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Samsung Bioepis releases Q2 2024 U.S. biosimilar market report

As of April 2024, the FDA has approved a total of 48 biosimilars across 15 unique biological molecules, and of the 48 approvals, 38 biosimilars have launched in the U.S. market, per the report.
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Samsung Bioepis has released its Second Quarter 2024 Biosimilar Market Report, which includes the latest Average Sales Price information of all biosimilars and reference products available in the U.S. market. 

The company has been publishing the report every quarter since April 2023 to provide the latest market share and price trends of all biosimilars available in the United States, after the Centers for Medicare & Medicaid Services publishes updated quarterly ASP values for each product. This fifth-edition of the Samsung Bioepis Quarterly Biosimilar Market Report delves into some implications of the Inflation Reduction Act with respect to biosimilars, as well as the biosimilars market share and price trends. 

“Over the past year, we have strived to provide the U.S. market with the latest biosimilar insights through our report, and we are grateful for the positive reception from our readers,” said Thomas Newcomer, vice president, head of market access, U.S., at Samsung Bioepis. “As we move forward, Samsung Bioepis remains committed to delivering high-quality, safe, and effective biosimilars. Our goal is to be part of the solution in reducing patients' out-of-pocket expenses, while offering savings to the U.S. healthcare system as a whole.”

[Read more: AAM report: Generic, biosimilar drugs generate $408B in savings]

Some of the key insights from the report include:

  • As of April 2024, the  Food and Drug Administration has approved a total of 48 biosimilars across 15 unique biological molecules. Of the 48 approvals, 38 biosimilars have launched in the U.S. market. 
     
  • In the last quarter, three new biosimilars were approved in the U.S.: Simlandi for Humira (adalimumab) biosimilar; Jubbonti/Wyost for Prolia/Xgeva (denosumab) biosimilar; and Tyenne for Actemra (tocilizumab) biosimilar.
     
  • As of February 2024, adalimumab biosimilar market share has reached 4%, increasing 2% compared to the previous quarter. Nine biosimilars are available at different pricing options: low WAC (85-86% less than Humira), high WAC (5% below Humira) and dual/multiple pricing options covering both high and low WAC. 
     
  • Originators are taking various strategies to compete with biosimilars, e.g. launching unbranded versions of originator products or by lowering or matching the ASPs of originator products to compete with biosimilars. In markets where originators have competitive pricing or unbranded products, originators have maintained a steady market share or dominant market position.

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

  • In some markets where the ASPs have fallen dramatically, e.g. trastuzumab, filgrastim, pegfilgrastim, some brands have shown price corrections.
     
  • In an effort to lower prescription drug costs, the Inflation Reduction Act will have a dramatic impact on manufacturer and plan sponsor economics. These changes result in opposing forces on the future growth, adoption and incentivization of biosimilars. 

To access the full report, please visit here.

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