A lawyer’s look into the competition provided by biosimilars to biologic therapies has highlighted how this contest differs from generic competitors challenging branded drugs.
Writing in her firm’s regular blog on the US Food and Drug Administration (FDA), Sara Koblitz, an associate at Hyman, Phelps and McNamara, gives her reaction to a Citizen Petition posted this week by Pfizer (NYSE: PFE), the world’s largest pharma company.
Pfizer has requested FDA guidance on sponsor communications about biosimilars, raising concerns that the lack of confidence in these copies results from reference product sponsors spreading false and misleading information and has caused a stymying of market acceptance and uptake. This risks denying the US healthcare system with the potential savings that these cheaper versions offer.
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