NORTH CHICAGO, Ill., July 17, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today patent license agreements with Mylan over its proposed biosimilar adalimumab product. Under the terms of the agreements, AbbVie will grant Mylan a non-exclusive license on specified dates to AbbVie's intellectual property relating to HUMIRA in the United States and in various other countries around the world in which AbbVie has intellectual property, excluding Europe.
Mylan's U.S. license will begin on July 31, 2023, and will not be accelerated by Amgen's or Samsung Bioepis' entry. Mylan will pay royalties to AbbVie for licensing its HUMIRA patents once its biosimilar product is launched. Mylan acknowledges the validity of the licensed patents. AbbVie will make no payments to Mylan.
"AbbVie's HUMIRA patents reflect the groundbreaking work of AbbVie scientists in the field of fully-human biologics and our investment in patient-focused innovation," said Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary, AbbVie. "We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its HUMIRA biosimilar maintains that balance."
On September 28, 2017, AbbVie announced a global resolution with Amgen to enter the U.S. on January 31, 2023, and on April 5, 2018, AbbVie announced a similar resolution with Samsung Bioepis to enter the U.S. on June 30, 2023.
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2017 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.