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BioWorld - Friday, February 13, 2026
Home » Topics » Drugs » Biosimilar

Biosimilar
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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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South Korea's Samsung Bioepis to provide Enbrel biosimilar to Brazil market

Sep. 18, 2019
By Jihyun Kim
HONG KONG – South Korean biopharmaceutical company Samsung Bioepis Co. Ltd., based in Incheon, will expand into the Brazilian market with Brenzys (etanercept), having recently signed a marketing agreement with Brazil's Ministry of Health. The drug is now available through the country's public health system, Sistema Único de Saùde (SUS).
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With development slow, experts concerned about biosimilar pharmacovigilance

Sep. 5, 2019
By Sergio Held
SAO PAULO, Brazil – Pharmacovigilance is emerging as a key concern for the development and distribution of biosimilars in Latin America. Experts gathered this week for the BIO Latin America conference focused on the issue and highlighted what they see as a key concern, one that is holding back the spread of that new class of drugs throughout the region.
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U.S. biosimilar market 'thriving' without government intervention

Sep. 3, 2019
By Mari Serebrov
Drug pricing legislation will be high on the to-do list when the U.S. Congress returns from its August recess next week, as both the Senate and the House are expected to take action this month on competing packages of provisions aimed at controlling prescription drug prices.
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Another Humira biosimilar gets FDA nod, as Korea's Samsung Bioepis joins launch wait list

July 29, 2019
By Jihyun Kim
HONG KONG – Samsung Bioepis Co. Ltd., a South Korean biosimilar developer, said the FDA approved its July 2018 application for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbvie Inc. blockbuster TNF-blocker Humira (adalimumab).
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