By Fineline Cube 
Guangzhou-based biotech Bio-Thera Solutions (SHA: 688177) announced the termination of a multi-center, randomized, double-blinded Phase I/III study evaluating BAT3306 combined with chemotherapy versus Keytruda combined with chemotherapy in patients with stage IV non-small cell lung cancer (NSCLC). This decision follows recent updates from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding biosimilar product approvals.
Regulatory Policy Shifts
Recent communications from the FDA and the EMA’s April 2025 reflection paper indicate that efficacy comparison studies are no longer essential for most biosimilar product approvals in the U.S. and EU. This shift has prompted companies to reassess their clinical trial strategies for biosimilar products.
Industry Response
Globally, two companies developing pembrolizumab biosimilars have already halted their Phase III efficacy comparison trials. Formycon AG removed the Phase III trial results from its market filing, relying instead on Phase I and analytical data. Sandoz AG announced plans to streamline its Phase III trial for a pembrolizumab biosimilar in untreated metastatic non-squamous NSCLC patients.
Bio-Thera’s Decision
After careful consideration, Bio-Thera concluded that the BAT3306-002 study is no longer necessary for BAT3306’s regulatory review in the U.S. and EU. The company will continue to engage closely with regulatory authorities and will prudently assess the latest biosimilar evaluation policies to determine the future path for the BAT3306 project.-Fineline Info & Tech