Vive la similitude

Pending FDA decisions are pitting biosimilars companies against each other

While there always has been contention over the rules of the road for biosimilars, the battle lines have shifted since the Biologics Price Competition and Innovation Act was enacted as part of the Affordable Care Act. While previously the split was between innovator and generics companies, now the divide is between biosimilars manufacturers.

Those divisions were on display at a public meeting convened by FDAthis month to discuss its biosimilars pathway. The meeting included discussion of two critical and contentious issues: standards for classifying a follow-on product as interchangeable with an innovator; and whether and how to allow biosimilars applications to include comparative data about innovator products that are only approved outside the U.S.

There is broad support among innovators and prospective biosimilars manufacturers for FDA's draft biosimilars guidance documents, but the agency still must make tough decisions on critical issues that the drafts did not fully address. These decisions will set the scientific and commercial parameters for the emerging biosimilars sector.

One camp hopes to leverage characterization technology to minimize or even eliminate clinical trial requirements, as well as to quickly obtain interchangeability status. The other camp includes companies that expect to rely more heavily on clinical data to make the case for safety and efficacy while using marketing muscle to overcome skepticism about similarity.

FDA's guidance emphasizes the role of

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