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.
Sure H.R. 3 could save the U.S. government hundreds of billions of dollars on drug spending, but that savings comes at a long-term cost in innovation that’s higher than the Congressional Budget Office (CBO) initially forecast.
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.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine).
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.
As the COVID-19 pandemic continues to impact the FDA’s inspection program, U.S. lawmakers are worrying about what that may mean for future drug approvals.
“We are . . . concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections,” the bipartisan leadership of the House Energy and Commerce Committee and its Health Subcommittee said in a July 22 letter to acting FDA Commissioner Janet Woodcock.
More than a decade after the Biologics Price Competition and Innovation Act became law and nearly six years after the first biosimilar launched in the U.S., the country’s first potential interchangeable is on deck awaiting an FDA decision.
The FDA took Amgen Inc. to task for promotions claiming Neulasta (pegfilgrastim) Onpro on-body injector is more effective than pegfilgrastim delivered via a prefilled syringe.
The U.S. Supreme Court, in a 7-2 opinion dismissing a challenge to the Affordable Care Act (ACA), removed a threat to the future of the Biologics Price Competition and Innovation Act (BPCIA) and the biosimilars pathway it created.
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