Tanvex BioPharma USA, Inc., a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, has received U.S. FDA approval for Nypozi (filgrastim-txid), the company’s biosimilar referencing Neupogen,1, to treat chemotherapy-induced neutropenia in cancer patients. The approval marks an important regulatory milestone that was quickly complemented by the FDA’s acceptance of the company’s Biologics License Application (BLA) for TX-05, an investigational antineoplastic biologic targeting HER2-positive breast and gastric cancer, a proposed biosimilar to Herceptin,2 (trastuzumab).

“We are incredibly proud of these recent regulatory milestones,” said John Mosack, chief operating officer, Tanvex. “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,1 (filgrastim), was approved for all relevant indications, including chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Neutropenia, a condition characterized by a low count of white blood cells called neutrophils, is a common side effect experienced by cancer patients undergoing chemotherapy treatment. It is estimated that approximately 60,000 to 100,000 cancer patients in the U.S. develop neutropenia each year. Neutropenia can increase the risk of life-threatening infections, as the reduced white blood cell count leaves the body more vulnerable. If left untreated, neutropenia can lead to delays or interruptions in a patient’s cancer treatment, which can negatively impact their overall health outcomes.

By increasing access to effective therapies, the approval of Nypozi has the potential to benefit tens of thousands of individuals in the U.S. who are battling neutropenia as part of their cancer care.

Henry Chen, chairman and CEO of Tanvex, said, “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.”