Sandoz's Biosimilar Rejection Ups Risks, But Won't Kill Market
The FDA's rejection of Sandoz Inc.'s version of Amgen's Neulasta (pegfilgrastim) has revealed the hard truth that chasing the biosimilar market may be a riskier and more costly endeavor than companies anticipated.
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With the FDA giving an overwhelmingly positive review of Sandoz Inc.'s application for its biosimilar version of Enbrel (etanercept), which is sold in the US by Amgen Inc., the product appears to be headed to the US market – pending a likely blessing from the agency's advisory panel, which is meeting on July 13. But Sandoz must still get past litigation and convince prescribers and patients its etanercept biosimilar provides value over Enbrel.
A three-judge panel from the US Court of Appeals for the Federal Circuit on July 5 ruled that the 180-day notice of commercial marketing applies to all biosimilar applicants, giving a win to Amgen over Apotex. But in its latest interpretation of the US biosimilars law, the court appears to suggest the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.