Paul A. Calvo, Ph.D. was quoted in a recent FirstWord Pharma article discussing Amgen's status in the biosimilars space following last week's unanimous vote by the FDA's Oncologic Drugs Advisory Committee to approve Novartis' Zarxio, a biosimilar version of Amgen's Neupogen.
If granted, this will be the first U.S. approval of a biosimilar medicine, but it does not guarantee a successful launch of Novartis' new drug. Calvo states that "it is important to remember that the FDA has stated they will not oversee any of the patent issues for biosimilars and that patent certainty is not a prerequisite for approval. Biosimilar applicants and reference product sponsors will therefore be left to their own devices and if recent history is any indicator, clarity will not be coming any time soon."
Last year, Amgen sued Novartis for failing to turn over details of their biosimilar filgrastim production process. "Novartis appears to be testing the limits of the statute to gain clarity on what will be required to proceed down the commercialisation path with subsequent, more complex, biosimilar products where patent issues are much more complicated than those associated with Neupogen," says Calvo.
The full article is available to subscribers on FirstWord Pharma's website.