Biosimilars
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.
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.
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.
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.
As Stada awaits the imminent closure of a deal that will see it come under the ownership of CapVest, the firm has reported 2025 sales that grew by 6% to €4.3bn, boosted by a double-digit biosimilars increase that drove Specialty sales above €1bn for the first time.
Merck, Johnson & Johnson, AstraZeneca and Roche are among the big pharma manufacturers that will face substantial exclusivity losses in the US this year.
Celltrion has added a subcutaneous formulation to its Avtozma biosimilar in the US, completing a dual-presentation strategy aimed at matching Actemra and improving uptake in a market where biosimilar penetration has so far remained limited.
Sandoz has struck a new deal with Samsung Bioepis covering up to five early-stage biosimilars, expanding an existing alliance as the Swiss-based firm ramps up investment, reorganizes its business and targets a wave of upcoming biologics loss-of-exclusivity opportunities.
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.
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.
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.
The latest biosimilars guidance from the FDA – which promises to further streamline applications by making it easier for developers to rely on non-US comparator products – has been warmly received by the off-patent industry.
Genentech has asked the US International Trade Commission to investigate Biocon and related entities over alleged infringement tied to pertuzumab biosimilars, seeking remedies that could block imports into the US.
As the US biosimilars market continues to evolve, Cardinal Health’s director of biosimilars Dracey Poore talks to Generics Bulletin for an exclusive Q&A.
Deal pairs SteinCares’ regional commercialization platform with Shilpa Biologicals’ development and manufacturing capabilities for an undisclosed biosimilar.
Sandoz has unveiled a major reorganization of its generics and biosimilars operations into two distinct businesses, bringing in Ferring and Merck veteran Armin Metzger to lead a new global biosimilars unit while at the same time assigning existing executives to generics roles.
Deal after deal, Formycon was inching toward closing the gap in its annual guidance. Still, it was not enough to meet the goal, as the German biosimilars developer’s preliminary financial report reveals.
Even Amneal, a prominent off-patent player, is not immune to generic competition, as its Parkinson’s disease drug Rytary is expected to take a hit.