. Average dispensing cost – the cost to the pharmacy for time spent counting and packaging pills, labeling pills, complying with prescription record keeping laws, and recording information required for reimbursement insurance plans – is about $2.40 per prescription. If a discount pharmacy charges $5.00 for this 90-day prescription, they will make a profit of $1.70 on the actual $3.30 cost of the prescription. This equates to a gross profit of 34%, which compares favorably to the reported profit margins of independent pharmacies.

For a 90 day prescription, adding ten cents to the cost of each pill would add $9 to the cost of the prescription. That doesn’t sound like a lot, but doing this for 4 billion prescriptions translates to $36 billion.

Medicare should be able to fill generic prescriptions at the lowest price charged for those prescriptions in the competitive retail market. But the 2003 law that created Part D prohibits the government from seeking the best price and gives private insurance plans exclusive power to set the price. The Republican administration that championed the enactment of Part D mistakenly believed that competition among insurance plans would result in the lowest prices and the widest choices for beneficiaries. No such competition ever materialized. Instead, Part D has created windfall profits for private insurance plans and drug benefit managers while adding unnecessary complexity to the generic prescription filling process. Patients are now faced with an incomprehensible array of forms, quantity limitations and co-payments that often make it cheaper to pay for a generic drug outright than to use Part D insurance.

The current design of the Part D advantage is ill-suited to a world in which discount pharmacies fill prescriptions for generic drugs at affordable prices without insurance. A new design that cuts out costly middlemen and relies on price competition between pharmacies will not only dramatically reduce Part D costs, but will also force all pharmacies to cut their profit margins if they hope to compete for prescriptions of part D, which represent 30% of retail pharmacy activity.

Part D prices for generic drugs would quickly become the benchmark for private payers and drive down prices and copayments for generic drug prescriptions in private insurance plans. The end result would be that more than 90% of all prescriptions could be filled at a lower cost to payers without imposing significant additional costs on patients.

Senate Democrats are currently negotiating a $3.5 trillion soft infrastructure package that will include legislation to reduce patient out-of-pocket payments in Part D and expand Medicare to cover vision, dental and hearing services by mandating new taxes. My proposal to reduce the cost of Medicare for the distribution of generic drugs and the Biden administration’s proposal to limit price increases for brand name drugs could produce enough savings on the cost of current Medicare benefits for drugs on prescription to pay for the proposed expansion of Medicare benefits without these taxes.

Given growing resistance from moderate Democrats to the $3.5 trillion price tag of the proposed infrastructure package, paying for new benefits by reducing the cost of existing ones may be the wisest course.

Alfred Engelberg is a retired intellectual property lawyer and philanthropist who focuses on efforts to make health care and medicine more affordable. As legal counsel to the generic drug industry, he played a major role in drafting the Hatch-Waxman Act of 1984, which created the modern generic drug industry.

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Medical products

PRIMED Medical Products donates over 1.5 million Level 3 surgical masks to Lao PDR to continue the global fight against COVID-19

Edmonton, Alberta–(Newsfile Corp. – Sept. 8, 2021) – In a ceremony on Aug. 18, Lao PDR received a shipment of 1,592,500 ASTM Level 3 surgical masks donated by PRIMED Medical Products, in partnership with the Government of Canada in Laos. This shipment of masks was handed over to the government of the Lao PDR during a ceremony attended by the Minister of Health, Dr. Bounphaeng Phoummalaisit, Mr. Bob Paquin, Charge d’Affaires and Head of Office, Office of the Canadian Embassy in Laos, Mr. Leo Xie, PRIMED Deputy General Manager for Asia Manufacturing, and Ms. Peng Jin and Ms. Yu Hsuan Pi of VITA Park at the Ministry of Health Headquarters in Vientiane.

The masks donated are the same highly protective masks that many of those working on the front lines of COVID-19 in Canada and around the world rely on. The masks will be used by healthcare providers as Laos faces its second wave of the pandemic. Throughout the COVID-19 pandemic, PRIMED has been focused and successful in ensuring a consistent and safe supply of PPE to all of its global partners.

