EMA Validates Henlius’ Pertuzumab Biosimilar Application

The Milestone Adds Another Major Market To The Company’s Tally

The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.

man holding capsules in front of complete wavy national flag of Europe symbolizing health, medicine
(Shutterstock)

The European Medicines Agency has accepted for review Organon’s application for its Henlius-partnered Perjeta (pertuzumab) biosimilar, paving the way for approval in a major global market.

The Perjeta biosimilar was the subject of a $100m+ deal between Organon and the Chinese company Shanghai Henlius Biotech signed in June 2022. At the time, Organon agreed to pay...

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