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FDA panel casts ‘historic’ vote in support of biosimilar filgrastim
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The decision by the FDA’s Oncologic Drugs Advisory Committee to unanimously recommend approval of the investigational biosimilar filgrastim signaled a seismic shift in the development of cancer drugs.
The committee voted 14-0 on Jan. 7 to recommend approval of the agent, which promotes white-cell recovery after treatments that can trigger neutropenia. Although the FDA is not obligated to follow the advisory committee’s recommendation, it often does so, meaning the stage is set for the first approval of a biosimilar agent in the United States.
“We knew coming in that this vote was going to be historic,” Kimberly L. Blackwell, MD, professor of medicine and assistant professor of radiation oncology in the department of medicine at Duke University, told HemOnc Today. “Not only did we get a positive vote and a clear strategy of what it takes to get a biosimilar approved, but there is such a common goal nowadays to get them developed.”
Kimberly L. Blackwell
Blackwell — an investigator on the PIONEER study, which evaluated the biosimilar filgrastim in patients with breast cancer — said approval of biosimilars would have far-reaching consequences.
“[Biosimilars] will benefit patients from the standpoint of cost and access,” Blackwell said. “They will benefit the pharmaceutical industry because competition actually drives a market incentive, and they will benefit providers because we will have access to a multitude of similar and equally safe agents that will allow us to have the best options for our patients.”
Sandoz Biopharmaceuticals — a subsidiary of Novartis — produces biosimilar filgrastim, which was approved for use in Europe in 2009 and is sold there under the brand name Zarzio.
Sandoz seeks approval of biosimilar filgrastim for all five indications for which its reference product, Neupogen (Amgen), is approved.
The primary indication for Neupogen, a granulocyte colony–stimulating factor, is to decrease incidence of infection — as manifested by febrile neutropenia — in patients with nonmyeloid malignancies who receive myelosuppressive anticancer drugs. It has specific indications for patients with acute myeloid leukemia and patients with cancer who undergo bone marrow transplant. It also is indicated for peripheral blood progenitor cell collection and engraftment, as well as severe chronic neutropenia.
Filgrastim is a biologic agent, an increasingly popular classification of novel drugs that are more complex than chemical drugs. They are typically more expensive than chemical drugs because they can control the market and do not face competition from generic drugs.
The FDA was not permitted to consider approval of less-expensive biosimilars until the passage of the 2010 Patient Protection and Affordable Care Act.
Although biosimilars are not generics because living organisms cannot be copied absolutely, they are nearly identical to the biologic originators. Generics often gain approval without clinical trials, but biosimilars will require some time in trials.
The FDA advisory committee based its decision in part on results of the PIONEER study. The randomized, double-blind, multi-center phase 3 non-inferiority trial compared biosimilar filgrastim vs. Neupogen in patients with breast cancer who underwent treatment with myelosuppressive chemotherapy.
The trial included 218 patients from 27 centers who were divided into one of four groups. Patients in one group received Neupogen only. Patients in a second group received the biosimilar only. Patients in the other two groups received both agents in alternating sequences at the end of each treatment cycle.
Results — presented in December at the ASH Annual Meeting and Exposition in San Francisco and also published in Blood — indicated the efficacy and safety of the biosimilar were comparable to the originator for the prevention of neutropenia. Repeated switching between the two agents had no impact on outcomes, results showed.
“What really moved me was the very strong evidence shown by the sponsor [that demonstrated] the structure, function and ethical performance of [the biosimilar],” advisory committee member Bernard F. Cole, PhD, professor in the department of mathematics and statistics at the University of Vermont, said during the committee meeting.
“This was really the easiest vote for me since I’ve been on the committee,” added Jane Zones, PhD, a retired medical sociologist at the advocacy group Breast Cancer Action in San Francisco and the advisory committee’s consumer representative.
Representatives from several other drug companies attended the advisory committee meeting.
“That demonstrates just how interested people are in what it takes [to garner a recommendation],” Blackwell said.
Louis M. Weiner
Biosimilars have been approved in Europe since 2006, and biosimilars to filgrastim have been approved there since 2008.
Approval of alternatives to the biologics in the United States would increase competition in the marketplace, according to Louis M. Weiner, MD, professor and director of Lombardi Comprehensive Cancer Center at Georgetown University, who was part of the Sandoz presentation to the FDA advisory committee as a paid consultant.
“It is pretty clear that — by increasing the competition — it will likely reduce the costs, as the data from Europe supports that,” Weiner told the committee. “There are criteria that need to be met to treat a patient. There are checkboxes that I thought needed to be checked. In my judgment, they have been checked, and I would feel comfortable prescribing [the biosimilar] to a patient or recommending that it be available to physicians.” – by Anthony SanFilippo
Reference:
Blackwell KL. Blood. 2014;Published online ahead of print Dec. 6.
For more information:
Disclosure: Blackwell served as an investigator on the PIONEER study. She reports a consultant role with Sandoz Biopharmaceuticals.
Perspective
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Mateusz Opyrchal, MD, PhD
The costs of care for patients with cancer have been increasing drastically as new medications to treat cancer, as well as to support patients during chemotherapy, continue coming to the market. Biosimilars will play an important role in providing the highest quality of care for our patients at an acceptable cost to society. The decision by the FDA Oncologic Drugs Advisory Committee to recommend Sandoz’s filgrastim for approval is an important step in the review process of this drug for use in the United States. We look forward to the final FDA decision and having this product available for use for our patients. We hope that resources saved by use of the biosimilar filgrastim will go toward further improvement of care for patients with cancer.Click Here to Manage Email Alerts