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

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- 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.

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

• Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
• Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue FYLNETRA in patients with ARDS.
• Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving FYLNETRA. Discontinue FYLNETRA if sickle cell crisis occurs.
• Serious allergic reactions, including anaphylaxis: Permanently discontinue FYLNETRA in patients with serious allergic reactions.
• Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on FYLNETRA. Consider dose-reduction or interruption of FYLNETRA in patients with kidney injury.
• Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.
• Capillary leak syndrome has been reported after G-CSF administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration.
• The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.
• Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using FYLNETRA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Aortitis has been reported in patients receiving pegfilgrastim products.
• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes.

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 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.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including bank failures; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230516005033/en/