Biosimilars
San Jose-based Rani Therapeutics reported its fourth quarter and full-year 2021 financial results. The company hit major milestones this year, including the recent launch of the RaniPill High Capacity,
Releuko is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients.
AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.
Biocon Biologics has acquired its partner Viatris’ biosimilars assets. The transaction is part of an effort to create a global, vertically-integrated biosimilars leader.
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.
PRESS RELEASES