Biosimilars in the U.S.: More Approvals But Not More Access

Biosimilars have the potential to significantly reduce treatment costs. We take a look at the growing biosimilar pathway.
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U.S. Biosimilar Market

Since the first U.S. biosimilar was approved in 2015, the number of approved biosimilars has increased steadily year-over-year. In fact, in 2018, the U.S. Food and Drug Administration (FDA) approved seven biosimilars medications, compared to five the year before. Approved biosimilars are not interchangeable with the innovator product or with each other. However, they do not have clinically meaningful distinctions in safety, purity and potency from the original biologics. Eventually, the increased competition they will bring will result in cost savings for patients and payers.

Although 16 biosimilars have received FDA approval, only six presently are available on the U.S. prescription market. First-time biosimilars launched in 2018 were Retacrit and Fulphila, which are, respectively, competitors to Epogen/Procrit and Neulasta, products that recorded combined U.S. sales of nearly $5.9 billion in 2017. Other biosimilars available in the U.S. are for Remicade (Zarxio and Renflexis) and Neupogen (Zarxio and Nivestym). According to IQVIA, 2017 U.S. sales for the four branded products totaled $11.8 billion. The launches of approved biosimilars to other products either are tied up in patent litigation or the companies involved have reached settlement agreements ultimately delaying a launch.

What’s Expected for 2019

At least 10 biosimilar medications currently are under FDA review, any or all of which could be approved before the end of 2019. None of them is a “first-time” biosimilar, but if launched, they will increase competition with their corresponding branded products. We do, however, anticipate the launches of Ogivri and Truxima, the first biosimilars for Herceptin and Rituxan, which consistently rank in the top 10 drugs by spend. A third product, a biosimilar to Enbrel, could also launch. In addition, we could see more biosimilar competitors to Neupogen, Neulasta and Remicade. Although biosimilars to Avastin and Humira have been approved by the FDA, their launches likely will be delayed until 2020 and 2023, respectively, due to ongoing litigation and/or settlement agreements.


The first biosimilar to Herceptin (Genentech), Ogivri was FDA approved in December 2017 to treat certain breast cancers. Recently, Herzuma also received approval in the U.S. However, due to active patents and settlement agreements between manufacturers, launch of a biosimilar has been delayed. One of the key patents expires in June 2019, however; and a recent earnings call from Genentech, the brand manufacturer, indicated they are expecting the first Herceptin biosimilar to reach the U.S. market during the second half of 2019. Other companies, including Pfizer, Merck/Samsung Bioepis and Amgen/Allergan,  also are developing Herceptin biosimilars. At least one has an FDA action date in 2019, so the market could be competitive by the end of the year. In 2017, Herceptin had annual U.S. sales of approximately $2.8 billion according to IQVIA.


On Nov. 28, 2018, the FDA approved Truxima, the first U.S. biosimilar to Genentech’s Rituxan. Truxima is indicated for use alone or in combination with chemotherapy to treat adult patients with certain types of non-Hodgkin’s lymphoma (NHL). Due to patent protection, Truxima was only approved for the three NHL indications. Rituxan also is approved to treat chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosis, microscopic polyangiitis and pemphigus vulgaris. Pfizer has developed another biosimilar to Rituxan which could be approved in July 2019. Once again, though, timing for the biosimilars’ availability is unknown, as the terms of  settlement agreements between the manufacturers have not been made public. U.S. annual sales for Rituxan were approximately $4 billion in 2017.


Erlezi, a biosimilar to Enbrel (Amgen), also could launch if litigation continues to progress and a ruling comes back in favor of the biosimilar. However, if the Enbrel patents are ruled valid, its first biosimilar could be delayed until at least 2028. As estimated by IQVIA, Enbrel was the #5 top-selling drug in the U.S for 2017 with $5.2 billion.

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