SEOUL - "Celltrion is currently developing a total of nine blockbuster antibody therapeutic biosimilars, and we are preparing for the launch of three biosimilars for markets not protected with patent rights," Kim Yong-Joong, Celltrion's strategic planning assistant manager, told PharmAsia News.

The three products are biosimilars of Roche's oncology agent Herceptin (trastuzumab), Johnson & Johnson's rheumatoid arthritis agent Remicade (infliximab) and Imclone and Bristol-Myers Squibb's oncology agent Erbitux (cetuximab).

Kim said the six others in Celltrion's pipeline are being discussed and developed inside the company as it tries to reshape itself as a global pharmaceutical company producing its own products.

Up until now, Celltrion's main business has been manufacturing products for others. At present, it is manufacturing Bristol-Myers Squibb's RA product Orencia (abatacept) and gearing up to manufacture products for Australia's CSL and Sanofi-Aventis.

"What we are trying to do is to license out our sales rights or copyrights on the three biosimilars to pharmas in 14 developing country regions including China, India and South America under what we call a multinational pool center system," Kim said. "Our basic outline is that we provide the pharmas in the regions with sales rights for our biosimilars, so that they can sell our biosimilars [to be produced in South Korea] in their countries."

The 14 regions include China, the Middle East, India, Taiwan, Turkey and Brazil. Celltrion has already signed agreements with seven regions including China, Taiwan, Venezuela, Peru and others in South America.

Details on how companies would cooperate with Celltrion under the "pool center system" will be discussed and mapped out in the future, said Kim, adding that it could be similar to the "guilds" in the Middle Ages in Europe.

"For instance, we could sell one year's worth of biosimilar sales or copyrights on our biosimilars to the pharmas in the 14 regions, and we receive their products such as pills in return. This could help both benefit each other through synergy effects," said Kim, adding that creation of the pool system could help South Korea stand at the center of the global biopharmaceutical industry.

On May 27, Celltrion signed two deals with Venezuela's Oli Med to give the latter sales rights on Celltrion's nine biosimilar products in the country and 10 other nearby countries in the region for 10 years.

Celltrion also signed a similar deal - on June 22 - with Abdi Ibrahim of Turkey to give the latter sales rights on Celltrion's biosimilar products. Celltrion said the deal with the Turkish company paved the way for potential inroads into European markets in the future.

Unlike developing countries that are not capable of producing their own biosimilars because of the huge investment cost, Kim noted that Celltrion is planning to sell its biosimilars directly in advanced countries such as the U.S. and Europe through its own sales network since those countries have the capability to produce their own biosimilars.

In addition to the 14 regions, Celltrion hopes other big pharmas in developed countries will also want to participate in the "pool guild system," which will be the first of its kind in the global pharma industry.

In line with its global ambition, Celltrion recently signed agreements with China's Shenzhen Main Luck Pharmaceuticals and Taiwan's China Chemical & Pharmaceutical to introduce its oncology biosimilars into China and Taiwan.

A generic trastuzumab, to be launched within two years, for instance, will be more effective than existing products and will be provided at half the price of Roche's Herceptin, said Kim, adding that Celltrion has been looking for opportunities in the fast-growing and immense Chinese market.

"The agreements with the two companies will help Celltrion to establish a bridgehead needed to advance into fast-developing China and Taiwan with our biosimilar products," said Kim, adding that Celltrion will supply the biosimilar product to the two companies in "validation batches," which means they will comply with international GMP standards.

Kim said Celltrion's biosimilar of Roche's Herceptin could help China fight breast cancer, which has been on the rise with roughly 200,000 new breast cancer patients reported each year

In South Korea, Celltrion has been tightening its base. It recently submitted an IND to Korea FDA to begin clinical trials of its Herceptin biosimilar. The company conducted preclinical trials in Europe in monkeys from October to June, which showed equivalent efficacy compared with Roche's Herceptin. Celltrion said it will soon file INDs to conduct clinical trials in Europe and other countries.

South Korean companies are also ramping up to establish a stronghold in the biosimilar sector. Beside Celltrion, local companies include Greencross, Daewoong Pharmaceutical, Yuhan, Hanhwa, Samsung and LG Life Sciences. (Also see "Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules" - Scrip, 21 May, 2009.)

South Korea's FDA is putting the final touches on its EU-modeled initial guidelines for approval and registration of biosimilar products, and anticipates releasing a final version by the end of July (Also see "Korea FDA Unveils Initial Biosimilar Guidance; Final Guidelines To Be Released In July" - Scrip, 29 June, 2009.).

- Peter Chang (p.chang@elsevier.com)

Korean Celltrion Gears Up To Produce Biosimilar Herceptin, Remicade, Erbitux; Proposes Barter System In Developing Regions

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