As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...more
1/3/2023
/ America Invents Act ,
Biden Administration ,
Biosimilars ,
China ,
Drug Pricing ,
EU ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Governor Newsom ,
Interchangeability ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Purple Book ,
USPTO
On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a...more