Biotechnology Companies Seek Changes, Clarification in Biosimilar Draft Guidance

| 16 May 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) draft guidance on biosimilars attracted general praise and some pointed criticism at a public meeting held 11 May as companies jockeyed for more flexibility and clarification, reports Genetic Engineering & Biotechnology News (GEN).

The meeting drew a huge amount of testimony, presentations and general comments from a host of companies and organizations, including Abbott, Amgen, Novo Nordisk, Pfizer, PAREXEL, BIO, Eli Lilly, Mylan, GPhA, Genentech, Teva and Hospira.

While some companies have been sharply criticizing the draft guidance for months - see Regulatory Focus's 26 April story "Biosimilars Guidelines Attract Attention, Criticism" - FDA's 11 May meeting saw a more measured response, writes GEN.

"Executives from a dozen biopharma companies, however, pressed for greater flexibility in the definition of proteins, tighter standards in naming and labeling follow-on biologics, as well as more details on moving drugs through agency approvals," said GEN.

Companies are also concerned about several other issues, including how to protect trade secrets, how much data will be required to approve a biosimilar product, whether pediatric trials will be necessary and how interchangeable the products will be once approved.

GEN - FDA's Hearing for Biosimilars Showcased Issues Ranging From Definitions to Study Requirements to IP

Docket Folder Summary - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments

Regulatory Focus - FDA Releases Long-Awaited Guidances on Biosimilar Price Competition and Innovation Act

Regulatory Focus - Biosimilars Guidelines Attract Attention, Criticism