“Canada is a nation that gives back when the world is in need,” said David Welsh, President and CEO of PRIMED Medical Products. “We felt it was imperative to do our part to help protect the local community members who have welcomed us with open arms as we expand our manufacturing facility in Laos.”

“PRIMED is a Canadian company with a strong commitment to corporate social responsibility, and is keen to support the Government of Laos’ campaign to promote quality investment,” said Bob Paquin, Chargé d’Affaires, Office of the Embassy of Canada in Laos.

PRIMED recently completed the construction of the first phase of its factory in Laos. The wholly-owned facility measures 95,000 square feet and, at full capacity, will employ more than 300 people. This donation brings PRIMED’s total surgical mask donations during the pandemic to nearly 40 million masks.

About PRIMED medical products

Founded in 1995, PRIMED Medical Products is a Canadian manufacturer of personal protective medical equipment. PRIMED’s manufacturing facilities are ISO certified and undergo regular audits by international regulatory and certification bodies. PRIMED’s high-quality medical products are used in virtually every hospital in Canada and in healthcare facilities in the United States, South America, Europe, Asia, South Africa, Australia and New Zealand. Zeeland. Their product offering covers medical, surgical, and infection control products, including protective apparel and wound care.

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Medical products

Baxter acquires Hillrom in $10.5 billion medical products deal

DEERFIELD, Ill. (AP) — Medical products company Baxter International will acquire medical technology company Hillrom for $10.5 billion in cash, the companies announced Thursday. Baxter will also absorb Hillrom’s debt and cash, bringing the total value of the deal to $12.4 billion.

Baxter will pay Hillrom shareholders $156 per share, a 26% premium to its closing price on July 27, when speculation of a deal began to spread. Hillrom shares closed at $145.06 on Thursday and rose more than 3% in premarket trading to $149.75.

Deerfield, Ill.-based Baxter, which offers essential hospital products including dialysis, IV fluids and other therapies and devices, had 2020 revenue of $11.7 billion, with projected sales of $12.6 billion this year.

Hillrom, headquartered in Chicago, focuses on medical technology products and services such as smart beds, patient monitoring and diagnostic technologies, and advanced surgical equipment. Its turnover is close to 3 billion dollars per year.

The deal has been agreed by the boards of both companies and is expected to close in early 2022, pending regulatory approval and a vote from Hillrom shareholders.

Baxter shares rose about 1% in premarket trading to $78.40.

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Medical products

Baxter to Acquire Hillrom in $ 10.5 Billion Medicines Deal | Illinois News

DEERFIELD, Ill. (AP) – Medicines company Baxter International will acquire medical technology company Hillrom for $ 10.5 billion in cash, the companies said Thursday. Baxter will also absorb Hillrom’s debt and cash, bringing the total value of the transaction to $ 12.4 billion.

Baxter will pay Hillrom shareholders $ 156 per share a 26% premium over its July 27 closing price when speculation about a deal began to rise. Hillrom shares closed at $ 145.06 on Thursday and rose more than 3% in pre-market trading, to $ 149.75.

Baxter, based in Deerfield, Ill., Which offers essential hospital products including dialysis, intravenous fluids and other therapies and devices, had sales of $ 11.7 billion in 2020, with expected sales of $ 12.6 billion this year.

Hillrom, headquartered in Chicago, focuses on medical technology products and services such as smart beds, patient monitoring and diagnostic technologies, and advanced surgical equipment. Its turnover is approaching $ 3 billion per year.

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The deal was reached by the boards of directors of both companies and is expected to be finalized in early 2022, pending regulatory approval and a vote by Hillrom shareholders.

Baxter shares rose about 1% in pre-market trading, to $ 78.40.

Copyright 2021 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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Generic drugs

The size of the global generic drugs market worth USD 442.3 billion by 2026, according to market data forecast

Global Generic Drugs Market Size and CAGR (2021 to 2026)

According to our report, the global generic drugs market size was valued at USD 311.8 billion for 2021 and is projected to reach USD 442.3 billion by the end of 2026, growing at 7.24% CAGR during the forecast period.

