AbbVie Criticizes FDA’s Approach to Biosimilar Labeling

AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ.

The criticism takes aim at the FDA’s June 22 response to the Senate HELP Committee, which stated that interchangeability information need not be included in biosimilar labeling because prescribers can obtain the information from the Purple Book.

But AbbVie contends the Purple Book is not capable of portraying what could be a complicated array of products with varying scopes of biosimilarity and interchangeability.

The drugmaker also argues that the labeling the FDA approved for Sandoz’s Zarxio biosimilar of Amgen’s chemotherapy product Neupogen (filgrastim) relies entirely on studies involving a different product without acknowledging that the studies weren’t conducted with Zarxio.

The omission is in direct contradiction to the agency’s statement in Amarin Pharma, Inc. et al. v. FDA et al. that it is materially misleading for a prescription drug’s label to fail to be specific when studies pertain to other, nonidentical products, AbbVie says.

The letter follows a citizen petition filed by AbbVie in early June claiming the FDA’s approach to biosimilar labeling — reflected in the March 6 approval of Zarxio (filgrastim-sndz) and its April guidance on demonstrating comparability to a reference product— omits material information.

Since then, AbbVie points out, a diverse group of stakeholders, including the Patients for Biologics Safety and Access and the Global Healthy Living Foundation, have joined in the press for distinct and transparent biosimilars labeling.

The FDA plans to issue draft guidance on biosimilar labeling later this year. Read AbbVie’s letter here: www.fdanews.com/8-15-AbbVie-Supplement.pdf. — Jonathon Shacat