Biosimilar uptake still limited in the U.S.
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The European Medicines Agency approved the first biosimilar in Europe in 2006. It was almost 10 years before the United States followed. Despite potential savings for payers and patients, biosimilar uptake in the U.S. remains limited.
In a virtual presentation for the Interdisciplinary Autoimmune Summit, Jonathan Kay, MD, from UMass Memorial Medical Center, said the potential risk of an individual switching to a lower-cost biosimilar should be outweighed by the potential benefit of expanded access.
“The availability of biosimilars should decrease the cost of treating patients,” he said. “Lower price biosimilars introduce market competition and provoke discounts and rebates for bio originators.”
Although 26 biosimilars have obtained approval in the U.S., only 15 are commercially marketed, including only three of the four approved Remicade (infliximab, Janssen) biosimilars and none of the five approved Humira (adalimumab, AbbVie) biosimilars.
In Europe, Kay said the availability of multiple biosimilars of the same reference drug has helped reduced prices.
In Norway, there is a bidding process for hospital medications in which drug manufacturers submit a lowest-possible price to the government for the next year. In the 2014 Norwegian national hospital tender for biologicals, this bidding process resulted in a 39% discount for the infliximab biosimilar Remsima (Celltrion) compared with the reference drug. In 2015, that discount increased to 69%.
“As a result of this price reduction, as of March 2015, the use of biosimilar infliximab exceeded that of reference infliximab,” Kay said. “Subsequent use of reference infliximab continued to decrease, while use of biosimilar infliximab continued to increase.”
Kay said that the price of biosimilar adalimumab was less than $3,000 a year in the United Kingdom compared with between $38,000 and $50,000 per year for Humira in the United States.
“One hundred patients can be treated with biosimilar adalimumab in the United Kingdom for the cost of treating six to eight patients with Humira in the United States,” he said. “This vast disparity in terms of access based upon cost illustrates the advantage of having a biosimilar available on the market.”
Competition from biosimilars has also driven down costs for bio-originators. When the Europe Product Forecast for Amjevita estimated that there was going to be 140 million euros of sales by 2022, AbbVie reduced the price of reference adalimumab by 80% in the Swedish National Tender and became the exclusive supplier of the drug in 2019, Kay said. While a licensing period for adalimumab began in October 2018 in Europe, AbbVie reached agreements with multiple developers in the U.S. that will delay the marketing of biosimlar adalimumab until Jan. 31, 2023.
Kay said slow regulatory processes, patent litigation and other factors have all contributed to the limited uptake of biosimilars in the U.S.
“There has been no systematic effort to educated physicians and patients who are concerned about biosimilar safety and efficacy,” he said. “And there is no economic incentive to health care providers in the United States to prescribe a lower-cost biosimilar.”
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Kay J. Biosimilars for IMIDs: Availability, Affordability, and Interchangeability. Presented at: Interdisciplinary Autoimmune Summit; July 10-12, 2020 (virtual meeting).
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