Humira (adalimumab) is a treatment for rheumatoid arthritis and Crohn’s disease, which managed to bring in $18.43bn (€15.76bn) in sales last year. As a result of these sales, it has been a primary target for a number of biosimilar developers.
Two companies had previously developed biosimilars to rival Humira but then subsequently agreed licensing deals with AbbVie, first with Amgen and then with Samsung Bioepis.
In these cases, the companies agreed to delay the launch of their products until 2023 in the US and now Mylan has followed suit. The news is a victory for AbbVie, given how central the earnings of the product are to the company’s revenue.
Laura Schumacher, executive vice president, external affairs, general counsel and corporate secretary at AbbVie, said in a statement, “We understand the importance of balancing innovation and accessibility, and our agreement with Mylan for its Humira biosimilar maintains that balance.”
The agreement with Mylan sees AbbVie receive royalties on the patents once the product enters the market; such a deal was also reached with Amgen and Samsung Bioepis, meaning that AbbVie will still be able to earn something from the biosimilar erosion of Humira’s earnings in 2023.
There is one company that has not yet agreed a deal with AbbVie, despite having FDA and EU approvals for its Humira biosimilar, in Boehringer Ingelheim. It received approval last year in the US but has not attempted to enter the US market yet; given the other companies’ inclination to accept licensing agreements, Boehringer appears to be considering its options in the face of AbbVie’s patent protection of Humira.
In certain countries in Europe, AbbVie’s patent protection will no longer apply from October 16, 2018, when both AbbVie’s and Samsung Bioepis will be free to begin marketing their biosimilars. Mylan’s licensing deal with AbbVie did not include any provisions regarding European launch of its biosimilar.