Korean pharma, biotech and medical device names are stepping up their inroads into the traditionally-strong Western markets.

Big names like SK Biopharmaceutical and Celltrion, as well as smaller test kit developers such as PCL, Sugentech, and Kogene Biotech are challenging Western giants on their home turf.

Late last month, SK Biopharma’s epilepsy drug cenobamate received approval recommendation from the EMA’s human medicines committee (CHMP). Considering the European Commission’s final approval is usually made within 67 days after CHMP recommendation, the local sale of the drug is expected to begin in the second quarter. SK Biopharm said it will launch cenobamate across Europe through its partner Angelini Pharma under the brand name of Ontozry, adding Angelini Pharma is targeting key European markets based on its network of 15 local operations in 70 countries.

According to SK Biopharm, when cenobamate is approved in Europe, it can receive milestone payments of up to $430 million from Angelini Pharma besides a royalty on future sales.

Celltrion obtained marketing authorization for Remsima SC, a subcutaneous version of its autoimmune disease biosimilar, from Health Canada at the end of last month. Celltrion is expected to use the regulatory approval of Remsima SC as an opportunity to further advance into North America. The company established Celltrion Healthcare Canada in June 2019 to sell Remsima SC directly through its own network.

Korea’s major test kit developers are increasing their market share in advanced healthcare markets beyond the Middle East, South America, and Southeast Asia. Demand for coronavirus test kits are on the rise again around advanced countries as they are necessary to ensure fast vaccination and identify immune responses.

Sugentech recently received European certification for its Covid-19 neutralizing antibody test kit. The neutralizing antibody quantitative test kit can quickly determine the effect of vaccination.

On Jan. 27, PCL completed the registration of its self-test kit of Covid-19 antigens in Austria. The company expects the launch of its self-test kits in Austria to make it easier to enter Germany, Portugal, Spain and Britain where pharmacy tests for the virus are allowed.

Kogene Biotech, whose Covid-19 and influenza A+B combo test kit was recently approved, said it is developing a new test kit for Covid-19 mutants from Britain and South Africa with an aim of commercial launches overseas within the first half of this year.

By Kim Si-gyun and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]