HealthLicensing and registrationsMedical researchDrug safety, medical device, and laboratory regulation
Why This Matters
This bill changes the approval process for biosimilar drugs by removing the requirement for certain clinical studies, making it easier for these drugs to reach the market.
If you use biosimilar medications, this bill could help bring more options to the market faster.
Who this affects
Patients using biosimilars · Pharmaceutical companies
What changes is this bill making?
1The bill allows biosimilar drugs to be approved without requiring studies on immunogenicity or comparative clinical efficacy.
2The Secretary of Health can still request studies on these factors but must provide a written justification.
