Biotech | March 12, 2022
BioPharma’s Herceptin biosimilar Phase 3 results positive
The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile
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
The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad
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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