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FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions

November 18, 2019

NEW YORK--(BUSINESS WIRE)--Nov 18, 2019--

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira ® (adalimumab), 1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. 2 For full details of indications please see the approved label.

“Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Richard Blackburn, Global President, Pfizer Inflammation and Immunology. “Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.”

The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of ABRILADA and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. 3

Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to drive cost savings for healthcare systems. With more than 10 years of global in-market experience and eight approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment.

Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. Our current plans are to launch in 2023. We will provide further updates as the date approaches.

About ABRILADA (adalimumab-afzb)

ABRILADA is a tumor necrosis factor (TNF) blocker and biosimilar to Humira. Adalimumab targets and blocks TNF, which is believed to help reduce inflammation. 4

IMPORTANT SAFETY INFORMATION for ABRILADA (adalimumab-afzb)

SERIOUS INFECTIONS

Patients treated with adalimumab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue ABRILADA if a patient develops a serious infection or sepsis.

Reported infections include:

Carefully consider the risks and benefits of treatment with ABRILADA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

HYPERSENSITIVITY

HEPATITIS B VIRUS REACTIVATION

NEUROLOGIC REACTIONS

HEMATOLOGIC REACTIONS

CONGESTIVE HEART FAILURE

AUTOIMMUNITY

IMMUNIZATIONS

ADVERSE REACTIONS

INDICATIONS

Please see full Prescribing Information for ABRILADA (adalimumab-afzb).

Pfizer Inc.: Breakthroughs that change patients’ lives

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, including innovative medicines and vaccines. 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 atwww.pfizer.com. In addition, to learn more, please visit us onwww.pfizer.comand follow us on Twitter at@Pfizerand@Pfizer_News,LinkedIn,YouTubeand like us on Facebook atFacebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of November 18, 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 ABRILADA (adalimumab-afzb) 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 ABRILADA 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 ABRILADA may be filed in any other jurisdictions; whether and when any such other applications for ABRILADA 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 ABRILADA 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 ABRILADA; 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 itssubsequent 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 Humira is a registered trademark of AbbVie.
2 ABRILADA™ (adalimumab-afzb) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12780. Accessed November 2019.
3 Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Available at https://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract. Accessed November 2019.
4 Zhao S, Chadwick L, Mysler E, Moots RJ. Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. Curr Rheumatol Rep. 2018;20(10):57. Published 2018 Aug 9. doi:10.1007/s11926-018-0769-6. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097048/. Accessed November 2019.

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CONTACT: Media Contact:

Steve Danehy

+1 (978) 273-3946

Steve.Danehy@pfizer.comInvestor Contact:

Ryan Crowe

+1 (212) 733-8160

Ryan.Crowe@pfizer.com

KEYWORD: NEW YORK UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH

SOURCE: Pfizer Inc.

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PUB: 11/18/2019 06:45 AM/DISC: 11/18/2019 06:45 AM

http://www.businesswire.com/news/home/20191118005208/en