Rophibio, a Korean biologics manufacturer, said Wednesday that it has entered into an agreement with Avantor, a U.S. biotech company, to supply raw materials and provide development support for a biosimilar referencing Keytruda.

Keytruda (pembrolizumab) is MSD's blockbuster cancer medicine.

The process development is part of Rophibio's preparations for the future development and IND (investigative new drug) application for a Keytruda biosimilar, the company said.

Rophibio, an affiliate of  healthcare company Amicogen, explained that it has completed developing the biosimilar’s cell line and finished the examination of its next pipeline, adding that process development with Avantor is expected to be completed this year.

In addition to the Keytruda biosimilar, Rophibio has finalized cell line development to produce several other candidates.

According to Rophibio, the company will carefully review the timing of product launches depending on the internal and external environment, including patent expirations for each pipeline, patent barriers from originator pharmaceutical companies, and competitors' development progress.

The company added that it also has completed IND applications in the U.S., Europe, and Korea for the Eylea biosimilar.

"The agreement with Avantor is a strategy to maintain stable profitability in line with the biosimilar life cycle," Rophibio CEO Hong Seung-seo said. "To enhance synergies within the Amicogen Group, we are developing optimized culturing media with Amicogen's affiliate BeyondCell and preparing to develop resin with Puriogen. This is expected to complete the vertical integration of the Amicogen Group's strategy across the bio industry."

Copyright © KBR Unauthorized reproduction, redistribution prohibited