Pharmacy groups urge consistent naming of biosimilars
The FDA is expected to decide whether to approve Celltrion's biosimilar Remsima this year.
A group of pharmacists, drugstore chains, hospital supply chain organizations and payers—including private insurers, unions and PBMs—urged the FDA to forgo allowing different names for biosimilars and biologics.
Allowing for different names would lead to safety issues and confuse healthcare providers, the group of 19 organizations said in a June 30 letter to Dr. Stephen Ostroff, the FDA's acting commissioner. They include the American Pharmacists Association, America's Health Insurance Plans, the California Public Employees Retirement System and Express Scripts.
Biosimilars are expected to help lower costs, in part by being less expensive than the original biologic versions of the drug but also by creating competition. The FDA in March approved Zarxio, the first biosimilar in the US. Zarxio, a biosimilar version of Amgen's anemia drug Neupogen, is marketed by Novartis's Sandoz business.
A report released in December by Express Scripts estimated that the entrance of Zarxio and Celltrion's Remsima, a biosimilar version of Johnson & Johnson's rheumatoid-arthritis therapy Remicade that is already available in Europe, could generate $22.7 million in savings over the next nine years in the US market. Celltrion's CEO has said he expects the FDA to approve Remsima later this year.
But the FDA's position regarding how so-called reference biologics, biosimilars and interchangeable biologics should be named is unclear at this time.
“Requiring different [international nonproprietary names] for biologics and biosimilars could lead to patient and prescriber confusion, increasing the possibility of medication errors, and would also effectively separate the biosimilar from existing safety information about the underlying molecule,” the organizations stated.
The letter came in response to biosimilars guidance the FDA issued in April, a spokeswoman for the Healthcare Supply Chain Association said in an email.