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AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive.  Soliris® i...

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-relate...

STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar  to Genentech’s Lucentis® (Ximluci®) in North America.

Xbrane entered into a ...

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 ...