Strategy

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.

While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.

A journey began eight years ago continues for Doc Generici – now rebranded as DOC Pharma – as it continues to diversify its offerings beyond conventional generic prescription pharmaceuticals.

Cosette Pharmaceuticals has made two key executive appointments as it looks to build up its business. Meanwhile, Canada’s CGPA has named a chair and vice-chair, and Chanelle and Neuraxpharm have announced their own executive changes.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

CMO Tahamtan Ahmadi explained Genmab hopes to do a deal in 2025 like its ProfoundBio acquisition in 2024 as the company seeks to develop more antibodies entirely on its own.

While biosimilars updates were thin on the ground as Biogen reported its full-year results, the segment nevertheless reported growth in 2024. Meanwhile, the firm also offered some comments on how it saw generic and biosimilar competition to its Tecfidera and Tysabri multiple sclerosis brands playing out this year.

Having secured approvals for the Eylea biosimilar in major markets such as the US and Europe, Formycon has signed a fresh licensing deal with Lotus Pharmaceutical, giving away rights to the asset in the APAC region.

Sales of spinal muscular atrophy drug Spinraza had an unexpected US boost in Q4 and Biogen may win US FDA approval for a high dose version this year, but Roche’s Evrysdi was just approved in a new tablet formulation.