FDA Approves Second Biosimilar Since Releasing Labeling Guidance, Despite Patent Protection, Safety Concerns

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Ongoing litigation over patent protection and concern about drug labeling guidance and potential patient safety issues have slowed the availability of FDA-approved biosimilars.
Ongoing litigation over patent protection and concern about drug labeling guidance and potential patient safety issues have slowed the availability of FDA-approved biosimilars.

The U.S. Food and Drug Administration (FDA) approved the second biosimilar since issuing its draft labeling guidelines for these novel, complex drugs in late March—despite ongoing concerns about patent protection and patient safety.1

This biosimilar, infliximab-dyyb (Inflectra), is a potentially lower-cost alternative to Johnson & Johnson's brand-name biologic, infliximab (Remicade), for treating several illnesses, including Crohn's disease, rheumatoid arthritis, and ulcerative colitis. The FDA approved the first biosimilar, filgrastim-sndz (Zarxio), in 2015 as a competitor to Amgen's filgrastim (Neupogen) for preventing infections in patients with cancer undergoing chemotherapy.2

Unlike generic drugs—which are synthesized from chemicals and more easily replicated—biosimilars are created from living organisms.3 Because they approximate the original biologic, known as the reference innovator product, biosimilars are not considered identical, only similar.

The hope is that once biosimilars become readily available, they will provide better access and less-expensive alternatives for millions of patients taking high-priced biologics to help cure or manage their disease.4

How rapidly biosimilars enter the marketplace, however, depends, in part, on the outcome of ongoing litigation between the biosimilar and brand-name drug manufacturers over patent protection.5 Sandoz, the generic arm of Novartis and the manufacturer of filgrastim-sndz, filed a petition with the US Supreme Court in February to overturn a lower court ruling that would delay marketing of biosimilars for 6 months beyond an FDA approval.6

Sandoz did not comment on the status of its appeal, but in a written response, the company indicated that it considered the added delay a violation of the original intent of the Biologics Price Competition and Innovation Act, which was signed into law under the Affordable Care Act in 2010.7

Another slow down in the availability of biosimilars is pushback from some health care providers and patient advocates on the FDA's proposed labeling guidelines, citing safety concerns for patients.

“The concept of having new versions of older drugs is a great one,” Howard McLeod, PharmD, FCCP, medical director of the DeBartolo Family Personalized Medical Institute at Moffitt Cancer Center in Tampa, FL, told Cancer Therapy Advisor. “What's difficult is knowing whether what's similar is truly equal.”

Dr McLeod said that although biosimilar copies of supportive-care drugs, such as filgrastim-sndz, are less of an issue, efficacy is paramount when the main drug is part of curative therapy, such as Genentech's rituximab (Rituxan) for lymphoma or the company's trastuzumab (Herceptin) for breast cancer.

“Are the financial savings in this setting worth it to the patient?” he asked. “Right now, it's all theoretical.”

RELATED: Biosimilar LA-EP2006 and Pegfilgrastim Equivalent in Efficacy, Safety in Prevention of Neutropenia in Breast Cancer

David Charles, MD, chairman of the Alliance for Patient Access in Washington, DC, agreed.

Emphasizing the revolutionary role of biologics in health care since their introduction in the 1980s, Dr Charles said that biosimilars have a key difference. “They're definitely not generics,” or near-perfect copies of the biologics they hope to replace, he told Cancer Therapy Advisor. And, for physicians, even that slight difference in formulation heightens concerns about patient safety.

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