Tanvex BioPharma USA Scores Big With Two Major U.S. Regulatory Wins

Tanvex BioPharma USA, Inc., a company specializing in biologics and biosimilars as a contract development and manufacturing organization (CDMO), has secured U.S. FDA approval for Nypozi (filgrastim-txid), its biosimilar to Neupogen, for the treatment of chemotherapy-induced neutropenia in cancer patients. This achievement is a key regulatory success, further highlighted by the FDA's recent acceptance of Tanvex’s Biologics License Application (BLA) for TX-05, a biosimilar candidate to Herceptin (trastuzumab), which is intended for the treatment of HER2-positive breast and gastric cancers.

John Mosack, chief operating officer, Tanvex, said in a statement, “We are incredibly proud of these recent regulatory milestones. They represent a significant step forward for our company, showcasing our dedication to bringing innovative and cost-effective solutions to healthcare via our U.S. based and FDA licensed manufacturing facility. Nypozi will provide an important treatment option for patients, and the acceptance of our TX-05 BLA further demonstrates our continuing commitment to developing and manufacturing high-quality biologics for our clients.”

Nypozi (filgrastim-txid), a biosimilar to Neupogen (filgrastim), has been approved for a range of uses, including the long-term management of severe neutropenia and its complications—such as fever, infections, and mouth ulcers—in patients with conditions like congenital, cyclic, or idiopathic neutropenia. Neutropenia, characterized by a dangerously low level of neutrophils (a type of white blood cell), is a common complication in cancer patients undergoing chemotherapy. 

Each year in the U.S., an estimated 60,000 to 100,000 cancer patients develop neutropenia, significantly raising their risk of serious infections due to their weakened immune systems. If not addressed, neutropenia can lead to treatment delays or interruptions, adversely affecting patients' overall health outcomes. The approval of Nypozi offers a promising option for expanding access to vital treatments, potentially benefiting tens of thousands of cancer patients in the U.S. who face the challenges of neutropenia during their care.

Henry Chen, Chairman and CEO of Tanvex, mentioned, “Our deepest gratitude is offered to the patients and their loved ones for participating in our clinical programs and to Tanvex scientists and collaborators for persevering over many years of development.”