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FDA to Review Bevacizumab Biosimilar, While Roche Hopes to Defend Its Patent
Last week, Amgen and Allergan announced that the FDA will review data supporting the firms' Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.
Last week, Amgen and Allergan announced that the FDA will review data supporting the firms’ Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.
The FDA Advisory Committee will review the analytical, pharmacokinetic, and clinical data from studies on ABP 215, including the results of a phase 3 study that met its primary endpoint of demonstrating clinical equivalence to the reference product in patients undergoing treatment for non-squamous, non-small cell lung cancer. The study also demonstrated comparable safety and immunogenicity profiles for ABP 215 and the reference bevacizumab.
While Amgen and Allergan have said that they believe their product to be the first bevacizumab biosimilar submitted for consideration in the United States, the reference product’s manufacturer, Roche, sees competition brewing in Europe—the European Medicines Agency has confirmed that it is currently considering 2 applications for bevacizumab biosimilars.
Roche, in attempting to retain its hold on the $6.8 billion bevacizumab market, has asserted that its patent protection for bevacizumab extends until 2019. The firm filed a complaint in the US courts in response to Amgen and Allergan’s application, and seeks to bar the biosimilar product from the US market until the patent dispute has been resolved.
Roche’s argument hinges upon the so-called “patent dance” requirements as laid out in the Biologics Price Competition and Innovation Act. However, after this week’s Supreme Court ruling in Sandoz v Amgen, which held that the “patent dance” is optional, Roche may be forced to change its litigation approach.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
