FDA Plans Biosimilars Development Meeting Guidance in 2014

The FDA plans to issue draft guidance by mid-2014 on the various product development meetings included in its proposed biosimilars user fee program. The program includes four such meetings, which allow for open sponsor-FDA communication during the development process, after an IND is filed and before a biosimilar 351(k) is filed. They also encourage multiple development approaches — a necessity for a biosimilars approval pathway, Momenta Pharmaceuticals Senior Vice President Bruce Leicher said Dec. 16 during the final public meeting on the proposed user fees.
Drug Industry Daily