FDA’s First Biosimilar Approval Draws Excitement, Concern

Novartis International AG announced this month that the FDA has approved filgrastim-sndz (Zarxio, Sandoz). Sandoz, a Novartis company, is the first company to have received FDA approval of a biosimilar, via the new FDA biosimilars pathway. And this approval, according to a Novartis press release, opens the door for greater access to high-quality biologics in the U.S.

"Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the U.S. for a variety of reasons, including price," Louis Weiner, M.D., chairman of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University, says in the release. "Biosimilars have the potential to increase access and the approval of filgrastim-sndz may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice."

Not everyone is so positive, however. In response to the news, the American Autoimmune Related Diseases Association (AARDA) released this statement: “On behalf of the 50 million Americans living with autoimmune disease, AARDA is concerned that the FDA has approved the first U.S. biosimilar drug without first having published any final standards. The FDA has yet to issue final guidance on a range of issues that will impact patient safety, including interchangeability, naming, and indication extrapolation.”

As biologic therapies reach the end of their patent protection, there must be standards in place for their approval, based on analytical and clinical comparisons to the appropriate biologic product, according to an AARDA press release.

Biosimilars, which can never be identical to the original biologics, are not generic versions, like those for chemically-based drugs, according AARDA.

Although this first approved biosimilar does not have dermatologic applications, dermatologist Marc J. Inglese, M.D., writes in an email to Dermatology Timesthat he agrees with AARDA’s concerns with what appears to be the fast tracking of these medications for approval. He says he is most concerned with issues of interchangeability. 

“It is important for dermatologists and patients to know that biosimilars are not identical to the parent drug as most generic medications are required to be.  There is likely a place for biosimilars in the treatment of our patients once we become comfortable with a particular drug’s use, efficacy and safety,” Dr. Inglese, a clinical assistant professor in dermatology, Florida State University College of Medicine, Tallahassee, Fla.,  writes. “However, there need to be laws and guidelines to protect patients’ access to proven and safe branded biologics, to make sure biosimilars are not substituted without the physician's or patient's knowledge.”