- The Food and Drug Administration no longer intends to alter the non-proprietary names of already approved biologic medicines, reversing course two years after setting out a plan designed to avoid the impression that biosimilars are somehow inferior to their branded counterparts.
- Biosimilars, which unlike generic drugs aren't exactly identical to the medicines they mimic, currently share the same generic name as their branded drug counterparts, plus a unique, four-letter suffix. The FDA grew concerned that the suffix could cause providers and patients to perceive biosimilars as somehow inferior, spurring the agency in January 2017 to announce plans to retroactively add a suffix to all existing biologic drugs, too.
- That plan is now set aside. "After careful consideration, the FDA has determined that the crucial public health goals of the naming policy could still be accomplished by applying the naming convention to newly licensed biological products, while avoiding the negative consequences raised by extending the naming convention to previously licensed products," FDA Commissioner Scott Gottlieb said in a March 7 statement.
Over the past 18 months or so, the pace of biosimilar drug approvals in the U.S. has accelerated, and four more of the copycat biologics have successfully launched commercially.
Still, the U.S. biosimilar market remains nascent and far smaller than in Europe, where biosimilars have been available for significantly longer.
That still-emergent nature is reflected in the FDA's shifting position on biosimilar naming — regulatory minutiae that carries consequences for how the drugs are monitored and marketed. And, while in the weeds, it's a hot-button issue for the companies that make biosimilars.
The Association for Affordable Medicines, a lobby group for the generic industry, said it was reviewing the FDA's new guidance. However, Christine Simmon, director of AAM's Biosimilars Council, did note that the "current requirement of suffixes presents a significant, artificial barrier to biosimilars."
Since approval of Novartis' Zarxio (filgrastim-sndz) in March 2015, biosimilars have cleared regulator's desk in the U.S. with a four-letter suffix attached to the end of the generic name of the molecule they mimic.
Examples of branded and generic names for several top-selling biologics and their biosimilar copies
|Originator branded name||Originator generic name||Biosimilar branded name||Biosimilar generic name|
SOURCE: Food and Drug Administration
Suffixes, according to the FDA, primarily serve to boost patient safety. By uniquely identifying the biosimilar, the four-letter identifiers help track biosimilar use following approval, a feature important for monitoring for drug-specific safety issues.
This is particularly useful for biologics and biosimilars, which are highly similar but not chemical copies of each other in the way generics are for small molecule drugs.
Biosimilar proponents, however, have argued the suffixes could contribute to the impression that biosimilars are more risky or differ clinically from the biologic reference product. The FDA's solution was to require all biologics, including those already on the market, carry a suffix — a task the agency now says would be too costly and do little to advance pharmacovigilance.
The Biosimilars Forum, an industry group set up to promote biosimilars in the U.S., disputed that argument. "Today's announcement by the FDA is a direct blow to biosimilars uptake in the U.S.," said a statement from the group, which counts Merck & Co., Pfizer and Novartis among its members. "The decision abandons the retrospective addition of a suffix to origination biologics, leading to an unsubstantiated notion that strict pharmacovigilance is only essential for biosimilars."
Biosimilars and newly approved biologic drugs will still be approved with a suffix, the FDA said, as will any interchangeable products that secure FDA approval. Biologic drugs, such as insulin, that were approved before the creation of the Biologic License Application pathway would not be subject to the naming convention.
Since the FDA began the practice, all 17 biosimilars approved have been cleared with a suffix, while 27 originator biologics have reach market with the four-letter additions.
"We expect that as time goes on, and more biological products are introduced to the market with distinguishable suffixes, patients and providers increasingly will understand that the suffixes reflect a consistent naming convention and are not an indicator of product quality," Gottlieb said in his statement.