Impact of COVID-19 on the global generic drugs market:

Generic and biosimilar drug companies are working tirelessly to ensure patients have access to the medicines they need as the COVID-19 outbreak progresses. Despite the global pharmaceutical supply chain under unprecedented stress and demand, producers of nine out of ten prescriptions filled with generics are driving demand for generics. The COVID-19 pandemic has hampered drug development in a variety of ways, including disrupting ingredient supply and delaying inspections of manufacturing facilities. As a result, during COVID-19, the United States Food and Drug Administration (FDA) issued guidance on generic drug development and the filing of abbreviated new drug applications (ANDAs), which outline how manufacturers can face the challenges of the pandemic. Additionally, the companies have come together under the not-for-profit Medicines Patent Pool (MPP). A group of 18 generic drug makers from India, China, Bangladesh and South Africa have pledged to work together to accelerate access to millions of doses of new COVID-19 treatments for low-income countries and intermediate. Nevertheless, questions regarding equity, overflow capacity, the social security system, data collection and drug supply, especially for generic drugs, have been raised by COVID-19. The majority of active pharmaceutical ingredients (APIs) are imported from other countries. For example, 80% of APIs used in drugs supplied to the United States come from China and India. Additionally, companies often employ a single plant to manufacture all of their supply, disrupting generic drug manufacturing.

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The growing prevalence of chronic diseases is fueling the demand for generic drugs.

The demand for generic drugs is increasing as chronic diseases become more prevalent. Furthermore, disease prevention is highly dependent on generic drugs. There has been a significant increase in the use of generic drugs for over three decades, and they account for 83% of all prescriptions filled. For chronic diseases such as diabetes, hypertension, osteoporosis, depression and anxiety, the study published in PLOS Medicine showed that more than 3.5 million people found equivalent clinical results in patients who started generics and branded drugs. For this reason, the use of generic drugs has increased, which has fueled the expansion of the generic drug market.

The expiration of patents on branded drugs is further fueling the generic drug market.

A generic drug is designed to be identical to an approved brand name drug in terms of dosage form, potency, method of administration, quality, and performance. Generic drugs are interchangeable with brand name drugs. When a brand name drug’s patent expires, the producer attempts to produce a generic drug. Several of its patents will expire in October 2021, possibly allowing generic copies to enter the market. Xgeva and Prolia from Amgen, Faslodex from AstraZeneca, Eraxis from Pfizer, Factive from LG Chem, Angeliq from Bayer and Bredinin from Chong Kun Dang are among the patents that will expire in January 2021. About 62 patents for more than 150 pharmaceutical products in South Korea will expire this year. , more than half of which are expected to be generics if no new patents are added to the patent list. As a result, the generic drug market is growing.


Market expansion is hampered by public perception of generic drugs. Because generics are inexpensive, they are considered substandard. In general, the notion that low price equals poor quality is widely held. Additionally, strict rules governing the safety and efficacy of generic drugs are hampering market expansion.

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  • According to gender, the generic drugs market is segmented into pure generic and branded drugs.
  • Depending on the application, the cardiovascular segment dominated the generic drug market in 2020 and accounted for a large market share in 2020. Rising cases of heart failure, hypertension, and stroke are driving the demand.
  • The North American region is a fast growing market for generic drugs. This is because, in the US region, most prescriptions are filled with generic drugs.
  • Major players in the generic drugs market are Mylan Inc., Sun Pharmaceutical Industries Ltd., Cipla Inc., Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., Lupine Ltd., Sanofi and others. Additionally, these players are involved in strategic activities, such as collaborations, new product launches, technological advancements, and acquisitions.

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Recent market developments:

  • In March 2021, Libbs Farmaceutica and Biocon teamed up to bring generic drugs to Brazil, the sixth most populous country in the world.
  • In March 2021, to improve its R&D engine and expand its generics and CDMO business, ANI Pharmaceuticals, Inc. purchased Novitium Pharma.
  • In January 2020, with the help of Civica Rx and 18 independent BCBS companies, the Blue Cross Blue Shield Association and BCBS companies were working together to reduce the cost of generic prescription drugs.


