Under the terms of the agreement, JOINN will provide customized process development based on Xbrane ‘s current Xdarzane development program. JOINN will be responsible for further pilot-scale process development, to demonstrate analytical similarity to the originator product and deliver a commercially viable process yield.

Xbrane will lead global out-licensing activities to commercial partners after which subsequent development steps will be taken by Xbrane and JOINN, including additional development, scale-up, clinical development, regulatory filing and commercial manufacturing. The structure enables Xbrane to advance the Xdarzane program without additional direct development investments from Xbrane at this stage.

The collaboration leverages the complementary strengths of both parties: Xbrane’s extensive expertise in biosimilar development, regulatory execution and commercialization partnerships, and JOINN’s integrated biologics development and manufacturing service capabilities, the companies state.

“This collaboration with JOINN represents an important strategic step for Xbrane as we continue to expand our biosimilar pipeline targeting large global biologics markets. Daratumumab is a highly important oncology biologic with significant future biosimilar potential, and we believe the combination of JOINN’s strong CMC and manufacturing capabilities together with Xbrane’s regulatory and partnering expertise creates a highly competitive platform for global development and commercialization,” says Martin Åmark, CEO of Xbrane Biopharma.

“We are proud to have supported the formation of this strategic collaboration between Xbrane and JOINN. The partnership brings together highly complementary capabilities across development, manufacturing, regulatory execution and commercialization, creating a strong foundation for the successful development of a daratumumab biosimilar program,” says Jonas Mortensen, CEO of BioBridge Solutions, which facilitated the partnership between the parties.