With licensed Humira (adalimumab) biosimilar competition a little more than a year away in the U.S., Abbvie Inc. is trying to fend off competitors that have not signed an agreement with the North Chicago-based company.

Shanghai Henlius Biotech Inc.’s self-developed Hanbeitai (bevacizumab biosimilar) has received marketing approval from China’s NMPA.

With the U.S. biosimilar pathway clearly developed, industry and the FDA are turning their attention to interchangeables in the third iteration of the biosimilar user fee agreement (BsUFA).

Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.

Enacting provisions to control U.S. prescription drug prices remains a top priority with many members of Congress as they push through the Biden administration’s budget agenda – despite warnings that government price controls on drugs would come at the cost of innovation.

Biogen Inc. and Samsung Bioepis Co. Ltd. gained FDA clearance for Byooviz (ranibizumab-nuna), a biosimilar that references the VEGF therapy Lucentis (ranibizumab) from Roche Holding AG, as a treatment for wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization. Byooviz is the first ophthalmology biosimilar to win the go-ahead in the U.S., and was approved in the EU on Aug. 18, 2021, followed by the U.K. on Aug. 31, 2021.

Samsung Bioepis Co. Ltd. has emerged as the first company to obtain marketing authorization from the EMA for a biosimilar of Lucentis (ranibizumab), a significant development for the Korean biosimilar specialist. The approval comes less than two months after the company received a positive opinion from the EMA’s CHMP for Byooviz (ranibizumab), formerly called SB-11.