Korea Food and Drug Administration (KFDA) was set up in April 1996 and as a country policy, they are trying to support all biopharmaceutical companies in the country.
Celltrion, a South Korean company, was established in 2002 with a goal to be the world’s leading biopharmaceutical company in the Asian region1. They are dealing with development of biosimilars, development of new biologics and also contract manufacturing for biologic drugs.
After the foundation of Celltrion Inc., the company has built its first facility of a 50,000 L capacity in Seoul and began to sign supply agreements with multinational companies.
The second facility, which has a capacity of 90,000 L is then contructed and mechanical completion was finished at the end of 2010.
According to Stanley Hong, the Head of R&D at Celltrion, Korean FDA is very supportive to approve biosimilars if the companies meet the local guidelines. KFDA is helpful for the industries to try to reduce the development and approval timelines for biosimilars to 3-4 years Mr. Hong added in his presentation which was made in Berlin, Germany this year.
Although Celltrion is not a pioneer in biosimilars area, they will probably be the pioneer for biosimilar monoclonal antibodies because according to Mr.Hong’s presentation, Celltrion has the most impressive pipeline for biosimilar monoclonal antibodies.
Celltrion is trying to develop several products including rituximab, trastuzumab, infliximab biosimilars which are already blockbusters in the world pharmaceuticals market and their patents are soon to be expired in the EU and US. Phase III clinical trials are ongoing for Remicade and Herceptin biosimilars and after the completion of the trials, these two products will be launched in the local Korean market rapidly.
Both products will be launched worldwide with the distribution agreements; Celltrion has already signed some agreements with Hospira2, Egis3 and Hikma4 for different parts of the world.
According to Mr.Hong, Celltrion will also be interested in developing biobetters. Additionally, they have their own new product pipeline which makes them an integrated biopharmaceutical company. One of these new projects is being developed in oncology setting and also there are projects for flu and rabies in Celltrion pipeline.
Reference: Hong S. Biosimilar development in Korea and Celltrion; Informa Life Sciences’ Biosimilars Conference; 2011 Jun 9; Berlin, Germany.