Biosimilars go 2-0 in an FDA double-header favoring Novartis, Amgen

Now that the FDA advisory committee brought together on biosimilars has had a chance to brush up on the agency’s regulatory framework and objectives, the outside experts had little trouble reaching for another unanimous decision endorsing Novartis’s copycat of Enbrel.

The vote was 20-0 in favor, reflecting the agency’s insider opinion that Novartis—which scored the first approval for a biosimilar in the U.S. and has a whole lineup being prepped for an OK—has perfected the development process. Coming swiftly on the heels of another bright green light yesterday for Amgen’s biosimilar of AbbVie’s $14 billion franchise drug Humira, there’s considerably less mystery about what manufacturers need to do to win approvals in this new but fast growing field.

Monday’s vote marked progress for Amgen in its quest to field the first of several knockoffs aimed at Humira. But ironically the same company was on defense Tuesday as it sought to guard against a competitor that will likely be approved for all indications now allowed Enbrel, a $9 billion gold mine for Amgen and its partners.

There’s been a lot of public opposition to extrapolation—taking data on one disease and applying it for all the conditions which the original developer had to win one at a time. The key is the similarity of the drugs. Once the biosimilar manufacturer has pegged that with convincing late-stage data, the rest falls into place—at least among these original players. And fighting extrapolation appears to be a losing strategy for anyone playing defense.

Far less certain, though, are the intense rear guard fights that companies are waging in the courts. AbbVie has plans to delay any direct competitor to Humira for years, and others are taking the same legal approach, ready to make virtually any argument to prevent a lower priced drug from reaching the marketplace.

Nevertheless, you can be sure that everyone playing in this space, a group of multinationals that includes Pfizer, Merck and Samsung, are paying close attention to every word spoken over the past 48 hours. The first new entry among biosimilars is unlikely to cut the initial price much. These older drugs have been priced steadily higher in the lead up to the loss of patent protection, leaving the pioneers in search of a blockbuster market share. But as more biosimilars for the same product pile in, that price is expected to fall steadily.

Now the industry will wait, perhaps for some time, to see if Novartis CEO Joe Jimenez is right, and that the price of these new drugs will eventually slash the wholesale price as much as 75%.

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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Director Process Development
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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