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Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions, Ltd in the District Court of Massachusetts in relation to Biogen’s BIIB800, (biosimilar tocilizumab).  Genentech alleges that Biogen’s product, manufacture...

Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimila...

Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab), has been accepted for review by the FDA. This follows acceptance of its DRL_RI dossier for review by the European Medicines...

Prime Therapeutics announced its 2023 recommendations for formularies that include AbbVie’s Humira® (adalimumab).  The pharmacy benefit manager will recommend coverage of the following adalimumab biosimilars to commercial clients: 

Amgen’s Amjevita® (low concentrat...

AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC), has been approved in China as a monotherapy to treat patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have receiv...

The Searle Company Limited announced that it has entered into a license agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and license the biosimilar drugs in Pakistan. 

In March 2023, Mabwell announced that it had received ...

A study comparing the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between AVT04 (ustekinumab biosimilar) and Janssen’s Stelara® in patients with moderate-to-severe chronic plaque psoriasis (PsO) has been published.   The authors report that the study...

Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are cont...

Samsung Bioepis has released its second US Biosimilar Market Report.  The quarterly report has updated price details of all products with launched biosimilars including updated 2023 Q3 average sale price (ASP) trends and wholesale acquisition cost (WAC) trends. For adalimum...