Intellectual Property
Despite recent wins on streamlining and interchangeability, the US biosimilars industry continues to face challenges such as IRA price negotiation, dysfunctional pricing dynamics and PBM distortions, says AAM Biosimilars Council chief Alex Keeton.
Serial patent litigations have become a loophole in the Hatch-Waxman Act, disbalancing the scale of innovation and competition, said Jon Potter, executive director of the newly established Coalition Against Pharma Patent Abuse, in an exclusive Generics Bulletin interview.
Formycon expects its aflibercept biosimilar to enter European markets from the end of spring, as commercial paths also open up in Latin America and Asia Pacific countries.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
Merck, Johnson & Johnson, AstraZeneca and Roche are among the big pharma manufacturers that will face substantial exclusivity losses in the US this year.
After losing US patent litigation against Amgen over Enbrel and failing to gain traction with a separate antitrust lawsuit, Sandoz isn’t giving up just yet. The firm has just filed an appeal in response to the latest district court dismissal.
As the US Supreme Court prepares to review litigation over skinny-label generics with carved-out indications, Hikma has once again won the backing of the US solicitor general for its position.
In a petition filed to HHS, non-profit Public Citizen requested the current administration to use its statutory authority to allow earlier generic competition for Novo Nordisk and Eli Lilly’s GLP-1 blockbusters.
AAM president and CEO John Murphy summarized a year of progress for the off-patent industry in front of an audience of generics and biosimilars industry delegates at the AAM’s Access! 2026 annual conference – but also said more efforts were needed to create a sustainable future environment.
Moves to issue a compulsory license for Lilly’s GLP-1tirzepatide products Mounjaro and Zepbound come as Brazil prepares to make its own versions of Novo Nordisk’s semaglutide and liraglutide.
Long-running litigation between Teva and GSK over a skinny-label generic carvedilol version of Coreg has ended not with a bang but with a whimper, after the two firms settled on undisclosed terms.
Do Zydus and Lupin’s settlements of Myrbetriq (mirabegron) US patent litigation with Astellas constitute a win or a loss?