On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
12/9/2022
/ Biosimilars ,
Clinical Trials ,
Drug Pricing ,
EU ,
European Medicines Agency (EMA) ,
Expedited Approval Process ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
UK
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more