'Herceptin', biosimilars(follow-on biologics) was applied for its clinical trials(IND) to the European Union(EU) by CELLTRION PHARM(Local bio-pharmaceutical company) for the first time in the world.

'Herceptin'(anti-breastcancer) had been developed by Genetic Engineering Technology, Inc. which was the greatest biotechnology corporation in the world. it is a blockbuster drug of which annual sales recorded $5000 billion last year.

Actually, the Swiss pharmaceutical conglomerate Roche completely owns Genentech after its purchase on 26 March 2009 for approximately $46.8 billion.

CELLTRION PHARM plans to complete the application for the Herceptin's clinical trials to the EU's 14 nations by end of October and to start clinical trials just after receiving approval from it.

An official of CELLTRION PHARM said, "To meet the European Medicines Agency (EMEA)'s guidelines, we prepared a plan for development of production methods and clinical trials. In fact, until now the EMEA has approved the application according to its guidelines."

The EMEA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products. Under the centralised procedure, companies submit a single marketing authorisation application to the EMEA.

Once granted by the European Commission, a centralised (or ‘Community’) marketing authorisation is valid in all EU and Iceland, Liechtenstein and Norway.

SCHNeLL Korea, a bio-pharmaceutical company is also preparing for the clinical trials of biosimilars. [헬스코리아뉴스]

▶ 한국슈넬제약 등 바이오복제약 개발 팔 걷었다

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