Ha Kung Wong

Ha Kung Wong

Venable LLP

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Biosimilars Approved in the EU are Considered Interchangeable

​​​​​​​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

10/3/2022  /  Biosimilars , EU , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Interchangeability , Marketing Authorization Application , Pharmaceutical Industry , Prescription Drugs

First Interchangeable FDA Approval without a Switching Study

Cimerli™ (ranibizumab-eqrn) was FDA approved on August 2, 2022 as interchangeable with Lucentis® (ranibizumab). Cimerli is the third interchangeable biosimilar approved in the US, following Semglee® (insulin glargine-yfgn),...more

9/9/2022  /  Biosimilars , Coherus , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs
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