SEOUL - While South Korea's FDA is getting ready to release its initial version of registration guidelines for biosimilars, the Ministry for Knowledge Economy said it would use public funds to help local pharma and biotech companies to compete in the biosimilar arena.

Hoping to have at least three local biosimilars in development by 2012, the ministry said it will use part of the KRW 100 billion ($83.3 million) earmarked for national biotech projects and allocate funds for research and development and capital investment in biosimilars.

"We already promised a government support package of KRW 20 billion for the biopharma industry, and we will draw KRW 80 billion more from other sources including long-term private-public funds for biopharma companies," Kim Sung-Su, a deputy director at the ministry told PharmAsia News. "The government drive is aimed at helping local pharmas to advance into global markets with their competitive biosimilars and generics in coming years."

Kim said his ministry is expanding its support scope for local pharmas and biotech companies under overall government efforts to upgrade South Korea's biosimilar technology to be more on a par with advanced countries by 2011.

The ministry will also cultivate contract research organizations and contract manufacturing organizations so that companies pursuing biosimilars can better bolster their biosimilar R&D capacity, Kim said.

The ministry's initiatives are part of a broader government package that will inject a total of KRW 24.5 trillion ($19.4 billion) in the next five years to develop and strengthen the country's 17 "new growth engine industries" (Also see "Korea Targets Biologics, Devices, Health Care Among Economic Growth Projects For Next Decade" - Scrip, 16 January, 2009.)

In addition to the recent package, Korea Pharmaceutical Manufacturers Association Spokesman Jung Cheol-Won says the government should enact measures to improve the efficiency of clinical trial registration and approval.

"The Korean government wants local pharmas and biotech companies to be front-runners in the global biosimilar market at a time when MNCs or other foreign pharmas aren't sure what to do with biosimilars," Jung said. "Since local pharmas and biotech companies have been doing some research and development work on biosimilars so far, they could be able to enter the biosimilar market more easily than foreign pharmas or MNCs."

Jung said local companies are currently developing biosimilar products. Daewoong Pharmaceutical currently has a biosimilar EPO product on the market for anemia and Celltrion has biosimilar products in development.

With the Korean government's determined push for biosimilars, coupled with slow but steady preparations by local pharma and biotech companies, Jung said, South Korea may be able to lead market share for global biosimilars.

Noting that there are no clear signs yet that MNCs in Seoul are turning their attention to biosimilars, an official with a MNC in Seoul, said that biosimilars are a hot topic that are discussed among both local companies and MNCs.

"It is certain that biosimilars are something both local generic makers and MNCs are interested in, but local Korean generic makers are more interested in [those] emerging products because they have been heavily dependent on generics so far," said the official who asked not to be named. "All recent Korean government discussions and steps are centered on local generic makers, not on MNCs."

However, the official noted big MNCs such as Pfizer, Roche and Novartis might be potential competitors to local generic makers because "no one knows when these big MNCs, along with other MNCs, will jump into the biosimilar market on the belief that biosimilars are also a potentially profitable market for them."

For its part, KFDA is getting ready to release an initial version of guidelines for approval and registration of biosimilars modeled after European Union rules. The guidelines will wrap up KFDA's year-long efforts to set a regulatory framework for follow-on biologics (Also see "Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules" - Scrip, 21 May, 2009.).

- Peter Chang (pharmasia@elsevier.com)

Korean Government Accelerates Support For Homegrown Biosimilars

More from Archive

More from Scrip