{"id":44420,"date":"2022-05-27T12:01:26","date_gmt":"2022-05-27T10:01:26","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/amneal-achieves-third-u-s-biosimilar-approval-with-fylnetra-pegfilgrastim-pbbk\/"},"modified":"2022-05-27T12:01:26","modified_gmt":"2022-05-27T10:01:26","slug":"amneal-achieves-third-u-s-biosimilar-approval-with-fylnetra-pegfilgrastim-pbbk","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/amneal-achieves-third-u-s-biosimilar-approval-with-fylnetra-pegfilgrastim-pbbk\/","title":{"rendered":"Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA\u2122 (pegfilgrastim-pbbk)"},"content":{"rendered":"
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\n– Marks Amneal\u2019s third biosimilar approval in 2022<\/i>\n<\/p>\n

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BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (\u201cAmneal\u201d or the \u201cCompany\u201d) today announced that the U.S. Food and Drug Administration (\u201cFDA\u201d) has approved the Company\u2019s Biologics License Application (\u201cBLA\u201d) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta\u00ae<\/sup>. The product will be marketed under the proprietary name FYLNETRA\u2122.\n<\/p>\n

\nFYLNETRA was developed in collaboration with Kashiv Biosciences, LLC, located in Chicago, Illinois. It is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which is commonly experienced by patients undergoing chemotherapy.\n<\/p>\n

\nThis marks the third biosimilar approval Amneal received this year for products used in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Amneal received approval of Releuko\u00ae <\/sup>(filgrastim-ayow), a filgrastim biosimilar referencing Neupogen\u00ae<\/sup>, and Alymsys\u00ae<\/sup> (bevacizumab-maly), a bevacizumab biosimilar referencing Avastin\u00ae<\/sup>. Amneal expects to launch these three products over the second half of 2022, along with a full patient support program.\n<\/p>\n

\n\u201cThis is our third U.S. biosimilar approval this year and we are very enthusiastic about our future in the fast growing $28 billion U.S. biosimilars market. Biosimilars represent the next wave of affordable medicines and are closely aligned with our mission to provide high quality, affordable medicines to as many patients as possible,\u201d said Chirag and Chintu Patel, Co-Chief Executive Officers.\n<\/p>\n

\n\u201cBuilding on our successful partnership with the recent approval of our first biosimilar, Releuko, we are pleased to receive approval for our second biosimilar. Kashiv is one of a few domestic companies to manufacture and launch multiple biosimilars in the United States. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years. I would like to extend a humble thank you to our highly talented team, without whom this would not have been possible,\u201d said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.\n<\/p>\n

\nAccording to IQVIA\u00ae<\/sup>, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.\n<\/p>\n

\nIndications: <\/b>FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.\n<\/p>\n

\nLimitations of Use<\/b>: FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.\n<\/p>\n

\nFYLNETRA IMPORTANT SAFETY INFORMATION<\/b>\n<\/p>\n

\nFYLENTRA is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.\n<\/p>\n

\nBefore you take FYLNETRA, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.\n<\/p>\n

\nWARNINGS AND PRECAUTIONS<\/b>\n<\/p>\n