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Bio Relief: US FDA Rules On Biosimilars Naming
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.
Similar Persistence Rates Between Adalimumab New Starts, Switched Patients
December 7th 2024A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.
