You are here

Prescription: Washington

FDA Accepts Its First Biosimilar Application

However, the Agency’s Requirements Are Still Unclear
Stephen Barlas

Sandoz’s announcement that the Food and Drug Administration (FDA) has accepted its application for approval of filgrastim as potentially the first biosimilar drug to be licensed in the U.S. set off one of the periodic fits of attention paid to the absence of biosimilars in the U.S. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was supposed to set off a run by companies seeking FDA approval of biosimilars they already sell in Europe and Asia. That law was passed as an amendment to the Affordable Care Act, which Congress approved in 2010.

But in the ensuing four years, the FDA has not filled in the gaps on some key approval issues, such as how a biosimilar will be named and whether pharmacists need to notify physicians when the pharmacist substitutes a biosimilar for a brand-name biologic. Notification is subject to state laws, but various sectors of the pharmaceutical industry—payers, consumers, pharmacy benefit managers, pharmacists, and brand and generic companies—would probably like to see the FDA, or even Congress, establish a consistent federal requirement on notification. In the absence of that requirement, some states are moving on their own, and not necessarily with similar policies.

Filgrastim would compete in the U.S. with Amgen’s Neupogen, indicated to decrease the incidence of infection in patients being treated for cancer. Under the brand name Zarzio, filgrastim has been marketed in more than 40 countries.

The FDA’s intention to make its first formal biosimilar decision based on the filgrastim application may clear up some of the confusion surrounding biosimilar policy. “This filing acceptance represents a significant step toward making high-quality biologics more accessible in the U.S., and we applaud FDA for its progress in making this a reality,” says Mark McCamish, MD, PhD, Head of Global Biopharmaceutical and Oncology Injectables Development at Sandoz. “As they’ve done in Europe and other highly regulated markets around the world, biosimilars are poised to increase U.S. patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall health care system.”

The announcement of the first biosimilar to enter the FDA pipeline also prompted complaints about the paucity of drugs in the pipeline and a renewed focus on various and in some instances conflicting state legislative actions on biosimilars. In August, two senior U.S. senators wrote to Sylvia Burwell, Secretary of Health and Human Services (the FDA’s parent agency) asking where the guidance was for elements of the BPCIA.1 They noted the agency has not issued final guidance on key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability. “It is our understanding that FDA has forwarded the naming guidance to the Department of Health and Human Services (HHS), and this guidance is awaiting HHS’ clearance so it can be released for stakeholder comment,” wrote Senators Lamar Alexander (R-Tenn.) and Orrin Hatch (R-Utah). “In order to ensure the success of the biosimilar pathway, it is imperative that the scientific experts at FDA maintain the autonomy to implement the pathway as intended in a manner that puts the safety of patients first.”

The FDA’s slow pace in finalizing guidance on naming may have something to do with awaiting a World Health Organization (WHO) decision. The WHO issues its own guidance in an effort to standardize naming, although its guidance is voluntary—meaning the FDA could ignore it. But this summer, the WHO finally took a tentative stand on what constitutes an international nonproprietary name (INN).2 Brand-name companies want biosimilars to have some sort prefix or suffix added to the product’s brand name. Generic manufacturers oppose that, arguing it will encumber substitution. The WHO suggested that the current system for choosing INNs remain intact but that a four-letter code be attached to the end of every drug name that “uniquely identifies directly or indirectly the manufacturer and manufacturing site of the active substance in a biological product.”

The Biotechnology Industry Organization generally applauded the WHO draft decision. The Generic Pharmaceutical Association noted that the WHO move will be advisory and that the FDA, the European Medicines Agency, and other regulatory bodies will decide the best approach.

Some states are not waiting for the FDA to issue final guidance documents. In August, Raulo S. Frear, PharmD, of Boise, Idaho, President-Elect of the Academy of Managed Care Pharmacy (AMCP), testified before the Idaho State Board of Pharmacy on its proposed definitions of biosimilars and interchangeability. Interchangeability will dictate the success of biosimilars because a pharmacist can substitute an “interchangeable” biosimilar without getting a physician’s prior approval. The FDA will decide what constitutes interchangeability. The AMCP is concerned that Idaho will adopt a definition of “biosimilar” that varies from the one in the BPCIA. That would diminish interchangeability.

There is no argument that biosimilars will save U.S. consumers, and the federal government, billions of dollars a year once they penetrate here as they have in Europe and Asia. The FDA has either been overly cautious about approving biosimilars, or tangled in its own bureaucratic stasis. Neither explanation casts the agency in a positive light.


  1. U.S. Senate Committee on Health, Education, Labor, and Pensions. Alexander, Hatch call on Burwell to immediately release guidance on biosimilar drugs. [Press release] August 1, 2014. Available at: Accessed August 21, 2014
  2. World Health Organization. Biological qualifier: an INN proposal. July 2014;Available at: Accessed August 21, 2014