“For those of us who believe in a free market, it is really important that the market works well,” FDA Commissioner Stephen Hahn said March 9 at a public workshop on ensuring a U.S. biologic marketplace that includes sustainable biosimilar and interchangeable competition.
The first wave of biosimilars began lapping at U.S. shores five years ago when the FDA approved Sandoz Inc.’s Zarxio on March 6, 2015, giving it a label identical to that of its reference biologic, Amgen Inc.’s Neupogen (filgrastim). But the tsunami of biosimilars, and the multibillion dollars of savings they were expected to bring, has yet to wash ashore.
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.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market, a Nasdaq-style tech board, to reap $241 million at a valuation of almost $2 billion. Its share price soared more than 83% during its first trading day.
With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
No matter how effective it is, a drug is worthless if the people who need it can’t afford it. That’s been almost an anthem for patients and policy wonks testifying before U.S. Congress on drug prices.
HONG KONG – Global pharmaceutical company Mundipharma Pte Ltd. is gaining exclusive commercialization rights in Taiwan and Hong Kong to four biosimilar candidates from South Korean biopharma Samsung Bioepis Co. Ltd. targeting immunology and oncology.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
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.
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.
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