Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile
Alvotech expects AVT02 (adalimumab) will be marketed in the U.S., subject to regulatory approval, on July 1, 2023
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
BBL will gain Viatris’ global biosimilars business whose revenues are estimated to be USD 1 billion next year, along with its portfolio of in-licensed biosimilar assets
Under the terms of the agreement, Biogen will make an upfront payment of US $ 8 million to Xbrane
The companies will continue with their exclusive agreements, including commercialization of their current portfolio
Go-ahead for pivotal clinical trial which is expected to commence by March
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
The license agreement grants Dr. Reddy's the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia
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