Drug Approval | April 18, 2022
Amneal achieves second U.S. biosimilars approval with Alymsys
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
Organizations to combine expertise to further develop AI/ML-powered drug design platform, delivering precise, effective, and life-changing medicines at scale
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
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