Samsung Bioepis, the biosimilars joint venture of Korean conglomerate Samsung and Biogen Idec, has forged an agreement with the drug giant Merck to develop and commercialize multiple biosimilars. The companies have agreed to specific biosimilars candidates that they will develop, although they did not disclose how many or which biologics they will seek to produce.

Biosimilars are copies of branded biologics that have lost patent protection. But unlike generic drugs, which are chemically synthesized and identical to the innovator counterparts, because biologics are derived from cells, they will not be truly identical to the product they seek to match.

In the United States, regulators are still determining the approval pathway that biosimilars will need to traverse. Because they are expected to provide savings over high cost branded biologics, healthcare systems are closely watching the market.

Under the agreement, Samsung Bioepis will be responsible for preclinical and clinical development, process development and manufacturing, clinical trials and registration. Merck will be responsible for commercialization.

While the companies did not disclose financial terms of the agreement, they did say Samsung Bioepis will receive an upfront payment from Merck, product supply income, and will be eligible for additional payments associated with pre-specified clinical and regulatory milestones.

“Samsung Bioepis has been building the capabilities needed to develop high-quality biosimilars,” says Christopher Hansung Ko, CEO of Samsung Bioepis. “With this development and commercialization agreement, Samsung takes a significant step toward becoming a major player in the biopharmaceutical industry.”