Two for two: FDA panel gives green light to Novartis' Enbrel biosim
- In its second review this week, an advisory panel to the Food and Drug Administration unanimously voted to support the approval of Novartis' biosimilar copy of Amgen’s Enbrel, Novartis announced Wednesday.
- Novartis mainly presented data from clinical trials of the biosimilar in patients with plaque psoriasis, but if the FDA gives it the green light, the drug will also be approved for all of Enbrel’s indications. The FDA usually follows the advice of its advisory panels, but is not obliged to do so.
- Enbrel is one of the core TNF-alpha inhibitors used to treat inflammatory conditions like rheumatoid arthritis. Last year, Enbrel generated roughly $5.4 billion in revenues for Amgen, or 25% of the company’s total sales.
For the second time this week, a biosimilar has won the backing of the FDA's arthritis advisory panel. The committee on Tuesday gave a green light to Amgen's Humira biosim and followed that up with a positive recommendation for Novartis' candidate.
Both decisions show a willingness to accept clinical trials in one indication with scientific justification for extrapolation to others as a sufficient foundation to support biosimilarity.
Advocates for biosimilars contend the trend is moving in the right direction. The Generic Pharmaceutical Association released a statement on Tuesday urging FDA recommendation of the two biosimilars.
"The Biosimilars Council commends the FDA’s work toward creating a regulatory environment that maximizes patient access to biosimilars," said Christine Simmon, vice president at GPhA and executive director of the Biosimilars Council.
GPhA is not in favor, however, of requiring a statement of biosimilarity on the drug's eventual product label.
"Including a biosimilar product’s biosimilarity data in addition to that of the reference product would only provide unnecessary information and create confusion for prescribers and patients," GPhA said.
Even if Amgen's and Novartis' biosimilars are approved, they will likely not reach the market for some time due to patent litigation. Both AbbVie and Amgen are intent on defending their patents, with the goal of delaying market entry of copycat versions of their drugs for as long as possible.