Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.

ABSTRACT: The number of drugs developed by non-global companies, including biotech start-ups, has increased; however, their characteristics and impact on global regulatory approval are not well understood. Using a public database, we identified new molecular entities (NMEs) approved for hematologic malignancies in the US from January 2011 to December 2022. They were divided into those submitted by non-global companies (non-global group) and those by global companies (global group). We identified 48 NMEs, of which 19 (40%) were classified as non-global. Of these, 13 (68%) were from US-based companies. In the non-global group, 63% (12/19) of the NMEs had received accelerated approval in the US, of which only 50% (6/12) had a post-approval confirmatory trial by September 2023. Regarding the impact on t

SUBMITTER: Matsuda K 

PROVIDER: S-EPMC11652803 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature