Pfizer's Bevacizumab Biosimilar ZIRABEV Approved for Launch in Europe
Pfizer
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
PfizerOn February 19, the company announced that the European Commission (EC) had approved bevacizumab.BiosimilarsZIRABEV? (bevacizumab biosimilar) for the treatment of metastatic colorectal cancer, metastaticBreast Cancer, unresectable advanced metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell carcinoma, and persistent, recurrent, or metastatic cervical cancer.
This EC approval was based on a comprehensive data submission demonstrating the biosimilarity between ZIRABEV and the reference product. This included the Phase 3 comparative clinical study REFLECTIONS B739-03, which showed clinical equivalence and found no clinically meaningful differences between ZIRABEV and the reference product in the treatment of patients with advanced non-squamous NSCLC. This study served as the cornerstone of the entire REFLECTIONSClinical TrialAs part of the plan, approximately 400 subjects will be enrolled.
This approval follows the positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in December 2018. ZIRABEV has also been approved by the U.S. Food and Drug Administration (FDA) regulatory approval.
ZIRABEV is a biosimilar of Genentech’s blockbuster drug Avastin (bevacizumab), marketed by Roche. This monoclonal antibody (mAb) works by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein, thereby inhibiting the formation of new blood vessels (angiogenesis). ZIRABEV is the fifth biosimilar approved by Pfizer for use in Europe, demonstrating strong potential in mid-to-late stage development.BiosimilarsCandidate Product Portfolio.
“Pfizer is committed to expanding the availability of biosimilars for patients with serious diseases and helping to build a more sustainable healthcare system,” said Andreas Penk, President of International Development Markets at Pfizer Oncology. “We are proud that ZIRABEV has been approved as the company’s secondTumorBiosimilars. This milestone reflects Pfizer's commitment toBiosimilarsongoing commitment to continue bringing high-quality medicines to market and helping to reduce costs in cancer care.”(BioonBioon.com）