Celltrion Tightens Race For Biosimilar Drug Approval In U.S.
By Lori Clapper
Celltrion filed an application with the U.S. Food and Drug Administration (FDA) last week for the first ever approval of a monoclonal antibody. Remsima, the company’s biosimilar version of Jannsen's Remicade (infliximab), is also the second filing of a biosimilar drug through the FDA’s new 351(k) biosimilar pathway.
“After prior consultation with FDA, Celltrion conducted additional clinical trials (starting on October 2013 and lasting 6 months) to determine the bioequivalency of the originator products with Remsima,” Celltrion said in a company statement.
In a neck and neck race for approval, the company follows Sandoz, which filed the first biosimilar application last month for Zarzio, a biosimilar version of Neupogen (filgrastim).
Both Sandoz and Celltrion have regulatory hurdles to face before getting FDA’s nod, including strict FDA definitions of what a biosimilar actually is. In its guidance document, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, the agency explained that Biosimilar drugs will be held to a four-part standard, including:
- Not similar
- Similar
- Highly similar
- Highly similar with a fingerprint-like similarity
The challenge comes in that the FDA has not provided complete direction on how biosimilar drug products will fit into those categories. Not to mention, companies looking for approval of biosimilars could face naming challenges, since global regulators have not released final naming guidance. This issue has been debated by the World Health Organization (WHO) and FDA in recent weeks, in the attempt to determine what the drugs' names should be. The industry has been engaged in debate over whether or not the biosimilars are in fact similar enough to be interchangeable with the reference biologic on which their approval is based, Regulatory Affairs Professionals Society (RAPS) said.
Neither Sandoz nor Celltrion are seeking approval for untested products. Indeed, Celltrion has already obtained approval for Remsima, from over 50 countries worldwide. Both Remsima and Zarzio are approved in Canada, Japan and the EU.
Celltrion expects the FDA to approve Remsima by early 2015.