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Breaking News: Supreme Court Declines to Hear 'Patent Dance' Case
July federal appeals court ruling will not be heard.
According to Reuters, The US Supreme Court has declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market.
The justices opted not to take up Apotex Inc's appeal of a July federal appeals court ruling that could delay the Canadian generic drug maker's launch of so-called biosimilar versions of California-based Amgen Inc's Neulasta, used to fight infection in cancer patients.
The biosimilars law gives the maker of a biologic drug 12 years of exclusive rights before the US Food and Drug Administration can approve a biosimilar. It also states that a biosimilar maker must give the original biologic drug maker 180 days' notice before launching its copycat version.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
