The proposed FDA guidelines, for example, allow for “indication extrapolation” for biosimilars, meaning they can be used across the same diseases as the original biologic, without additional, comprehensive testing in clinical trials.

“The FDA is not saying no clinical trials are needed,” Dr Charles said. “But we worry that if a biosimilar is tested only in rheumatoid arthritis, even with good results, can we assume that it will do the same for another disease state?”

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He further explained that in complex diseases, where some biologics carry a higher risk of immune system response, clinical trials remain vital for assessing whether to switch a patient from a brand-name drug to a biosimilar version. Not only should there be testing, where reasonable, for each indication, Dr Charles said, but results of these tests should also be separate from that of the reference innovator product on the label, so patients and their doctors can make better-informed decisions.

Two other unsettled issues still surround biosimilars: how best to name these products and how much actual savings consumers can expect.8

Dr Charles, who is also chief medical officer at the Vanderbilt Neuroscience Institute and director of telemedicine at the Vanderbilt University Medical Center in Nashville, TN, said his advocacy group supports labeling that clearly distinguishes biosimilars from biologics and not giving these drugs an identical name, which some generic companies initially supported.

For example, in these 2 FDA-approved indications, 1 biosimilar product carries a suffix that refers to the manufacturer (ie, filgrastim-sndz), while the other approved drug carries a randomly generated suffix (ie, infliximab-dyyb). Although no final decision has been made, Dr Charles said, the Alliance for Patient Access favors the label carrying the manufacturer’s identity to distinguish between them and also to aid in post-marketing surveillance.

As for cost savings from biosimilars, pharmaceutical manufacturers and individuals’ health insurers determine pricing, and the FDA has no authority over the decisions. However, the agency indicated that at least 19 biosimilars are in the pipeline awaiting marketing consideration, reflecting the growing interest in bringing biosimilars into competition with today’s blockbuster drugs.

Infliximab sales alone in 2015 illustrate the enormity of that market.9 According to Express Scripts, the nation’s largest manager of prescription drug benefits, sales of this 1 biologic drug totaled $4.5 billion last year.

“There’s obviously a huge market across biologics,” Dr McLeod said. “Some companies already have biosimilars in other countries, and they’re now trying to bring them into the United States. But whether there’s a huge cost savings [for patients] is still to be determined.”

Dr McLeod said it’s more likely the price change could be modest, as drug companies developing biosimilars hope to make their own profit. Pricing also depends on how much insurers are willing to pay and how much they pass on to patients as copays, he explained.

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Dr Charles, too, cited possible financial pressures, especially from the insurance industry. The scenario that concerns him most is the patient who is stabilized on a biologic and then urged to switch to a less-expensive biosimilar that lacks adequate testing for the patient’s disease.

“That’s when an insurer might suggest staying with the drug you want and paying a higher price,” he said, “or going on the biosimilar and paying much less.”


  1. FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: U.S. Food and Drug Administration; April 5, 2016. Accessed April 11, 2016.
  2. Tavernise, S, Pollack, Andrew. FDA approves Zarxio, its first biosimilar drug. The New York Times. March 6, 2015. Accessed April 11, 2016.
  3. Biosimilars overview. Patients for Biologics Safety and Access web site. Published April 13, 2016. Accessed April 13, 2016.
  4. Biologics: more treatment options are on the way.  U.S. Food and Drug Administration web site. Updated April 8, 2016. Accessed April 11, 2016.
  5. Hernandez, R. Biosimilars: the litigation and patent challenges to come. web site. May 4, 2015. Accessed April 12, 2016.
  6. Sandoz petitions the Supreme Court for review of biosimilar waiting period [news release]. Infocast Biosimilars Team; February 22, 2016.!Sandoz-Petitions-Supreme-Court-for-Review-of-Biosimilar-Waiting-Period/c7a5/56c666c60cf2c75daa859ef7. Accessed April 11, 2016.
  7. Conshafter A. FDA’s draft biosimilar labeling guidance falls short on patient safety measures. Institute for Patient Access web site. Published April 4, 2016. Accessed April 11, 2016.
  8. Conshafter, A. FDA’s second biosimilar approval hints at random naming system. Institute for Patient Access web site. Published April 6, 2016. Accessed April 11, 2016.
  9. 2016 drug pipeline full of blockbuster potential. Express Scripts web site. Published March 24, 2006. Accessed April 12, 2016.