Biosimilars Statistical Guidance Reflects Early Development Approach

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.

The guidance is part of the FDA’s effort to encourage more biosimilar development by streamlining approval requirements and lowering development costs.

The new guidance says comparative clinical trials are not a prerequisite for all biosimilars, a notable step for the FDA, but the commissioner added that biosimilar prices should be significantly lower than the reference product at launch.