Jonathan Kay, MD


December 07, 2016

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Hello. I am Jonathan Kay, the Timothy S. and Elaine L. Peterson Chair in Rheumatology and professor of medicine at the University of Massachusetts Medical School in Worcester, Massachusetts. Welcome to my Medscape blog. I would like to update the discussion of biosimilars in the United States, as we recently had two additional biosimilars approved for the treatment of inflammatory diseases. In late August 2016, the etanercept biosimilar Erelzi™, manufactured by Sandoz, was approved by the US Food and Drug Administration (FDA) from the reference product Enbrel®.[1] In September 2016, adalimumab biosimilar Amjevita™, manufactured by Amgen, was also approved by the FDA from the reference product Humira®.[2]

This now brings to three the number of biosimilars for inflammatory diseases that are approved. Pfizer has announced that starting in November 2016 its infliximab biosimilar, Inflectra®, will be available in the US market, from the reference product Remicade®.[3] This drug is already available in 75 countries around the world, and there are a number of publications that are documenting adequate safety and efficacy of the biosimilar infliximab.

In the United States, this is an at-risk launch because the patent litigation with Janssen continues and has not yet been settled. If this litigation fails to be adjudicated in favor of Pfizer, then Pfizer will have to withdraw Inflectra from the market and pay penalties to Janssen. However, if Pfizer ends up winning the patent litigation, Inflectra will continue in the marketplace.

In the Wall Street Journal in early October, Pfizer announced that it was going to market Inflectra at a 15% discount compared with the average wholesale price of Remicade, the infliximab reference product marketed by Janssen.[4] This is perhaps not an adequate reduction in price, especially compared with the 69% price reduction available in Norway. Additionally, third-party payers get discounts and rebates from the manufacturer, so that the cost to the insurance company providing infliximab to patients may be lower for the reference product than for the biosimilar.

This poses a very interesting problem because if the insurance company goes for the lower-cost medication, which in this case might be the originator or the reference product, then the biosimilar company will not generate sales. If this happens consistently, biosimilars may not remain on the market. If that were to happen, the competition would be removed and the price of the reference product might go back up. Biosimilars have a very important role in the medical economy because they introduce price competition into the marketplace and reduce the cost of expensive biopharmaceuticals, so that more biopharmaceuticals are available to patients to effectively treat their diseases.

This is but one hurdle to the uptake of biosimilars. Another hurdle is education gaps, whereby physicians, other providers, and patients do not truly understand the nature of biosimilars—that these are replicas of the reference product which are equivalent in efficacy, comparable in safety, have the same amino acid structure, and display no clinically meaningful differences from the reference product. These medications differ from the reference product perhaps as much as one lot of the reference now might differ from the original lot.

Understanding that these are safe and effective medications manufactured by companies with tremendous experience in the manufacture of biopharmaceuticals should increase some comfort level to patients and physicians in prescribing biosimilars. We now have four biosimilars approved in the United States, only one of which is available: Zarxio®, the filgrastim biosimilar that was marketed by Sandoz in September 2015 as a biosimilar of Neupogen®, Amgen's originator product.[5] We will shortly have an infliximab biosimilar to treat inflammatory diseases.

There are over 50 biosimilars in development for treatment of many different diseases, including oncologic indications and inflammatory diseases. Certainly this area continues to grow at an exponential pace. I will keep you updated in my blog on Medscape. I look forward to seeing you again on Medscape. I am Dr Jonathan Kay.


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