By type:

  • Pure generic drugs
  • Branded generic drugs

Per application:

  • The central nervous system (CNS)
  • Cardiovascular
  • Dermatology
  • Oncology
  • Respiratory
  • Others

By region:

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa


  1. Ranbaxy Laboratories, Ltd
  2. Actavis
  3. Mylan, Inc.
  4. industries, ltd.
  5. Reddy Laboratories
  6. By Pharmaceutical, Inc.
  7. Sandoz International GmbH
  8. Hospira, Inc.
  9. Apotex, Inc.
  10. Watson Pharmaceuticals, Ltd.
  11. Teva pharmaceutical


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Generic drugs

OP-ED: Americans deserve public generic drugs – Orange Leader

Bold policies could have saved America’s largest generic drug factory, but it’s never too late to start putting communities first.

It’s an all-too-familiar story. A company with some of the highest paying jobs and a vital community anchor decides to engage in “restructuring” to “maximize long-term value creation”.

In other words, it closes its doors and lays off its workers in search of bigger profits.

But the late July closure of the Viatris pharmaceutical plant in Morgantown, West Virginia – which employed nearly 1,500 people and was the largest remaining generic pharmaceutical plant in the United States – is particularly infuriating.

West Virginia Governor Jim Justice echoed a sentiment across the political spectrum when he said Aug. 4, “I think it’s pitiful, pitiful, absolutely pitiful that our federal government right now, with something as critical as pharmaceuticals are to our citizens, either just decide to sit on the sidelines and let this disaster happen.

The shutdown was only preventable – if there had been federal or state action based on prioritizing protecting public health and economic well-being over short-term shareholder returns. We had the tools. All that was needed was the audacity and the political will to use them.

The chain of events began in 2020 when factory owner Mylan (led by Heather Bresch, daughter of West Virginia Senator Joe Manchin) merged with Upjohn to form a new company, Viatris, creating the largest generics company in the world. Shortly after, Viatris announced a “restructuring initiative” which included closing some of its plants, including the Morgantown plant.

The local Steelworkers representing many workers at the plant began calling on both the new Biden administration and state officials to keep the plant open. Their key argument was its role in the country’s pharmaceutical supply chain, especially in the context of the COVID-19 pandemic. The plant produced 18 billion doses of low-cost generics a year, including many essential drugs paid for through various federal programs.

A letter to the Biden administration signed by the Steelworkers and about 40 other healthcare and advocacy groups (including The Democracy Collaborative, where I work) called for using the Defense Production Act to stop the plant shutdown .

One of President Biden’s first executive orders called for using the law if necessary to “acquire additional inventory, improve distribution systems, build market capacity, or expand the industrial base.” But the Biden administration, like the Trump administration before it, did none of that in Morgantown.

Keeping the Morgantown plant open would have been a clear case of ensuring local distribution and manufacturing capacity for a critical good: medicine. The designation the plant has already received from the Department of Homeland Security as critical infrastructure underscores this.

The opportunity to explore a public ownership option in pharmaceuticals has been overlooked. Public enterprises are free from profit constraints and can instead define their bottom line by what they contribute to public health, scientific advancement, and local economic resilience.

The payoffs for our communities would be enormous: Reliable access to affordable generics helps keep people out of hospitals and into jobs, schools and community service roles. Generics significantly reduce our overall health care costs. Additionally, manufacturing plants are vital economic engines as well as centers of local intellectual capital.

It is encouraging that a public institution, West Virginia University, announced talks with Viatris to acquire the plant, but that was after hundreds of highly skilled workers were unnecessarily laid off, most of whom are eager to see if an agreement is reached before looking for New work.

What we really need in the face of continued outsourcing and offshoring is a genuine industrial strategy that includes public ownership and puts community health above the demands of absentee shareholders.

Dana Brown is director of the Next System Project of The Democracy Collaborative, “a research and development laboratory for the democratic economy”. This editorial was distributed by

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Medical products

Advancing next-generation medical products

Photos courtesy of Avient Corporation, © 2021

An aging population and the growing threat of emerging infectious viral diseases, such as COVID-19, mean that global healthcare is an extremely important problem and is changing dramatically and dynamically. To respond to these changes, a new generation of specialized and sustainable medical equipment solutions is emerging. Read on to learn more about the evolution of this industry and to explore an example of medical device innovation.

