The Food and Drug Administration (FDA) has issued an untitled letter to Amgen Inc. for the misbranding of its biological product, Neulasta (pegfilgrastim) injection, for subcutaneous use, resulting from a false or misleading promotional communication.
Amgen Inc. released a promotional communication that makes false or misleading claims and representations about the benefit of Neulasta when administered through the Onpro on-body injector compared to a prefilled syringe. Neulasta is the reference product for all FDA-licensed biosimilar pegfilgrastim products, which are only available as a prefilled syringe.
Amgen’s promotional communication cites an observational study and makes claims and presentations based on that study that create a misleading impression about the benefit of Neulasta by stating that there is a statistically significant higher risk of febrile neutropenia when pegfilgrastim is administered through a prefilled syringe compared to an Onpro on-body injector. FDA determined the claims and presentations are not supported due to multiple limitations of the study’s design and analytic strategy. The promotional communication’s misleading claims and presentations could cause healthcare providers to conclude that pegfilgrastim delivered through the Onpro on-body injector is more effective than pegfilgrastim delivered through a prefilled syringe or that it is more effective than FDA-licensed biosimilar pegfilgrastim products, which are only delivered through a prefilled syringe.
Making false or misleading statements that could undermine confidence in FDA-licensed biosimilar products can potentially slow the progress and uptake of these important therapies. FDA has serious concerns about such statements and their negative impact on public health, including their potential to create misperceptions about the safety and effectiveness of FDA-licensed biosimilars. These concerns were conveyed to industry in a February 3, 2020, joint statement from FDA and the Federal Trade Commission.
Biologic medications, including biosimilars, play a critical role in the treatment of many serious illnesses, such as cancer and autoimmune disorders. Biosimilars are safe and effective FDA-approved biologic medications with the same expected benefits and risks as the reference product. These products also provide patients with access to more medicines and potentially reduce health care costs, similar to what has been seen with generic drugs.
The untitled letter notifies Amgen of FDA’s concerns and provides the company with an opportunity to address them. FDA requests that Amgen cease any violations of the Federal Food, Drug and Cosmetic Act and submit a written response within 15 working from the date of receipt of the letter, addressing the concerns described in the letter.
Neulasta is 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. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Neulasta is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as pegfilgrastim or filgrastim. The prescribing information for Neulasta includes warnings and precautions such as splenic rupture, acute respiratory distress syndrome, serious allergic reactions, allergies to acrylics, use in patients with sickle cell disorders, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulatory effects on malignant cells, myelodysplastic syndrome and acute myeloid leukemia in patients with breast and lung cancer in conjunction with chemotherapy and/or radiotherapy, potential device failures, and aortitis. The most common adverse reactions reported with use of Neulasta include bone pain and pain in extremity.
FDA encourages healthcare providers and consumers to report potentially false or misleading prescription drug promotion to FDA’s Bad Ad program.
FDA also encourages healthcare providers and consumers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program: