FDA Approves 2 New Biosimilars for Patients with Cancer

Web Exclusives - FDA Updates

Retacrit First Biosimilar to Epogen/Procrit

On May 15, 2018, the FDA approved epoetin alfa-epbx (Retacrit; Pfizer) as the first biosimilar to epo­etin alfa (Epogen, Procrit; Amgen) for the treatment of anemia caused by chronic kidney disease, myelosuppressive chemotherapy, or the use of zidovudine in patients with HIV. The new biosimilar is also approved to reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery.

“It is important for patients to have access to safe, effective and affordable biological products, and we are committed to facilitating the development and approval of biosimilar and interchangeable products,” said Leah Christl, PhD, Director of the Therapeutic Biologics and Biosimilars Staff in the FDA’s Center for Drug Evaluation and Research. “Biosimilars can provide greater access to treatment options for patients, increasing competition and potentially lowering costs.”

The approval of epoetin alfa-epbx was based on a review of evidence, including structural and functional characterization, and data regarding human pharmacokinetics and pharmacodynamics, clinical immunogenicity, animal studies, and clinical safety and efficacy demonstrating that epoetin alfa-epbx is a biosimilar to the reference drug. Epoetin alfa-­epbx is approved as a biosimilar, but is not an interchangeable drug.

Just as with the reference drug, epoetin alfa-epbx includes a boxed warning alerting healthcare providers and patients to the increased risks for death, heart problems, stroke, and tumor growth or recurrence. Additional warnings include hypertension, seizures, aplastic anemia, serious allergic reactions, and severe skin reactions.

Fulphila First Biosimilar to Neulasta

On June 4, 2018, the FDA approved pegfilgrastim-jmdb (Fulphila; Mylan GmbH) as the first biosimilar to pegfilgrastim (Neulasta; Amgen) to reduce the risk for neutropenia in patients who receive myelosuppressive chemotherapy known to be associated with febrile neutropenia.

“Bringing new biosimilars to patients is a top priority for the FDA, and a key part of our efforts to help promote competition that can reduce drug costs and promote access,” said FDA Commissioner Scott Gottlieb, MD. “We’ll continue to prioritize reviews of these products to help ensure that biosimilar medications are brought to the market efficiently and through a process that makes certain that these new medicines meet the FDA’s rigorous standard for approval.”

The approval of pegfilgrastim-jmdb was based on a review of structural and functional characterization and clinical safety and efficacy related to pegfilgrastim-jmdb to demonstrate it is a biosimilar to the reference drug Neulasta.

Like all biosimilars, pegfilgrastim-jmdb is approved as a biosimilar but is not an interchangeable drug.

The most common adverse reactions with pegfilgrastim-jmdb are bone pain and pain in extremities. Patients who have had serious allergic reactions to human granulocyte colony-stimulating factors or filgrastim drugs should not take pegfilgrastim-jmdb.

Commenting on the approval of biosimilars by the FDA, Dr Gottlieb noted, “This summer, we’ll release a comprehensive new plan to advance new policy efforts that promote biosimilar product development. Biologics represent some of the most clinically important, but also costliest products that patients use to promote their health. We want to make sure that the pathway for developing biosimilar versions of approved biologics is efficient and effective, so that patients benefit from competition to existing biologics once lawful intellectual property has lapsed on these products.”

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Last modified: April 27, 2020