Latest from Urtė Fultinavičiūtė
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.
Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.
Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
Outlook Therapeutics gave little detail about its next steps following a meeting with the US FDA, but said it was evaluating regulatory options toward approval. Meanwhile, expansion in Europe continues with a fresh Swiss commercial distribution deal.
