Amneal Launches Third Biosimilar with FYLNETRA™ (pegfilgrastim-pbbk) in the United States

2023-05-17

上市批准生物类似药临床结果

- Third of three approved U.S. oncology biosimilars Amneal has launched

BRIDGEWATER, NJ, USA I Ma 16, 2023 I Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing Neulasta® in a pre-filled single-dose syringe. FYLNETRA™ 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. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois. The J-Code (Q5130) from the Centers for Medicare & Medicaid Services (CMS) for FYLNETRA™ has been approved and is active.

“FYLNETRA marks our third U.S. biosimilar launch since late last year. We are excited to be contributing to this next wave of affordable medicines, and we are well positioned to drive access across patients, providers, and payors. Although it’s only the early innings for the growing biosimilars market, we are focused on becoming a key player over the long-term. These first three launches are just the start for Amneal in biosimilars,” said Harsher Singh, SVP of Amneal Biosciences division.

“We are pleased to launch the FYLNETRA biosimilar. This launch builds on our successful partnership with Amneal and the good uptake we are seeing of the RELEUKO biosimilar, which was launched in the fourth quarter of 2022. Kashiv is one of a few companies based in the United States to manufacture and launch multiple biosimilars. Kashiv aims to continue bringing high quality biosimilars to the global markets over the coming years,” said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

According to IQVIA®, U.S. annual sales for pegfilgrastim for the 12 months ended March 2023 were $2.6 billion, of which $908 million represented biosimilar sales.

About FYLNETRA

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.

FYLNETRA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global essential medicines company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

SOURCE: Amneal Pharmaceuticals

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构