- Bora Biologics will manufacture NYPOZI™ (biosimilar to Neupogen®) at its FDA-registered San Diego site.
- The agreement with InvaGen Pharmaceuticals marks the first FDA-approved biosimilar from a Taiwanese biopharma company to be launched in the U.S.
Bora Biologics, a contract development and manufacturing organisation (CDMO) focused on biologics, has signed a partnership with InvaGen Pharmaceuticals Inc., a subsidiary of Cipla Limited, for the production of NYPOZI™. The therapy, a biosimilar to Neupogen®, will be manufactured at Bora’s FDA-registered facility in San Diego, California.
The collaboration is notable as NYPOZI™ is expected to be the first FDA-approved biosimilar developed by a Taiwanese biopharma company to enter the U.S. market. Bora Biologics will use its commercial manufacturing capabilities to support the product’s launch. Bora’s San Diego facility is equipped with advanced technology and GMP systems designed to deliver 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.”
Stephen Lam, CEO of Bora Biologics
Marc Falkin, CEO of Cipla North America, added that the collaboration represents an important step in Cipla’s U.S. biosimilars strategy and aligns with the company’s commitment to broadening access to affordable treatments.
Looking ahead, Bora Biologics plans to expand its GMP capacity further, with two new 2000L bioreactors for biologics manufacturing scheduled to open in early 2026.
