Biosimilars

Generics Bulletin previews the most noteworthy and anticipated events for June 2025.

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Spanish biosimilars developer mAbxience has struck a deal with Italy’s Abiogen covering an undisclosed biosimilar for the Italian market.

Teva will now market biosimilar Herceptin in both the US and Europe, after penning an agreement with Singaporean firm Prestige BioPharma for its Tuznue rival to the monoclonal antibody to treat HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

Lupin is planning to make inroads into the Latin American biosimilars market through a deal with local player SteinCares for a ranibizumab rival to Lucentis.

Hikma is set to make its first launch into the competitive US biosimilars market after its Bio-Thera-partnered Stelara rival, Starjemza, was approved by the FDA.

Generics Bulletin reviews global regulatory developments across the world.