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On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.  This is th...

On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in Europe and ROW, enabling Biocon to launch Yesafili® in the UK in January 20...

On 12 December 2025, Celltrion announced that it has successfully secured reimbursement coverage for Avtozma® IV, biosimilar to Roche’s Actemra® (tocilizumab), in the US, having signed a listing agreement with Synergie Collective, one of the top five prescription drug benef...

On 12 December 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its December 2025 meeting, including positive opinions for two biosimilars.

Bio-Thera/STADA’s Gotenfia® (BAT2506), biosimilar to Janss...

At its December 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for a number of biopharmaceuticals.

Among these, Regeneron/Bayer’s Eylea® 8mg (aflibercept) 114.3 mg/ml solution for ...

On 11 December 2025, Bristol Myers Squibb announced that the FDA has granted priority review to its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine chemotherapy for adult and paediatric (...

On 10 December 2025, Polpharma Biologics announced that it has entered a licence agreement with Brazilian pharmaceutical company, Libbs Farmacêutica, for the commercialisation of an unnamed biosimilar for autoimmune diseases in Brazil.

Under the agreement, Polpharma ...