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Kashiv Biosciences Achieves Second U.S. Biosimilar Approval with FYLNETRA® (pegfilgrastim-pbbk)

Marks Kashiv’s second biosimilar approval in 2022

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Kashiv Biosciences, LLC (“Kashiv” or the “Company”) is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved its Biologics License Application (“BLA”) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta®. The product will be marketed under the proprietary name FYLNETRA®.

FYLNETRA was developed by Kashiv in Chicago, Illinois in collaboration with Amneal Pharmaceuticals, Inc. (“Amneal”). 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.

This marks the second biosimilar approval Kashiv received this year for products used in oncology, the second-largest biosimilar category in the U.S. Earlier this year, Kashiv and Amneal received approval of Releuko® (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen®. Kashiv expects both products to launch via its commercial partner, Amneal, over the second half of 2022, along with a full patient support program.

“Building on our successful partnership with Amneal 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. We are excited to build on the momentum as we look towards future approvals to bring high quality biosimilars to the global markets,” said Dr. Chandramauli Rawal, Chief Operating Officer for Kashiv.

“The approval of FYLNETRA® is our third U.S. oncology biosimilar approval in as many months. Amneal is well positioned in the fast growing $28 billion U.S. biosimilars market as we build our portfolio initially through in-licensing and vertical integration over time. We are very enthusiastic about our future in biopharmaceuticals. 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,” said Chirag and Chintu Patel, Co-Chief Executive Officers for Amneal.

According to IQVIA®, 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.

Indications: 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.

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

FYLNETRA IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

Before 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.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

For full prescribing information, see package insert located here.

About Kashiv Biosciences, LLC

Kashiv Biosciences, LLC is a premier, fully integrated biopharmaceutical company developing advanced-stage biosimilars and specialty biopharmaceutical products. The company is headquartered in Piscataway, NJ with facilities in Chicago, IL and India that all together provide formulation development, analytical testing, biosimilar characterization, and manufacturing of small and large molecules.

Contacts

Dr. Chandramauli Rawal

Chief Operating Officer

drcrawal@kashivbio.com

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