Samsung Bioepis releases Q3 2024 U.S. biosimilar market report
Samsung Bioepis has released its Third 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 latest report is the sixth-edition of the Samsung Bioepis’ Quarterly Biosimilar Market Report including updates of biosimilar approval statuses, the definition of interchangeability in biosimilars and its exclusivity as well as a successful case of adalimumab biosimilar adoption through an interview with a pharmacy benefit manager at Scripius.
“The U.S. biosimilar market is continually evolving and the need to monitor change on a routine basis has become critical to stakeholder evaluations. Our report investigates the market share and price trends for each molecule, allowing readers to access and compare current market dynamics on a timely basis,” said Thomas Newcomer, vice president, head of market access, U.S., at Samsung Bioepis. “The biosimilar market is no longer simple. However, as always, we strive to deliver quick and organized information to the U.S. healthcare market.”
[Read more: AAM report: Generic, biosimilar drugs generate $408B in savings]
A new chapter has been added in the latest report titled ‘Biosimilar Deep Dive’, which encompasses two topics:
- Frequently Asked Questions: Interchangeable Biosimilars and Exclusivity
- Payer Interview with Scripius on Adalimumab Biosimilar Adoption.
The FAQ defines the term ‘interchangeable biosimilars’ and its exclusivity which is frequently asked in the market. It includes the Food and Drug Administration noticeable shift and stance towards interchangeable biosimilars.
Among the key findings:
- As of Jun 2024, the Food and Drug Administration has approved a total of 57 biosimilars across 17 unique biological molecules. Of the 57 approvals, 39 biosimilars have launched in the U.S. market.
- In the last quarter, eight new biosimilars were approved in the U.S.:
• Selarsdi and Pyzchiva for Stelara (ustekinumab) biosimilar
• Hercessi for Herceptin (trastuzumab) biosimilar
• Opuviz, Yesafili, and Ahzantive for Eylea (aflibercept) biosimilar
• Bkemv for Soliris (eculizumab) biosimilar • Nypozi for Neupogen (filgrastim) biosimilar
[Read more: Samsung Bioepis releases Q2 2024 U.S. biosimilar market report]
- On average, biosimilars have gained 53% market share within three years (12 quarters) post initial launch. Each molecule has demonstrated unique biosimilar uptake and can be categorized into fast or slow uptake speed markets. 1) Fast Uptake Speed: Oncology , ophthalmology and pegfilgrastim biosimilars.
- Three years post launch, average biosimilar market share reached 75%.) Slow Uptake Speed: Immunology, filgrastim, epoetin alfa and insulin glargine biosimilars. On average, only 23% biosimilar market share was achieved by Year 3.
- Biosimilar launches have led to significant price decreases over time. On average, ASP declined by 56% five years (20 quarters) post first biosimilar launch with more mature markets demonstrating increasing price concessions. Recent observed increases in ASP for some markets (e.g. trastuzumab, bevacizumab, pegfilgrastim and filgrastim) may be due to: 1) artifacts of newly-launched, low market share biosimilars with ASPs that reflect WAC pricing and 2) intentional ASP repositioning of some biosimilars.
Samsung Bioepis 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.
Read the report here.