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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...

Samsung Biologics announced in a regulatory filing with Korea Exchange that it has signed a ₩511B (US$390M) contract with Novartis to manufacture its products in Korea from 1 January 2023 through to the end of 2028. The exact products which will be produced at the plant hav...

BeiGene announced in an SEC filing that it and Novartis have entered into a mutual termination and release agreement, terminating their agreement (announced on 19 December 2021) under which BeiGene granted Novartis an exclusive time-based option to receive an exclusive lice...

Cigna Healthcare, a pharmacy manager, announced it will prefer adalimumab biosimilars Boehringer Ingelheim’s Cyltezo®, Sandoz’s unbranded adalimumab-adaz, and Sandoz’s Hyrimoz high-concentration formulation alongside the originator product, Abbvie’s Humira® on its national ...