FDA approves first biosimilar drug


SILVER SPRING, Md. — The Food and Drug Administration announced approval for Zarxio (filgrastim-sndz), the first biosimilar approved in the United States, the agency said. A biosimilar is a biological product — a product generally derived from a living organism, which can include humans, animals and microorganisms — that is approved based on evidence that it’s “highly similar” to an approved biological product (a reference product.)

According to the FDA, the “biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product.” 

Zarxio, which is marketed by Sandoz, is biosimilar to Amgen’s Neupogen (filgrastim), which was first licensed in 1991. Zarxio is approved for the same indications as Neupogen. The FDA stated that it may be prescribed to treat the following:

  • Patients with cancer receiving myelosuppressive chemotherapy;

  • Patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;

  • Patients with cancer undergoing bone marrow transplantation;

  • Patients undergoing autologous peripheral blood progenitor cell collection and therapy; and

  • Patients with severe chronic neutropenia.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA commissioner Margaret Hamburg, M.D. “Patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

A biosimilar can only receive FDA approval if it has the same mechanism of action, method of administration, dosage form and strength as the reference product, the agency stated. The biosimilar also must have the same indication and conditions of use that have been approved for the reference product. Facilities where biosimilars are produced must meet the FDA’s standards as well.

Ralph Neas, president and CEO of the Generic Pharmaceutical Association, released the following statement regarding the FDA's approval:

“Today’s FDA approval of Zarxio (filgrastim-sndz), the first biosimilar medicine in the United States, heralds a new era for cancer patients and the American healthcare system, one where access to safe, affordable versions of lifesaving biologics will finally be a reality. Consumers, employers, private insurers, taxpayers, state governments and federal programs all will benefit from the advent of biosimilars, as intended by the Biologics Price Competition and Innovation Act that was enacted as part of the Affordable Care Act.

The FDA’s approval of Sandoz’s Zarxio (filgrastim-sndz) indicates that the agency has scientifically determined that the medicine is 'highly similar' to, and has 'no clinically meaningful differences' from, the reference product, so that cancer patients in the United States can now rely on the same biosimilar that has been available in Europe for years. Several GPhA member companies have developed, manufactured and are marketing biosimilars around the globe, and there are four other known applications accepted for Agency review at this time.

Dozens of organizations representing consumers, seniors, payers, pharmacists, purchasers, pharmacy benefit managers, labor unions, retail pharmacies, managed care pharmacies and other healthcare stakeholders have long-anticipated this moment. It is deeply gratifying to have our collaborative efforts to educate policymakers and promote access, affordability and competition in the biologics sector, realized today. We congratulate the Agency, Sandoz and most importantly, patients on this historic development.

As the FDA continues its work to implement the BPCIA, we reiterate our stance that the Agency’s departure from the currently accepted international nonproprietary name system could disrupt the ability to track and dispense these medicines, risking provider confusion and patient safety. GPhA and more than 30 health organizations agreethat it is critical to preserve the system already proven to be safe and effective worldwide.”

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