As part of Pfizer's commitment to expanding its oncology biosimilars pipeline, the company is progressing its biosimilar trastuzumab marketing applications, which have been accepted for review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).About PF-05280014 PF-05280014 is a monoclonal antibody (mAb) that is in development as a potential biosimilar for all currently approved indications of Herceptin (trastuzumab). Herceptin is currently approved in the U.S., EU and other markets for HER2-positive breast cancer and gastric cancer. PF-05280014 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed. About Pfizer: 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 September 10, 2017. 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 PF-05280014 and Pfizer's proposed biosimilars pipeline, including their 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, the uncertainties inherent in research and development, including the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when any applications for PF-05280014 or any other biosimilars in development may be filed with regulatory authorities in any jurisdictions other than the U.S. and the EU; whether and when the FDA, the EMA and regulatory authorities in any such other jurisdictions may approve any such applications for PF-05280014 or any other biosimilars in development, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; intellectual property and/or litigation implications; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of PF-05280014 or any other biosimilars in development; 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, 2016, 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 10-Q and 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 Herceptin ® is a registered trademark of Genentech, Inc. 2 United States Food and Drug Administration. Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/ucm071590.pdf. Accessed October 27, 2016.