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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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
