The suspense is over: the US Food and Drug Administration (FDA) has made their decision.
As more biologics come off patent in the next few years, the opportunities for biosimilars and the impact upon the biotech and pharmaceutical industries are limitless. While it's exciting for physicians, patients, and payers, the US Food and Drug Administration's (FDA) regulatory ruling on biosimilar suffixes has increasingly taken on more urgency. Well, the wait is now over.
The FDA has determined that a suffix will help distinguish biosimilar products and avoid a substitution mistake--and it has has already included four additional letters on the end of each non-proprietory name for existing biosimilars: Filgrastim, the biologic drug Neupogen, becomes filgrastim-sndz, biosimilar Zarxio. Adalimumab (Humira) becomes adalimumab-atto (Amjevita).
At this point, only four biosimilar drugs are approved in the US, but are not considered interchangeable with their reference biologic. This means pharmacists cannot make a choice whether to give a patient a biosimilar as opposed to a biologic, which is a regular practice with generics and small-molecule drugs.
The new guidance says each suffix can not have a specific meaning attached to it and must include four lowercase letters.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.