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Sandoz announced that it has received FDA approval for its Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira® in a citrate-free, high concentration formulation that it intends to launch in the US on 1 July 2023 pursuant to the licence granted in its settlement with AbbVi...

Luye Pharma Group announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the BLA submitted by Luye’s subsidiary Boan Biotech for denosumab (BA1102), biosimilar to Amgen’s Xgeva®. It is indicated for the treatm...

A new study published in Rheumatology has found that etanercept biosimilars (Biogen’s Benepali® and Novartis’ Erelzi®) demonstrated comparable efficacy to Pfizer’s Enbrel®.  The study is one of the largest to date, and showed that biologic-naïve rheumatoid arthritis patient...

Coya Therapeutics, Inc. announced an exclusive worldwide licensing agreement with Dr Reddy’s Laboratories, Ltd for Coya to use the Dr Reddy’s abatacept biosimilar (to BMS’ Orenica®) to develop and commercialise its subcutaneous combination product COYA302 (abatacept with CO...

Samsung announced that its Phase I clinical studies for SB17, biosimilar to Stelara® (ustekinumab), demonstrated pharmacokinetic bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in healthy volunteers.   Samsung will present the...

Samsung Biologics announced that it will commence construction of its fifth plant and its second Bio Campus to meet increased market demand.  Samsung Biologics will invest KRW 1.9T (~US$1.5B) to build the new facility with a 180,000L manufacturing capacity, bringing its tot...

Alvotech announced clinical studies support biosimilarity and comparability of its ATV04 (ustekinumab biosimilar) and Johnson & Johnson’s Stelara®.  The data will be presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

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A study published in Rheumatology International has concluded that there was ‘high comparability’ between Sandoz’s Rixathon® (rituximab) and Roche’s Mabthera®.  The Norwegian participants included adults with rheumatoid arthritis who had a mandatory biosimilar switch from M...