Bora Biologics, a leading contract development and manufacturing organization (CDMO) specialising in biologics, has partnered with InvaGen Pharmaceuticals, a wholly owned subsidiary of Cipla Ltd., for the manufacture of NYPOZI at its FDA-registered facility in San Diego, California.  This will make NYPOZI the first FDA-approved biosimilar developed by a Taiwanese biopharma company to launch in the US market.

A biosimilar to Amgen's Neupogen (filgrastim), NYPOZ is indicated to decrease the incidence of infection, specifically febrile neutropenia, in patients with non-myeloid malignancies who are receiving myelosuppressive anticancer drugs.

Bora Biologics will leverage its US commercial manufacturing capabilities to support the production of this innovative therapy. Its San Diego facility is equipped with advanced technology and rigorous GMP processes, enabling the efficient manufacture of high-quality biologics.

"We are thrilled to be InvaGen's manufacturing partner for NYPOZI in the United States. Our FDA-registered facility is designed to meet the stringent requirements of biologics manufacturing, and we are dedicated to supporting this product's journey to market, making more affordable medicine available to patients,” said Stephen Lam, CEO of Bora Biologics.

Marc Falkin, CEO, Cipla North America, added, "Our foray into the US biosimilars signals a key milestone for Cipla. This further aligns with our purpose of ‘Caring for Life' by making advanced therapies available to those in need, ultimately enhancing patient outcomes in the US."