BioPharmaceutical
Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.
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.
Bio-Thera has added India to its BAT2506 partnership with Intas, granting exclusive commercialization rights and expanding a global network spanning the US and Canada, as the firm builds its presence in the emerging golimumab biosimilars market.
More than a dozen semaglutide generics hit the Indian market at sharp discounts post LOE for Novo Nordisk’s GLP-1 RA molecule, setting the stage for a high-octane battle in the diabetes and obesity segment. Can Novo hold steady amid the avalanche and what are KOLs looking for?
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
Henlius is advancing its nivolumab biosimilar HLX18 into Chinese trials, as it expands a global oncology pipeline. In 2025, the firm’s strong revenue growth was offset by rising R&D investment amid increasing contributions from overseas partnerships.
Chugai’s partnering office in South San Francisco advances the Japanese company’s business development activities in the US beyond its venture fund established in Boston in 2023.
Natco has announced a 90% difference in the price of its semaglutide generic in multi-dose vials versus originator Novo Nordisk’s Ozempic pen ahead of launch tomorrow, as Novo’s patents on the product expire today. Its pen will be 70% cheaper.
Amid “significant uncertainty” for the off-patent industry caused by the war in Iran, the IGBA has warned that a prolonged conflict “could make solvent supply a critical concern” while escalating costs and squeezed margins could affect the long-term sustainability of affordable medicines.
Alvotech is shifting toward dual-source manufacturing and operational execution as it addresses FDA setbacks, expands its biosimilar pipeline and drives growth through global launches, with US approvals representing key upside to its 2026 outlook.
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.
Zydus’s investment in a differentiated drug-device combination for semaglutide has led to a win-win GLP-1 co-marketing deal with Lupin, even as the Indian drug regulator keeps a watch on advertising activities.