As part of efforts to boost the local biopharmaceutical industry and exports, the Ministry of Food and Drug Safety announced Tuesday that it will shorten the review process of biologics for rare and incurable diseases so they can be approved and distributed for sale overseas as quickly as possible.
A biopharmaceutical, simply known as a biologic, is any medical product extracted from or manufactured with biological sources. Examples of biologics include gene therapy, allergenic products, vaccines and blood components.
Currently, there are about 7,000 biological medicines in development around the world. Many of them have the potential to provide new treatments or even cures for diseases that have no or few treatment options, such as immunological disorders, diabetes, HIV, mental health disorders and infectious diseases, according to the Pharmaceutical Research and Manufactures of America.
South Korea has been making continuous efforts to break into the global biopharmaceutical market, aiming to produce a total of nine new biologics that can be distributed worldwide by the year 2020.
Last year, South Korean pharmaceutical companies together earned 9.3 trillion won ($7.7 billion) exporting drug development technologies, seeting a benchmark as the country’s most so far.
Earlier this month, Korean firm Samsung Bioepis announced that their product Benepali — a biosimilar referencing Enbrel, also known as SB4 — for the treatment of rheumatoid arthritis, had been approved by the European Commission.
Also earlier this month, Korean firm Chong Kun Dang Pharmaceutical signed a technology licensing agreement with Japan’s Fuji Pharma Co. for its second-generation biosimilar named “CKD-11101” for anemia. Based on the agreement, Fuji has agreed to exclusively supply the drug in Japan after clinical trials.
On top of shortening the review period for biologics for rare and incurable diseases, the KFDS said it will provide government consultations for firms that are developing cell therapy products, vaccines and new biosimilars on ways to export their products efficiently and successfully.
To reach its goal to come up with nine new biologics to be manufactured and distributed globally, the government is currently reviewing a total of 75 projects that can treat diabetes and high blood pressure, among others.
The KFDS also announced deregulation measures for the nation’s cosmetics industry, including a plan to establish a regulation-free complex for cosmetics products in Osong, North Chungcheong Province. Within the zones of this complex, cosmetics makers will be allowed to develop products and perform experiments with eased regulations, the officials said.
“In the regulation-free complex, cosmetics sellers who have not registered themselves as manufacturers will be allowed to produce and sell their products,” said Lee Seong-min from the KFDS.
The officials, however, did not offer details on how to control the operation or what exact type of cosmetic companies would be able to join the complex.
The measures also included allowing cosmetics firms to run hair salons and other beauty services.
Also, moisturizers and creams that specifically target individuals who have atopic diseases will now be allowed to be manufactured and sold. Previously, cosmetics products were not allowed to indicate that they were for individuals with atopic diseases unless they were medicines produced by approved pharmaceutical companies.
According to KFDS, South Korean cosmetics companies together made 1.9 trillion won by exporting their products overseas in 2014, up from 290 billion won in 2005.