🇺🇸 PYZCHIVA in United States

FDA authorised PYZCHIVA on 28 June 2024

Marketing authorisations

FDA — authorised 28 June 2024

Application: BLA761373
Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
Local brand name: PYZCHIVA
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved PYZCHIVA, manufactured by SAMSUNG BIOEPIS CO LTD, for manufacturing (CMC) on 20 December 2024. This approval was granted through a standard expedited pathway. The marketing authorisation holder is SAMSUNG BIOEPIS CO LTD, and the application number is BLA761373.

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FDA — authorised 28 June 2024

Application: BLA761425
Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
Local brand name: PYZCHIVA
Indication: INJECTABLE — SUBCUTANEOUS
Status: approved

The FDA granted marketing authorisation to PYZCHIVA, a product of SAMSUNG BIOEPIS CO LTD, on 13 March 2025. The marketing authorisation was granted under the standard expedited pathway. The approved indication for PYZCHIVA is listed in its labelling, but the specific indication is not specified in the available data.

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PYZCHIVA in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is PYZCHIVA approved in United States?

Yes. FDA authorised it on 28 June 2024; FDA authorised it on 28 June 2024.

Who is the marketing authorisation holder for PYZCHIVA in United States?

SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.