Samsung Bioepis’ latest Biosimilar Market Report

South Korea’s Samsung Bioepis today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the USA, as well as the price and market share trends since each biosimilar’s launch.

“The first quarter of 2025 has witnessed substantial developments in market competition and regulatory paradigm. Among the most significant milestones was the launch of ustekinumab biosimilars following the loss of exclusivity for Stelara. This expansion has played a pivotal role in fostering market competition and encouraging more dynamic pricing strategies,” said Thomas Newcomer, vice president, head of US commercial operations at Samsung Bioepis.

“In addition, the FDA and EMA have intensified their efforts to streamline biosimilar development. Notably, the agencies are considering waiving Comparative Clinical Efficacy Studies (CES) and interchangeability switching studies in case of FDA, and these streamlined efforts can significantly reduce both time-to-market and development costs. The agencies’ evolving approach is poised to accelerate biosimilar adoption, creating new opportunities for manufacturers while intensifying competition across the sector,” he added.