AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial...
EMA confirms acceptance of Intas’ MAA for its ustekinumab (Stelara®) biosimilar
Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing...
Genentech, Roche and Chugai sue Biogen and Bio-Thera over Actrema® (tocilizumab) biosimilar
Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions,...
Biosimilars bill aiming to remove interchangeable requirement for pharmacy substitution reintroduced into US Senate
Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented,...
Dr Reddy’s proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) will be reviewed by FDA, EMA and MHRA
Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s...
Prime Therapeutics announces formulary recommendations for adalimumab biosimilars to AbbVie’s Humira®
Prime Therapeutics announced its 2023 recommendations for formularies that include AbbVie’s Humira® (adalimumab). The...
New indication alert: AZ and Daiichi’s Enhertu® (trastuzumab deruxtan) approved to treat unresectable or metastatic HER2-low breast cancer
AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC),...
Searle licenses Mabwell’s denosumab (biosimilar to Amgen’s Prolia®/Xgeva®)
The Searle Company Limited announced that it has entered into a license agreement with China’s Mabwell...
Publication Of Study Demonstrating Comparability Of AVT04 (Ustekinumab Biosimilar) And Stelara® In Moderate-To-Sever Chronic Plaque Psoriasis
A study comparing the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between AVT04 (ustekinumab...
Sanofi receives marketing approval for Dupixent® (dupilumab)
Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of...
Samsung Bioepis releases second US Biosimilars Market Report
Samsung Bioepis has released its second US Biosimilar Market Report. The quarterly report has updated price details...
Samsung Biologics and Novartis announce US$310M manufacturing deal
Samsung Biologics announced in a regulatory filing with Korea Exchange that it has signed a ₩511B (US$390M) contract...
BeiGene and Novartis end option for collaboration and licence agreement to commercialise ociperlimab
BeiGene announced in an SEC filing that it and Novartis have entered into a mutual termination and release agreement,...
Cigna to prefer four adalimumab biosimilars at its formularies
Cigna Healthcare, a pharmacy manager, announced it will prefer adalimumab biosimilars Boehringer Ingelheim’s Cyltezo®,...
CuraTeQ Biologics enters into exclusive licence agreement with BioFactura, Inc to commercialise its biosimilar to Janssen’s Stelara® (ustekinumab)
Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license...
Biogen’s BYOOVIZ® (ranibizumab) to be reimbursed in Quebec
Biogen Canada announced that Quebec will reimburse patients receiving BYOOVIZ® (ranibizumab), biosimilar to...