FDA Plans Biosimilars Development Meeting Guidance in 2014 FDAnews Drug Daily Bulletin Dec. 20, 2011 | Vol. 8 No. 247
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The FDA plans to issue draft guidance by mid-2014 on the various product development meetings included in its proposed biosimilars user fee program.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.
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