Biosimilars
While Biocon intends to address the CRL, the company has not established a timeline for the resubmission of data and hopes that the FDA will rapidly review the BLA when it does submit the data.
Shares of Coherus BioSciences are climbing in premarket trading after the company announced the FDA greenlit the company’s Humira biosimilar Yusimry.
Biopharmaceutical firm Alvotech Holdings announced merger plans with Oaktree Acquisition Corp. in a deal that will create a combined entity worth around $2.25 billion.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
Biosimilars have gained traction in Europe, but not in the U.S. AbbVie’s Humira is often made as an example of how companies are using legal tactics to delay biosimilar competition.
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
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