Apr. 16, 2012 marked the closing date for submitting comments on FDA’s draft guidance documents clarifying the approval process for biosimilars. More than 35 pharmaceutical companies, trade associations, and patient advocacy groups submitted public comments on the guidance documents, which are available here.
A careful slog through the comments, revealed a few common issues, but also some topics that reflected the commentator’s industry outlook. Both BIO and PhRMA, industry trade groups, commented on the importance of protecting the innovator’s data until the period of exclusivity had expired, and also requested that the criteria for granting exclusivity be further clarified.
More than a few of the commentators asked for clarification around interchangeability. The guidance document has little detail on the topic, other than defining it as an approval designation permitting free substitution with the innovator product. Companies including Elan, Bayer, and Novo Nordisk asked that the agency provide more detail around the requirements for interchangeability, both in terms of product characterization and the sequence of steps to follow to obtain that designation.
While the abbreviated biosimilars pathway is intended to reduce the amount of clinical testing required for approval, there was a call from several commentators, including Elan, Novo Nordisk, the Alliance for Safe Biologic Medicines, and Amgen to preserve some requirements for clinical studies to ensure patient safety. According to Elan, there should be no cases where biosimilarity to a reference product, particularly for a monoclonal antibody, should be demonstrated by analytical means alone.
FDA will convene for a public hearing on May 11, 2012 to hear further commentary on the guidances, and I’m looking forward to hearing more on the topic. For those who don’t live near the FDA campus, the event is being webcast: more information here.