Novartis' Sandoz unit on Thursday announced a global resolution of all intellectual property-related litigation with AbbVie concerning the former's proposed biosimilar Hyrimoz for the reference drug Humira (adalimumab). The resolution paves the way for a 2018 launch in key European markets and also secures US market entry planned for 2023, Novartis said.
Stefan Hendriks, global head of biopharmaceuticals at Sandoz, commented "this settlement helps remove uncertainty regarding when our biosimilar [Hyrimoz] will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease."
Under the terms of the settlement, AbbVie has awarded Sandoz a non-exclusive licence to its intellectual property related to Humira beginning on October 16 in most EU countries and as of September 30, 2023, in the US. Meanwhile, AbbVie will receive royalties from Sandoz in exchange for licensing the patents. The exact terms of the payments were not disclosed.
AbbVie general counsel Laura Schumacher said "we continue to believe biosimilars will play an important role in our healthcare system, but we also believe it is important to protect our investment in innovation. This agreement accomplishes both objectives."
Novartis received European approval for Hyrimoz in July, while its US filing for the biosimilar remains under review by the FDA. The drugmaker had previously identified Hyrimoz as one of as many as five biosimilars that it could launch by 2020.
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