The banners at CPhI Korea this week in Seoul described the country as a “pharmaceutical powerhouse of the future.”
But while other parts of Asia have established themselves as major hubs of small molecule active pharmaceutical ingredient (API) and finished formulations, Korea’s future has been built on biologics, said YeonJung Lee, Principal Researcher of general affairs at Korea Biomedicine Industry Association (KoBIA) – a private institution which supports the country’s biopharma industry.
The country has seen a 9% compound annual growth rate of domestic biopharmaceutical production for the last five years, while for exports this has been almost 34%, growing from $589m to $809m from 2014 and 2015, led by stem cells and biosimilar products, she told this publication.
“Korea was the first country to approve a stem cell therapy [Pharmicell’s Heartcellgram] and has approved and produced four of the six stem cell therapies approved in global markets.”
These are Medipost’s allogeneic osteoarthritis drug Cartistem, Anterogen’s Cupistem for Crohn’s fistula, and Corestem’s Neuronata-R for Lou Gehrig’s disease.
Biosimilars
And the country has also become a major player in biosimilar manufacturing, she continued, with Remsima, Celltrion’s version of J&J’s topselling biologic Remicade (infliximab), approved in over 70 countries – including the US – and Samsung Bioepis’ Benepali already challenging Amgen’s Enbrel (etanercept) in Europe.
Celltrion has six other biosimilars in its pipeline, Samsung Bioepis five, but Korea is also home to a number of other biosimilar developers, including LG Life Sciences and BIO C&D - which are developing versions of AbbVie’s Humira (adalimumab) - Dong-A Socio, Schnell, Chongkeudang and Daewoong.
Furthermore, Korea has secured major biomanufacturing capabilities, which KoBIA told us will be “the world’s best level” by 2019. This will be led by Celltrion and Samsung Biologics, which will have a combined bioreactor capacity of 670,000L following planned expansions at their respective sites in Incheon.
And Biopharma-Reporter.com is visiting both these manufacturers as part of its visit to Korea, so expect some follow-up reports soon.