The FDA Introduces Naming Conventions for Biosimilars

September 1, 2015

Patient advocacy groups are praising the FDA for releasing a draft guidance for naming biosimilars.

Patient advocacy groups are praising the FDA for releasing a draft guidance that outlines the FDA’s proposed guidelines for naming biologics and biosimilars. A distinctive naming convention was needed to clearly identify biological products to improve pharmacovigilance and to clearly differentiate among biological products that have not been determined to be interchangeable, the FDA stated. 

The guidance, which was released on Thursday, suggests that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name. It suggests they adopt an FDA-designated suffix unique to each product. For example, the FDA nonproprietary name of a reference product could be “replicamab-cznm,” and a biosimilar to that product could be “replicamab-hixf,” the FDA stated on its blog, FDA Voice. But for interchangeable biological products, the FDA is seeking public comment to determine whether the nonproprietary name for such a product should include a distinct suffix, or whether it should share the same suffix as its reference product (e.g., the nonproprietary name of both the reference product and the interchangeable product could be replicamab-cznm). The American College of Rheumatology praised the FDA for issuing its draft guidance. The move, they said, was needed for patient safety.[[{"type":"media","view_mode":"media_crop","fid":"40970","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_8607542971149","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4253","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.0080003738403px; line-height: 1.538em; float: right;","title":" ","typeof":"foaf:Image"}}]] “The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Douglas White, MD, Chair of the ACR’s Committee on Rheumatologic Care, in a written statement. “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving.” The ACR previously issued a position statement calling on the FDA to enforce distinct names for biosimilars, and has spoken with FDA officials and submitted comment letters expressing its concerns for patient safety in instances where biosimilars are substituted without proper patient and physician notification. There have been some concerns about the complexity of biologics and the potentially life-threatening adverse reactions when biosimilars are substituted without physician and patient notification. This has led the rheumatology community to call for stricter oversight and more transparency in the notification and substitution process, the ACR stated. “The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective, without compromising their health or safety,” Dr. White concluded. Patient advocacy groups, like the Global Healthy Living Foundation (GHLF), applauded the move in the name of patient safety. "We believe this ruling is a major win for patients. Common sense prevailed. Different drugs will have different names. We hope regulatory bodies around the world will follow FDA’s lead," read a statement from the group. Like the FDA, it too is still considering the benefits of extending unique naming to interchangeable biologics. Earlier this year, the FDA approved the first biosimilar, Zarxio approved for use in severe chronic neutropenia and some cancers. Clinical trials are underway for many more. Biological products are among the medications used to treat conditions such as rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and various forms of cancer. More than 700 biosimilars and 245 biopharmaceutical, big pharmaceutical and generics companies are developing or already marketing biosimilars, according to a new industry report issued by BioWorld.  The draft guidance and proposed rule are slated for publication in Friday's Federal Register. Comments are due by Oct. 27 on the guidance and by Nov. 11 on the rule.