If you haven’t seen a doctor in person since the onset of the coronavirus pandemic, you are not alone. Telemedicine and on-demand care have exploded over the past 12 months and are two of many growing trends in global healthcare. Another trend in the era of increasing personalized medicine is the development of biologic pharmaceuticals. A rapidly growing market, the revenues of biologic pharmaceutical companies have increased by 70% over the past five years, to more than US $ 232 billion.[i]. Yet the high doses required by patients for biologic therapies can present very real challenges for drug delivery.[ii]. Whatever the trend and in all directions in which healthcare develops, the goal is always to protect and improve the lives of patients.

Plastics in medical devices and pharmaceutical packaging increasingly play a vital role in providing safe treatments and their use is expected to increase further. This can be attributed to the fact that they offer design freedom, protection, convenience and functionality that few other materials can match. Globally in 2020, approximately 7.6 million tonnes of plastics were used in healthcare applications[iii] and this is expected to grow by around 8.6% from 2020 to 2027. Companies supplying plastics to the healthcare market must have in-depth knowledge of the industry, as well as advanced technical and design capabilities, to develop innovative solutions that truly respond to their customers. challenges.

Let’s take a look at an example of an innovative solution – a conceptual auto-injector, where the new generation meets industry trends for the functionality and aesthetics of surfaces.

Auto-injectors are a great example of innovation, bringing more convenience and control to the lives of patients. Playing on trends in telemedicine, on-demand care and biologics, they offer self-management and drug administration, technology-driven monitoring and diagnostics, as well as the ability to deliver increased volumes of drugs. and large molecule biologics.

This study example describes a conceptual auto-injector developed by Avient – a new materials company born from two historical leaders, PolyOne and Clariant Masterbatch. It will illustrate how Avient has used innovative materials, design and technological services to accelerate the development of next generation products.

Photos courtesy of Avient Corporation, © 2021

The injection window and cap of an autoinjector require excellent clarity, scratch resistance, and exceptional toughness for visualizing drug levels. In this study, an anti-UV additive was used to protect the drug contents from harmful UV rays without sacrificing clarity or transparency. Next, a dynamic masterbatch formulation (MEVOPUR ™ medical grade dyes) was used to enable product differentiation, better drug identification and consistent branding. MEVOPUR colors highlight the cap, button, lot ID / SKU, trigger and plunger. The raw materials were tested against common pharmaceutical standards to ensure that the devices would be safe and compliant from a regulatory point of view.

On the body of the autoinjector, a laser marking additive has been used to enable inkless marking, with no surface pretreatment required, thus avoiding solvent residue. The additive provided reliability and process improvement over traditional marking technologies and improved design possibilities due to the absence of physical contact with the marking system. This type of laser marking functionality can be combined with other functions or dyes to meet performance and aesthetic needs. In addition, to combat the increase in counterfeit drugs and devices in the healthcare industry, Avient has also developed a comprehensive plastic solution that protects against counterfeiting, while enabling medical device companies to ensure the integrity. supply chain with low impact on productivity and operations.

For the integrated rigid needle guard and device cap, biocompatibility, durability and overmolding are essential. A medical grade TPE (Versaflex ™ HC TPE) replaced rubber, with sealing properties to prevent needle contamination and oxygen contact with drugs in pre-filled syringes. These TPEs are USP VI tested and chemical resistant with low extractability and no tearing.

The viscosity of the drug has a direct impact on the pain of patients during drug administration. Therefore, the device’s heating system and heat exchanger used thermally conductive formulations to help heat and reduce the viscosity of biologic drugs.

Technology is transforming the way care is delivered by making it simpler, easier, more collaborative and more data-driven. This conceptual auto-injector is a demonstration of how next-generation materials and design expertise can truly improve a finished device.

If you would like more information on this application study, or on Avient materials and colorant / additive technologies, please visit


Content sponsored by Avient Corporation

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