US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).
Zirabev (bevacizumab-bvzr) is a proposed biosimilar to Roche’s Avastin (bevacizumab), which had worldwide sales of CHF 6.8 billion (Euros 5.95 billion) in 2016, before the advent of biosimilars . The patents on Avastin expires in the US in July 2019 and will expire in Europe in January 2022 .
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
Zirabev has been approved for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
Zirabev has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.
FDA’s approval of Zirabev was based on a comprehensive submission package demonstrating biosimilarity of Zirabev and the originator product, Roche’s Avastin (bevacizumab). This included results from the phase III REFLECTIONS B739 03 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and Avastin in patients with advanced non-small-cell lung carcinoma (NSCLC) .
The approval of Zirabev marks the sixth biosimilar from Pfizer (and its subsidiary Hospira) to be approved by FDA. Inflectra (infliximab-dyyb) was approved in April 2016, Ixifi (infliximab-qbtx) in December 2017, Retacrit (epoetin alfa-epbx) in May 2018, Nivestym (filgrastim-aafi) in July 2018 and Trazimera (trastuzumab-qyyp) in March 2019 .
Zirabev is the second bevacizumab biosimilar to be approved by FDA. Amgen/Allergan’s Mvasi (bevacizumab-awwb) was approved in September 2017 .
Zirabev was also approved in Europe in February 2019 . However, in the UK Pfizer is experiencing problems bringing its bevacizumab biosimilar to the market. The company has been unable to get a UK Arrow declaration clearing it of infringement of pending bevacizumab patent applications through the biosimilar it plans to import from Belgium because Roche has already de-designated the UK parts of the applications.
Biosimilars of bevacizumab
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