- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union
The Complete Guide to Monoclonal Antibody and Granulocyte-Colony Stimulating Factor Biosimilars Approved in the United States and European Union
Reviewed by Joseph P. Fuhr, Jr., PhD, professor emeritus, Widener University
Note: In the United States, products such as insulin, enoxaparin sodium, and hormones are regulated under the Federal Food, Drug and Cosmetic Act, not under the Public Health Service Act. While follow-ons of these products may be declared biosimilars in other regulatory territories (including the European Union), in the United States, follow-ons of these products are not subject to the Biologics Price Competition and Innovation Act’s pathway for biosimilar approval.
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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.
From Approval to Practice: Addressing the Hurdles in Biosimilar Integration
December 18th 2024Recent discussions at an Institute for Value-Based Medicine event highlighted the significant potential of biosimilars in reshaping the health care landscape, despite facing considerable barriers to adoption.
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.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
