Pfizer's Biosimilar Nyvepria (pefegrastim) Is Approved By The US FDA!

- Jun 23, 2020-

Pfizer recently announced that the U.S. Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), which is a biosimilar to Amgen's blockbuster "liter white" brand drug Neulasta (pegfilgrastim). Nyvepria is suitable for reducing the incidence of febrile neutropenia, which is one of the most serious side effects of many types of chemotherapy and can reduce the ability of cancer patients to fight infection.

In July 2018, Pfizer's another biosimilar, Nivestym (filgrastim-aafi), was approved by the US FDA. The drug is a biosimilar of Amgen's "Shengbai" brand drug Neupogen (filgrastim).

FDA approval of Nyvepria is based on a review of a comprehensive data package and all the evidence to prove that Nyvepria is highly similar to the reference product Neulasta. Pfizer has also submitted a marketing application for pegfilgrastim biosimilar to the European Medicines Agency (EMA), which is currently under review.

Andy Schmeltz, Pfizer’s Global President of Oncology, said: “FDA approval of Nyvepria is a positive step that can both save costs and increase access to important treatment options. We are proud to introduce this new, long-term supportive care plan Added to our strong product portfolio, there are now six FDA-approved tumor biosimilars, three of which are specifically approved for supportive care of cancer patients. We look forward to reporting to US patients and doctors later this year Provide Nyvepria."

Ali McBride, former president of the Community Cancer Center Association (ACCC), said: "Fevery neutropenia caused by chemotherapy is a relatively common and serious side effect in some cancer treatments, which may cause serious complications and may lead to treatment options. Changes. The FDA’s approval of Nyvepria will provide clinicians with an additional long-term treatment plan that can help prevent infections in patients with myelosuppressive chemotherapy."

Biosimilars play an important role in cancer treatment or supportive care. It not only helps to increase patients' access to basic medicines, but also promotes market competition, reduces care costs, and provides value to the medical system.

Pfizer has more than a decade of global market experience in biosimilars, with 9 approved biosimilar product portfolios in the United States and the broadest portfolio of biosimilars to support cancer treatment. Pfizer is proud to be a biosimilar Global leader in the field, and in a leading position in this important healthcare field.


pegfilgrastim is a long-acting version of filgrastim (recombinant human granulocyte macrophage colony stimulating factor [G-CSF]), which is modified by polyethylene glycol (PEG) to prolong the metabolic time of the drug in the body and has a better effect. Both drugs are "whitening" drugs, used to increase the number of white blood cells in patients. G-CSF is mainly used for the prevention and treatment of leukopenia caused by tumor radiotherapy or chemotherapy, treatment of bone marrow hematopoietic dysfunction and myelodysplastic syndrome, prevention of potential infection complications of leukopenia, and neutralization caused by infection The recovery of neutropenia is accelerated. After radiotherapy or chemotherapy, tumor patients often have symptoms such as leukopenia and reduced anti-infection ability. Therefore, the clinical use of "whitening drugs" to increase the number of white blood cells in patients.

Neutropenia is one of the most serious side effects of chemotherapy. Studies have shown that in the United States, 4,000 cancer patients die of febrile neutropenia each year, and 60,000 people are hospitalized for neutropenia. In the next 10 years, biosimilars are expected to save up to US$54 billion in the US healthcare system. There is an urgent need for more neutropenia treatment options in this market because of cancer-related neutropenia The annual cost of hospitalization is as high as $2.3 billion.

According to the FDA database of biosimilars, as of now, the agency has approved two filgrastim biosimilars, namely: Nivestym (filgrastim-aafi, July 2018, Pfizer), Zarxio (filgrastim-sndz, 2015 3 Month, Sandoz).

In addition, the FDA has approved four biosimilars of pefigrastim: Nyvepria (pegfilgrastim-apgf, June 2020, Pfizer), Fulphila (pegfilgrastim-jmdb, June 2018, Mylan), Udenyca (pegfilgrastim-cbqv, November 2018, Coherus BioSciences), Ziextenzo (pegfilgrastim-bmez, November 2019, Sandoz).