FDA approves Nyvepria, a cancer biosimilar similar to Neulasta

Read: FDA approval is based on a review of the comprehensive packet and all the evidence that Nyvepria has a high similarity to reference products
compiling thePfizer (NYSE: PFE) today (NYSE: PFE) announced today (June 11 local time) that the U.SFood and Drug Administration (FDA) has approved Nevepri, a generic drug similar to Theneud ®Patients with non-myeloid malignant tumors received bone marrow inhibitory anticancer drugs associated with the clinical incidence of hyperthermal neutrophil reduction, which was an infection shown by hyperthermal neutrophilotic disease"FDA approval of Nyvepria is a positive step that saves money and increases access to important treatment options," said Andy Schmeltz, global president of oncology atPfizer"We are proud to be able to add this new, long-acting support treatment option to our strong portfolio and now have six FDA-approved biosimilars of oncology, three of which are specifically approved for supportive treatment for cancer patientswe look forward to providing Nyvepria to U.Spatients and doctors later this yearThe approvalFDA is based on a review of the consolidated packets and all the evidence that Nyvepria is highly similar to the reference product"Chemical therapy-induced febrile neutrophil reduction is a relatively common and serious side effect of some cancer treatments, can cause significant complications and may lead to changes in treatment options," said Ali McBride, former president of PharmD, MS, BCPS, BCOPCommunity Cancer Centreassociation (ACCC)"Nyvepria's FDA approval provides clinicians with additional long-acting treatment options that can help prevent infection in patients undergoing bone marrow-suppressive chemotherapy"
biosimilars play an important role in cancer treatment or as a supportive treatment, helping patients increase access to essential medicines and providing value to the health care system by driving market competition and reducing medical costsPfizer has more than a decade of global market experience, nine approved biosimilar portfolios in the United States and the broadest portfolio of biosimilars in oncology-supported treatment, and Pfizer is proud to be a global leader in biosimilars and a leader in this vital healthcare sectorPfizer has also submitted a regulatory approval to the European Medicines Agency (EMA) for a candidate for biosimilars of pyridine, which is currently under reviewPfizer is committed to ensuring that patients who prescribe Nyvepria have access to the treatmentOnce available, U.Spatients will have access to Pfizer Oncology ™, which provides personalized support and financial assistance resources to help patients use prescription Pfizer Oncology drugsPfizer Oncology can help patients understand their benefits and link them to financial assistance resources, regardless of their coverage