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Supreme Court Hints Biosimilar Route Might Be Preserved
The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.
The survival of the Affordable Care Act (ACA) without the individual mandate seemed a distinct possibility following oral arguments in the Supreme Court, and this bodes well for the survival of the Biologics Price Competition and Innovation Act (BPCIA), which is part of the ACA statute and enacts the pathway for biosimilar approvals.
“It’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down,” Chief Justice John Roberts said. The individual mandate dictated that individuals must have health insurance or pay a penalty for not having it, although the penalty was abolished in 2019. The argument before the court is whether the ACA and its provisions can be salvaged without the mandate or if they must be struck down in their entirety.
Roberts said “there seems to be compelling evidence” that the intent of Congress was for the “rest of the law to survive if an unconstitutional provision were severed.”
The potential loss of the BPCIA was cause for concern in the biosimilars community, where the pathway has enabled 18 biosimilars to come to market so far, making lower-priced versions of costly biologics available to many patients and thereby expanding access to treatment. It is believed that a chaotic interruption to the development of the biosimilars market could erupt without the BPCIA and until Congress develops patch-up legislation as a replacement.
A decision on the case, California v Texas, is expected in the spring of 2021.
For more about the Supreme Court hearing, visit AJMC.com.
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.
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: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Denosumab Biosimilars Earn Positive CHMP Opinion for Bone Loss and Giant Cell Tumor of Bone
November 26th 2024The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the denosumab biosimilars SB16 for all indications referencing Prolia and Xgeva.
