SEOUL, Aug. 21 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Friday it has won approval from European authorities for the sale of its anticancer biosimilar drug, Aybintio. The European Commission (EC) accepted Samsung Bioepis’ application to sell the bevacizumab biosimilar, also known as SB8, which references Switzerland-based Roche Holding’s blockbuster pill [...]
SEOUL, June 15 (Korea Bizwire) — South Korean pharmaceutical firm Samsung Bioepis Co. said Monday that it has won approvals in major countries to conduct clinical trials for its new ophthalmology biosimilar candidate. SB15 is a biosimilar candidate referencing Regeneron Pharmaceuticals Inc.’s Eylea, a blockbuster therapy to treat age-related (wet) macular degeneration (AMD). It is [...]
SEOUL, April 16 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Thursday its breast cancer biosimilar Ontruzant is now available in the United States. Global health care company MSD has begun distributing the biosimilar that references Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, in the world’s largest pharmaceutical market, Samsung Bioepis [...]
SEOUL, Mar. 9 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Friday its biosimilar cancer drug Ontruzant has begun selling in Britain following approval from a European regulator. Global health care company MSD has begun distributing the biosimilar that references Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, in the country, Samsung [...]
SEOUL, Nov. 20 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Monday it has won approval from European authorities for the sale of its biosimilar drug Ontruzant. The European Commission (EC) accepted Samsung Bioepis’ application to sell the biosimilar referencing Switzerland-based Roche Holding’s Herceptin, also known as Trastuzumab, the company said. The [...]
SEOUL, Oct. 25 (Korea Bizwire) — South Korean pharmaceutical firm Samsung Bioepis Co. saw its sales of biosimilar products released in Europe hit US$257 million through the third quarter of this year, data showed Wednesday. Samsung Bioepis said the sales of Benepali released in Europe came to $253 million over the January-September period, compared with [...]
SEOUL, Aug. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Friday it has won approval from European authorities for the sale of its biosimilar drug Imraldi. The European Commission (EC) accepted Samsung Bioepis’ application to sell the biosimilar referencing AbbVie Inc.’s Humira, the company said in a regulatory filing. The drug [...]
SEOUL, Aug. 21 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Monday that it has reached an agreement with Japan-based drug giant Takeda Pharmaceutical Company Ltd. to jointly develop new original drugs in a bid to expand its business area beyond copies of drugs. Under the partnership, the two will develop novel [...]
SEOUL, Jul. 25 (Korea Bizwire) — South Korean biopharmaceutical firm Samsung Bioepis Co. said Tuesday that its biosimilar drug Renflexis was launched in the United States following the approval of the U.S. Food and Drug Administration (FDA). In April, the FDA approved Renflexis — a biosimilar referencing Janssen Biotech, Inc.’s blockbuster immunology medicine Remicade — [...]
SEOUL, Mar. 11 (Korea Bizwire) — Samsung Group’s pharmaceutical subsidiary Samsung Bioepis will be the third Korean company to manufacture and distribute biosimilar products. The company confirmed that its ‘SB4′ Enbrel biosimilar drug has advanced into regulatory review for manufacturing and marketing by the Ministry of Food and Drug Safety (MFDS), according to an announcement on March [...]