Xbrane Biopharma and AGC Biologics enter into an Agreement to Manufacture Xcimzane™ for Clinical Development
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE), a leading biosimilar developer, and AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), have entered into an agreement to manufacture Xcimzane™, a Cimzia® biosimilar candidate, for clinical development.
Under terms of the agreement, the companies will work together to upscale the established Xcimzane™ manufacturing process and produce several commercial scale batches for upcoming phase I and phase III clinical trials as well as the Comparability Analytical Assessment required for regulatory filing.
“AGC is a high-quality partner with global manufacturing expertise, and we are pleased to enter into this agreement as the next step in the development of Xcimzane™ towards clinical trials” said Martin Åmark, CEO Xbrane Biopharma.
“We are proud to be the partner of choice for this technically demanding biosimilar throughout the whole clinical phase” said Patricio Massera, CEO AGC Biologics.