Capitalizing on a wealth of biologics expertise, 2010 start-up Coherus BioSciences Inc. is moving into the global biosimilars space, kicking off its efforts with an Asian partnership with Daiichi Sankyo Co. Ltd. to develop and commercialize biosimilar versions of Enbrel (etanercept, Amgen Inc.) and Rituxan (rituximab, Biogen Idec Inc. and Roche AG).

Founded and staffed by an impressive array of biotech veterans – among them are Stuart Builder, co-founder and chair of the scientific advisory board, whose previous experience at Genentech Inc. (now part of Roche) included work on plasminogen activator, the first recombinant human pharmaceutical made by cell culture – Coherus operates a business model aimed at promoting global access to patients.

"We've got a team that was really part of the first wave of [biologic] products," said Denny Lanfear, president, CEO and chairman, whose resume includes a decade at Thousand Oaks, Calif.-based Amgen heading up the process development unit.

"We've been around, and we've seen the whole business move forward," he told BioWorld Today. "Now we see an opportunity to move it forward on a more global basis."

A large part of its strategy involves forming partnerships with high-caliber pharma firms. That's where the deal with Tokyo-based Daiichi comes in.

Terms of that collaboration call for the two firms to work together to develop, manufacture and commercialize the biosimilars for anti-TNF-alpha drug Enbrel for autoimmune disorders and anti-CD20 antibody Rituxan for cancer, Daiichi will have rights to commercialize the products in Japan, South Korea and Taiwan, while Coherus retains development and commercialization rights in the rest of the world. Specific financial terms were not disclosed.

"We're very excited," Lanfear added. "Daiichi is an excellent global pharmaceutical company."

Coherus anticipates additional deals going forward and looks to build a network of partners, including pharma firms, contract manufacturing organizations and contract research organizations. "We see that as the most appropriate way to proceed," he said. Those deals will "provide us with operating leverage and global reach."

The company isn't disclosing much in the way of specifics at this time, but its work will no doubt take advantage of the expertise of its staff in the manufacturing and development of biologics.

For its part, Daiichi is hardly the first pharma firm hoping to make inroads in the biosimilar space. New York-based Pfizer Inc., for instance, has already set up a biosimilars section in its Established Products Business Unit. And, late last year, Weston, Mass.-based Biogen Idec Inc. established a joint venture with Samsung Biologics to develop and market biosimilars. (See BioWorld Today, Dec. 7, 2011.)

Currently, the regulatory path for biosimilars is better established overseas, but the U.S. is coming on board. The FDA earlier this year released the first draft guidances designed to add predictability and transparency to the development and manufacturing process. (See BioWorld Today, Feb. 8, 2012, and Feb. 10, 2012.)