Healthcare Payers and GPhA Push for Same Name Biosimilars
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. The groups hope the proposal will be adopted by FDA in upcoming guidance on biosimilars naming.
A group of 32 pharmacies, health insurers, unions and pension plans, in a July 1 letter to FDA Commissioner Margaret Hamburg, say that multiple names might confuse consumers and make them unnecessarily hesitant to take a biosimilar.
In releasing the letter, GPhA also pointed to another benefit of same name biosimilars raised by the National Council for Prescription Drug Programs: they will head off discrepancies in drug databases and tracking systems that would result from multiple names for the same product.
Major labor unions like the AFL-CIO and AFSCME, as well as insurance and drug providers including American Health Insurance Plans, Walgreens and CVS Caremark signed on to the letter. Pension funds and trusts also signed on, according to GPhA President and CEO Ralph Neas, because they want to reduce healthcare costs for retirees by shifting patients to biosimilars when they are available.
The letter points out that shared names between biosimilars and their reference product are already employed in the EU, Canada, Australia and Japan and have been well accepted.
The naming issue is expected to be the subject of the next draft guidance from the FDA on biosimilars, though the agency hasn’t given any indications yet about what naming scheme it will favor.
Advocates for giving biosimilars different names from their reference products say patients and healthcare providers should know when a biosimilar is being taken so they can assess which drug is the best choice on a case-by-case basis. — Bryan Koenig
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.