FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin

By | July 3, 2019

FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin

Friday, June 28, 2019 – Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 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.2

“Biosimilars like Zirabev can help increase access to impactful therapies, driving market competition that may ultimately lower costs and help address the diverse needs of patients living with cancer,” said Andy Schmeltz, Global President, Pfizer Oncology. “We are proud to add Zirabev to our growing oncology portfolio for U.S. patients living with a wide variety of tumor types.”

The FDA approval was based on review of a comprehensive data package which demonstrated biosimilarity of Zirabev to the reference product. This includes results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between Zirabev and the reference product in patients with advanced non-squamous NSCLC.3

“Zirabev represents a welcome addition to the treatment armamentarium in its approved indications, potentially providing physicians with a medicine that has a similar safety profile and efficacy as the reference product,” said Dr. Niels Reinmuth, Department of Thoracic Oncology, Asklepios Lung Clinic, Munich-Gauting, Germany and lead author of the REFLECTIONS B7391003 study.4 “The FDA’s approval of Zirabev may provide an important new option for the treatment of multiple forms of cancer.”

Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to create a more sustainable healthcare system. With more than 10 years of global in-market experience and six approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. Zirabev is Pfizer’s second oncology monoclonal antibody (mAb) biosimilar to be approved by the FDA, following the FDA approval of TRAZIMERA™ (trastuzumab-qyyp) in March 2019.5 Zirabev was also approved for use in the European Union (EU) in February 2019 for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent NSCLC, advanced and/or metastatic RCC and persistent, recurrent or metastatic carcinoma of the cervix.6

About Zirabev (bevacizumab-bvzr)

Zirabev is a mAb biosimilar of the reference product, Avastin, which works by inhibiting the formation of new blood cells (angiogenesis) by specifically recognizing and binding to vascular endothelial growth factor (VEGF) protein. As part of the REFLECTIONS clinical trial program, Zirabev has been studied in nearly 400 patients to date.3,7,8,9

INDICATIONS

Metastatic Colorectal Cancer

Zirabev, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).

Zirabev, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.

Limitation of Use: Zirabev is not indicated for adjuvant treatment of colon cancer.

First-Line Non-Squamous Non-Small Cell Lung Cancer

Zirabev, in combination with carboplatin and paclitaxel, is indicated for the first line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).

Recurrent Glioblastoma

Zirabev is indicated for the treatment of recurrent glioblastoma (GBM) in adults.

Metastatic Renal Cell Carcinoma

Zirabev, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC).

Persistent, Recurrent, or Metastatic Cervical Cancer

Zirabev, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

Please see full Prescribing Information for Zirabev (bevacizumab-bvzr).

About Pfizer Oncology

At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 18 approved innovative cancer medicines and biosimilars across more than 20 indications, including breast, prostate, kidney, lung and hematology. Pfizer Oncology is striving to change the trajectory of cancer.

Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of June 28, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Zirabev (bevacizumab-bvzr), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the launch timing and commercial success of Zirabev in the United States; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for Zirabev may be filed in any other jurisdictions; whether and when any such other applications for Zirabev that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether Zirabev will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Zirabev; uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to the innovator product; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

  1. 1 Avastin is a registered trademark of Genentech Inc.
    2 Zirabev™ (bevacizumab-bvzr) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=11860.
    3 Socinski MA, Von Pawel J, Kasahara K, et al. A comparative clinical study of PF-06439535, a candidate bevacizumab biosimilar, and reference bevacizumab, in patients with advanced nonsquamous non-small cell lung cancer. Abstract 109. Presented at ASCO 2018.
    4 American Cancer Society. Cancer Facts & Figures 2019. Available at https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf. Accessed June 2019.
    5 TRAZIMERA™ (trastuzumab-qyyp) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761081s000lbl.pdf. Accessed June 2019.
    6 European Medicines Agency. Zirabev Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/zirabev-epar-product-information_en.pdf. Accessed June 2019.
    7 Knight B, Rassam D, Liao S, et al. A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers. Cancer Chemother Pharmacol. 2016. 77:839-846.
    8 Clinicaltrials.gov. NCT02031991. A pharmacokinetic study comparing PF-06439535 and bevacizumab in healthy male volunteers (REFLECTIONS B739-01). Available at https://clinicaltrials.gov/ct2/show/NCT02031991?term=reflections+bevacizumab&rank=1. Accessed June 2019.
    9 Pfizer. Pfizer announces positive top-line results from the comparative REFLECTIONS B7391003 study for PF-06439535, a potential biosimilar to Avastin (bevacizumab). Available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_the_comparative_reflections_b7391003_study_for_pf_06439535_a_potential_biosimilar_to_avastin_1_bevacizumab. Accessed June 2019.

Source: Pfizer Inc.

Posted: June 2019

Zirabev (bevacizumab-bvzr) FDA Approval History

Drugs.com – New Drug Approvals