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Samsung Bioepis and Organon announced the topline results for their interchangeability study for SB5 (Hadlima®), a biosimilar to AbbVie’s Humira® (adalimumab).  The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical stu...

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...