Korea FDA Mulls Detailed Biosimilar Guidelines To Boost Homegrown Firms
This article was originally published in PharmAsia News
Executive Summary
SEOUL - Sensing big potential for the biosimilars segment, Korea FDA has embarked upon a plan to improve its guidelines on standardization and quality that can eventually enable its homegrown companies to develop a sizeable pipeline of biosimilar products. The agency intends to implement the guidelines in 2011
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SEOUL - Sensing big potential for the biosimilars segment, Korea FDA has embarked upon a plan to improve its guidelines on standardization and quality that can eventually enable its homegrown companies to develop a sizeable pipeline of biosimilar products. The agency intends to implement the guidelines in 2011. Korea has a long list of potential biosimilars manufacturers and includes players like Celltrion, Green Cross, Daewoong Pharmaceutical, Yuhan Corp., Hanhwa, Samsung and LG Life Sciences. In a package of plans for this year, reported to President Lee Myung-bak Dec. 22, KFDA said its 2011 mission includes plans to strengthen the current EU-modeled initial biosimilar guidance, which defines biosimilars as "those products similar in terms of quality, safety and efficacy to already registered, well-established medicinal products" (Also see "Korea FDA Unveils Initial Biosimilar Guidance; Final Guidelines To Be Released In July" - Scrip, 29 Jun, 2009.). "We have decided to provide more specified detailed guidelines for each biosimilar product because they are quite different from other synthetic drugs when it comes to quality, safety and efficacy," a KFDA planning and budget office spokesperson told PharmAsia News. Biobetters Defined KFDA reported to President Lee that it will also disclose a more concrete definition of "biobetters." "Biobetter is classified as an administrative term now, thus we will seek a legal term and framework," the official said. While many local Korean companies are pursuing biosimilars, Green Cross is the most active and perhaps the only local pharma turning its attention to "biobetters" in addition to biosimilars (Also see "Green Cross To Focus On Biobetters As Korean Biosimilar Space Gets Crowded: Bio Korea Conference" - Scrip, 2 Sep, 2010.). KFDA noted it will set up a system to more closely monitor the evaluation and management of off-label drugs for the purpose of safety. "Since we are checking GMP of the companies operating in Korea, we will move to ensure the safety of imported drugs through on-site inspections of the facilities outside Korea, and shipping their products such as drugs, biopharmaceuticals and human tissues to Korea," the KFDA official said. South Korea has already called for good manufacture practices guidelines on foreign firms producing medical devices sold in Korea (Also see "South Korea To Strengthen Medical Equipment Sector" - Scrip, 26 Nov, 2010.). Cell-Based Therapy Approval And Review Guidelines Sought In light of controversy surrounding the safety of therapies derived from stem cells, KFDA said it will preemptively establish approval and review guidelines explaining the characteristics of these therapies while it seeks - by September - to rationalize the scope of required toxicity data and improved procedures for initiating clinical trials. KFDA added it will support the increased availability of cell lines needed for cell-culture-based vaccine production this year. Regarding the Korean-coined u-healthcare sector - or "ubiquitous healthcare" of devices and diagnostics - KFDA said it will prepare approval and evaluation guidelines for the production of u-healthcare medical equipment. As Korean pharmas become more interested in marketing drugs outside Korea, KFDA said it will set up a taskforce that will hammer out guidelines needed for the development of Korean drugs that could be exported to other countries. -Peter Chang ([email protected]) |