FDA to Hold Biosimilar Rules Hearing - BIO Gives Its Positions

Previously, the FDA had announced that it will be holding public hearings on November 2nd and 3rd to get feedback toward forming regulations for the approval of biologics.  Today, I received a newsletter from the industry group BIO detailing their key positions on the matter.

 

Let's give you the highlights:

Patient safety

• Approval of biosimilars should be based on the same rigorous standards for the approval of pioneer biotechnology products
• Clinical trial data are fundamental to evaluating and demonstrating safety and efficacy of biosimilars for patients
• Biosimilars must be properly evaluated through post-marketing surveillance
• Biosimilars should receive a nonproprietary name readily distinguishable from the pioneer product

Recognize scientific differences between drugs and biologics

• Versions of a biologic made by different manufacturers must be evaluated on a case-by-case basis
• Small product or manufacturing differences in biologics can result in significant differences in safety and effectiveness

Maintain physician-patient relationship

• The existing science is not sufficient enough to establish interchangeability
• Patients should not be given biosimilars unless prescribed by their physician

Preserve incentives for innovation

• Include substantial nonpatent exclusivity where follow on manufacturers can't cite pioneers' data
• Biologic products should not be approved until all statutory protections are no longer in effect for the pioneer product
• Any biosimilars regulatory pathway should not create special patent litigation rules that favor biosimilars manufacturers

Transparent statutory and regulatory processes

• Manufacturers of innovative products should be provided the opportunity to engage Congress and other key stakeholders in a public process in the establishment of a biologics regulatory pathway
• The FDA should follow a transparent and public process in determining data requirements for follow-on approvals


Continue to prioritize FDA review and approval of new therapies

• Make sure that new biosimilar applications do not harm the FDA's ability to efficiently review new drugs and biologics
• New treatments should continue to have highest review priority


In summary

• Make it hard for biosimilars to be approved
• Don't allow easy substitution once approved
• Provide more incentives/protections to pioneer drug makers
• Review our applications before the agency first
• Show us publicly that you are following these steps

That about does it.  As lobbyists they appear to be earning their keep.

Posted by Bruce Lehr October 12th 2010.