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The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®.  The company presented the final results of its 40 week clinical trial during the American College o...

Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), ...

Alvotech and its EU partner Stada announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ustekinumab Uzpruvo (AVT04), biosimilar to Janssen’s Stelara®.  This is the first positive CHMP o...

Lupin Limited announced that it has executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE...

Biocon Ltd announced its consolidated financial results, including a 97% increase in revenue year on year for its biologics subsidiary, Biocon Biologics.  Biocon reported that this was largely driven by Biocon Biologics’ acquisition of Viatris’ biosimilars business an...

A pre-filled pen presentation of Janssen-Cilag’s Stelara® (ustekinumab) injection (90mg/1mL and 45mg/0.5mL) has been listed on the Australian Register of Therapeutic Goods.

Sandoz announced the inauguration of its new Biosimilar Development Center in Holzkirchen, Germany.  Sandoz invested €25 million in the Holzkirchen lab and received support from the Bavarian State government.  The lab will be a key site for Sandoz biosimilar development.

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents.  The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food...