SEOUL - South Korea's FDA is getting ready to release - possibly by the end of May - 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 drive to set up a regulatory framework for the new breed of follow-on biologics.

In working out the framework, KFDA has held 10 rounds of meetings with government officials, specialists and local pharmaceutical officials since April 2008. KFDA hopes to draft final guidelines by the end of June, after receiving industry comments on the initial rules.

"Our guidelines will be largely in accord with the guidelines already released, or to be released in other countries soon, as we target European and Southeast Asian markets," Nam Kyung-Tak, a scientific officer at KFDA's Biopharmaceutical Policy Division, told PharmAsia News. "Since Europe is the only area that is armed with a legal basis for biosimilars, we are trying to trace the EU guidelines."

In line with EU definitions on the subject, Nam said, the Korean guidelines will define biosimilars as "those products similar in terms of quality, safety and efficacy to already registered, well-established medicinal products."

Since April 2007, Nam said, South Korea has joined World Health Organization efforts on the preparation of biosimilar guidelines by participating in meetings with the U.S., Europe, Japan, China and India. The third round of WHO meetings on biosimilars was held in Seoul in May 2008.

Biosimilars are similar, but not identical, to the innovative products on which they are based. Like generic pharmaceuticals, biosimilars are offered at discounted prices to patients.

"Our initial guidelines are expected to be approved by the local pharmas and industry professionals without much change because they have already been discussed and mapped out during more than 10 rounds of consultations between KFDA and local pharma officials so far," said Nam. He added that his regulatory organization hopes to implement the guidelines beginning June 30.

In a sign of growing government and public interest in biosimilars, the Ministry for Knowledge Economy - for the first time - added biosimilars to its extra annual budget expenditures for the biopharma industry for this year.

Kim Sung-Su, a deputy director at the MKE, told PharmAsia News that his ministry has garnered a total of KRW 30 billion ($24.1 million) in additional budget spending for the biopharma industry this year.

"For the first time, biosimilars are included in our ministry's extra spending for the biopharma sector as we expect the biosimilar sector to help move local pharmas' traditional and typical local market [of generics] to foreign markets," Kim said. "We expect large pharmas to focus biosimilars on big markets of the U.S. and EU, while small pharmas [focus] on Asian countries such as China and India."

Noting that expanded budgetary spending on the biopharma sector is in line with President Lee Myung-bak's drive to further bolster the pharma industry over the next decade, Kim said local pharmas should cultivate biosimilars for future growth potential to strengthen their overall global competitiveness (Also see "Korea Targets Biologics, Devices, Health Care Among Economic Growth Projects For Next Decade" - Scrip, 16 January, 2009.).

But Jung Cheol-Won, a spokesman for the Korea Pharmaceutical Manufacturers Association, was skeptical, saying he did not think biosimilars would give local pharmas a competitive edge because global biosimilar guidelines, including the Korean version, could make production and trials of biosimilar products much more expensive for South Korean companies.

He expects trials and manufacturing of biosimilar products to be much more complex than traditional generics.

"Unlike synthetic generics, on which Korean pharmas are largely dependent now, biosimilars are much more complicated, and I am not sure whether bioequivalence, which compares generics to the original products, could also be applied to biosimilars," Jung said. "But one thing is clear - local pharmas are gearing up for biosimilars as they want to be early starters in the new pharma sector."

Although they know they will face huge costs for production and trials of biosimilars, several South Korean companies are steadily moving to grab a solid position in the biosimilar sector, Jung said. These companies include Celltrion, Greencross Corp., Daewoong Pharmaceutical, Yuhan Corp., Hanhwa, Samsung and LG Group.

LG Life Sciences completed Phase III clinical trials in March of its biosimilar slow-release recombinant human growth hormone somatropin weekly injection for treating adults with growth hormone deficiency. The company expects to submit a biologics license application to regulators by year end (PharmAsia News, March 27, 2009).

- Peter Chang (pharmasia@elsevier.com)

Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules

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