US catches up with Europe on biosimilar patents
Europe’s more liberal approach to patents on biosimilar drugs continues to give it an advantage over the United States in the production of lower-cost drugs, despite measures taken by Washington to facilitate market access for generic manufacturers.
Health care costs in the United States are significantly higher than those in Europe – the $ 11,000 spent per American in 2019 is more than double the amount per capita in France – with greater availability in Europe of medicines cheaper generics, or biosimilars, a contributing factor.
Biosimilars are generic versions of biologic drugs that can only be sold after a period of exclusivity for the creator of the original treatment. This time-limited monopoly on the drug allows pharmaceutical companies to recoup the money spent on research and development (R&D).
“Without such protections, pharmaceuticals would not be able to profit from their work,” says Eileen Cole, partner at White & Case, a US law firm. “These exclusives aim to encourage pharmaceutical companies to innovate.
“Other manufacturers are able to develop their own treatments that are biologically similar. These biosimilars must then be registered and approved by regulators before they can enter the market and compete with the original treatment, ”she explains.
In Europe, the European Medicines Agency (EMA) will not approve a biosimilar for the first 10 years after the approval of the original medicine. But, in the United States, the Food and Drug Administration (FDA) will wait 12 years.
This difference in timing can be seen in the case of the drug bevacizumab – a treatment for colon and lung cancer and renal cell carcinoma, sold under the name Avastin. This year, Europe approved a fifth biosimilar for Avastin, while the United States approved only two biosimilars for bevacizumab in total, in 2017 and 2019.
As a result, the EMA has now cleared at least seven biosimilars of all types this year, while the FDA has approved none, notes Washington-based Aydin Harston, intellectual property attorney at Rothwell, Figg, Ernst & Manbeck. , an American law firm. .
And this matters to pharmaceutical companies, because the introduction of biosimilars can lower the price of drugs. For example, they have cut the cost of some blood clot treatments in Europe by two-thirds, according to data provider Iqvia.
“It’s a market that the drug companies inventing such treatments are watching closely,” says Harston, who also has a doctorate in biochemistry. “Global sales of the top 10 brand-name biologics totaled approximately $ 81 billion in 2019.”
The reluctance of the FDA to keep pace with Europe can be attributed to its rigorous review process for biosimilar approval, suggests Harston, but also to the heavy lobbying presence of the pharmaceutical industry in Washington.
Pharmaceuticals and healthcare companies spent $ 306 million lobbying government in 2020 – the most of any industry, according to research firm Statista.
“There is a direct cost to the public in the availability of biosimilars to brand-name treatments – the more biosimilars there are, the more generic drug options are available at a lower cost,” Harston points out.
“But there is a balance to be found,” he continues. “Intellectual property protections exist to spur innovation and, without them, pharmaceutical companies would generally not have sufficient motivation to develop new treatments, especially expensive biologic therapies. “
Such innovation from drugmakers has been in the spotlight in the race to develop vaccines during the Covid-19 pandemic, Cole notes.
“Pharmaceutical companies that had implemented techniques based on their R&D were able to quickly turn around and focus on the problem at hand,” explains Cole. “If we hadn’t already had large pharmaceutical companies innovating in these spaces, developing a Covid vaccine would probably have taken a lot longer. “
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Still, the United States appears to be loosening its grip on biosimilar approvals.
In April, US President Joe Biden signed two bipartisan bills aimed at lowering prescription drug prices by supporting biosimilar alternatives to brand name drugs.
Iqvia estimates that expanding the use of biosimilars could reduce drug costs in the United States by $ 100 billion over five years.
In particular, the Advanced Education on Biosimilars Act has pledged funds to educate patients, doctors and caregivers about biosimilar drugs through a new government website.
Activating this wider access to biosimilars enjoys bipartisan support on Capitol Hill, where – in total – three bills are now circulating to expand access to generics.
“The pandemic has forced us all to learn more about the pathways of medicine and drug development – how long can treatments take to develop and the importance of innovation,” Cole said. “The government has taken note of the need to educate people.”