Drugmakers in South Korea are moving in to take market share from GlaxoSmithKline, which saw its prostatic hyperplasia and hair loss medication treatment Avodart (dutasteride) go completely off-patent.
South Korea's top two biosimilar makers are shaking up the global market with recent approvals for lower-cost biologics in Europe and a pending approval for another in the United States.
South Korea's Samsung Bioepis won European Commission approval for commercial sales of a biosimilar of Amgen's Enbrel, marking a first that will make its version of the rheumatoid arthritis treatment available across the European Union as well as Norway, Iceland and Liechtenstein.
Christmas was kind to South Korea's SK Chemicals after government officials on Christmas Eve approved the company's quadrivalent influenza vaccine, which can act against four types of flu with one inoculation. The approval was notable because the approved vaccine was made using the cell-culture method for the first time, according to the country's Ministry of Food and Drug Safety.
Samsung Group's pharmaceutical division appears to be betting the farm on a plan to be the go-to guy when it comes to actually making biosimilar drugs, eschewing contract research and becoming the leading contract manufacturer of them.
Hanmi Science and biosimilar maker Celltrion in South Korea are being touted as leading the charge for the country's pharma sector to be the next engine of growth.
South Korean electronics giant Samsung got into biologics production with the boast that its manufacturing expertise would allow it to produce products at half the cost of Western drugmakers. It is backing that up with plans for a new plant it says will make it the largest biologics contract manufacturer in the world.
South Korea's Samsung BioLogics said last week it will spend at least $736 million to build a new manufacturing plant in Songdo, South Korea, that will have a 180,000-liter capacity when it's completed in 2018.
Shanghai-based ZAI Lab has in-licensed China rights for HM61713, a tumor-targeting EGFR tyrosine kinase inhibitor from South Korea's Hanmi, which has racked up an impressive string of license deals this year.
South Korea's Samsung Bioepis said its biosimilar drug Benepali, used in the treatment of rheumatoid arthritis and other autoimmune diseases, has received a "positive opinion" from the European Medicines Agency's Committee for Medicinal Products for Human Use.