All Intellectual Property Matters for Pfizer’s Proposed Adalimumab Biosimilar Resolved
Pfizer may launch its adalimumab biosimilar upon approval by the European Medicines Agency in Europe. In the United States, the license period will begin on November 20, 2023.
“This settlement will facilitate patient access to Pfizer’s proposed adalimumab biosimilar which we expect to be an important addition to our broad portfolio of biosimilar medicines,” said Richard Blackburn, Global President, Inflammation and Immunology at Pfizer.
All litigation pending between the parties will be withdrawn. The financial details of the agreements are confidential.
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DISCLOSURE NOTICE: The information contained in this release is as of November 30, 2018. 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 Pfizer’s proposed adalimumab biosimilar, 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, the uncertainties inherent in research and development, including the ability to meet anticipated clinical 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; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for Pfizer’s proposed adalimumab biosimilar; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality the efficacy and safety information submitted, and, if approved, whether Pfizer’s proposed adalimumab biosimilar will be commercially successful; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Pfizer’s proposed adalimumab biosimilar; 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, 2017 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