Celltrion to accelerate biosimilar pipeline on eased US regulations

Celltrion said Friday it will immediately apply newly eased US biosimilar development rules to its pipeline, a move expected to cut development costs and shorten timelines. The decision follows the recent release of the fourth revision of the biosimilar development Q&A guidelines by the US Food and Drug Administration, which simplifies pharmacokinetic testing requirements for biosimilars. A key change in the revision relaxes the criteria for reference drugs used in clinical comparisons. Previous

By The Korea Herald