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BioWorld - Saturday, April 11, 2026
Home » Topics » Drugs » Biosimilar

Biosimilar
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Shanghai, China, stock market illustration

Bio-Thera launches $241M pre-revenue IPO on Shanghai’s STAR; shares up 83% on debut

Feb. 25, 2020
By Elise Mak
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.
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Shanghai, China, stock market illustration

Bio-Thera launches $241M pre-revenue IPO on Shanghai’s STAR; shares up 83% on debut

Feb. 21, 2020
By Elise Mak
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.
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Biosimilar drugs

FDA prepares for NDA-to-BLA deeming day

Feb. 20, 2020
By Mari Serebrov
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.
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Pricing could assume a larger role for would-be blockbusters

Feb. 10, 2020
By Mari Serebrov
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.
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Globe showing Asia-Pacific region

Mundipharma to commercialize Samsung Bioepis’ biosimilars in Taiwan and Hong Kong

Jan. 14, 2020
By Jihyun Kim
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.
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Drug vials and syringe

CDER approval numbers show biosimilar advance, steady pace of novel BLAs

Jan. 7, 2020
By Mari Serebrov
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.
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Businessman riding unicorn atop arrows in the clouds

Aprogen listed as South Korea’s first biotech unicorn

Dec. 17, 2019
By Jihyun Kim
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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Businessman riding unicorn atop arrows in the clouds

Aprogen listed as South Korea’s first biotech unicorn

Dec. 16, 2019
By Jihyun Kim
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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Seoul, South Korea

Daewon wins Forteo biosimilar marketing approval in Korea

Nov. 6, 2019
By Jihyun Kim
HONG KONG – Daewon Pharmaceutical Co. Ltd., based in Seoul, South Korea, has received the approval from the country's Ministry of Food and Drug Safety (MFDS) to market Terrosa, a biosimilar teriparatide for osteoporosis treatment developed by Richter-Helm Biotec GmbH & Co. KG, of Hamburg, Germany.
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Celltrion's Herceptin biosimilar enters Middle Eastern market via Iraq launch with Hikma

Oct. 2, 2019
By Jihyun Kim
HONG KONG –South Korea's leading biopharmaceutical developer, Celltrion Inc., has launched its early/metastatic breast and gastric cancer biosimilar Herzuma (trastuzumab) in Iraq. It is Herzuma's first foray into the Middle Eastern region.
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