Amgen Settles Biosimilar Dispute With AbbVie; Enters Biosimilars Pact in China

In two separate moves, Amgen has resolved intellectual property-related litigation with AbbVie for its proposed biosimilar to AbbVie’s top-selling cancer drug, Humira (adalimumab), and has also formed a biosimilar agreement in China.

Under its agreement with AbbVie, AbbVie will grant to Amgen a non-exclusive license to AbbVie’s intellectual property relating to Humira beginning on certain dates in certain countries in which AbbVie has intellectual property. The license period will begin on January 31, 2023 in the US, on October 16, 2018 in most countries in the European Union, and on other dates in various countries in which AbbVie has intellectual property.  Amgen will pay royalties as specified under the agreements. The precise terms are confidential between the parties. All litigation pending between the parties will be dismissed, and Amgen has acknowledged the validity of AbbVie’s intellectual property related to Humira.

Humira is AbbVie’s top-selling drug with 2016 global sales of $16.0 billion. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the US Food and Drug Administration. This includes Amjevita (adalimumab-atto), a biosimilar to AbbVie’s Humira, which was approved by the FDA in September 2016 and in the European Union in March 2017. Its other biosimilar approved by the FDA is Mvasi (bevacizumab-awwb), a biosimilar to Roche’s cancer drug, Avastin (bevacizumab). Avastin had 2016 sales of CHF 6.78 billion ($6.76 billion).

In a separate move, Amgen has signed an agreement with Simcere Pharmaceutical Group, a Nanjing, China-headquartered pharmaceutical company, to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology.

Under the agreement, Amgen will be responsible for the co-development, marketing approval applications, and manufacturing of the biosimilars. Simcere will be responsible for distribution and commercialization in China while Amgen will have a limited right to co-promote the products. The biosimilars included in the agreement are a part of Amgen’s existing biosimilars portfolio.

Source: AbbVie, Amgen (AbbVie Settlement), and Amgen (China Agreement)


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