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Teva and Alvotech announced they have agreed to expand their existing strategic partnership agreement for the US with subordinated convertible bonds to be issued to Teva for USD$40M.

The expansion to the existing strategic partnership relates to exclusive commerciali...

A Sandoz/Bio-Thera comparability study has demonstrated similarity between BAT1706  (bevacizumab) and Genentech’s Avastin® (bevacizumab) in terms of all physicochemical and functional attributes.

BAT1706 is currently under regulatory review by the FDA (BLA accepted o...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended for the t...

BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for its tislelizumab product, co-developed with Novartis.  It is seeking approval for tislelizumab as mono...

Bristol Myers Squibb announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Opdivo® (nivolumab) as a monotherapy for the adjuvant treatment of adults and ...

MSD announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-cont...

Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly...

Sandoz announced that it will invest US$90M to build a Biosimilar Technical Development Centre in Ljubljana, Slovenia by 2026.  The site will house an end-to-end drug substance and product development centre, becoming a ‘key location’ for Sandoz’s biosimilar product develop...