Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
Tot Biopharm International Co. Ltd.’s self-developed Pusintin (bevacizumab), a biosimilar to Roche Holding AG’s Avastin, has won marketing approval from China’s NMPA. It was approved for the treatment of patients with advanced, metastatic, or recurrent non-squamous non-small-cell lung cancer and those with metastatic colorectal cancer.
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.
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).
Shanghai Junshi Biosciences Co. Ltd. could receive an aggregate $1.1 billion from Coherus Biosciences Inc. for the rights to develop and commercialize Junshi’s anti-PD-1 antibody toripalimab in the U.S. and Canada. The deal is powered by Coherus’ core biosimilar business and is designed to steer the company into the business of immuno-oncology.
HONG KONG – South Korea’s Daewon Pharmaceutical Co. Ltd. has launched Terrosa, a teriparatide biosimilar for the treatment of osteoporosis, acquired from Hungarian firm Richter-Helm Biotec GmbH & Co KG. It’s the first biosimilar launch for the company.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market to reap $241 million at a valuation of almost $2 billion.
HONG KONG - With a corporate valuation of $1.04 billion, the South Korean biosimilar company Aprogen Inc. has become the country’s first biotech “unicorn,” according to U.S. market research firm CB Insights. Korea now ranks fifth, tied with Germany, in terms of the number of unicorns, with total of 11 unicorns, a term used to describe private ventures with $1 billion-plus valuations. The U.S has a total of 210 unicorns, followed by China with 102, the U.K. with 22 and India with 18.
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