AbbVie, Pfizer reach licencing agreement for biosimilar Humira

AbbVie has granted a non-exclusive patent license allowing Pfizer to sell its Humira (adalimumab) biosimilar in many countries around the world, halting Pfizer’s patent dispute and allowing AbbVie to hold off another competitor for the next five years.

Under the licensing agreement, Pfizer may launch its copycat drug in Europe upon approval by the EMA and in the US from 20 November 2023. All litigation pending between the parties will now be withdrawn.

“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.

Pfizer’s biosimilar is currently in phase III development.

Humira is the world’s biggest-selling drug, generating over $18 billion last year – 65% of AbbVie’s total sales – and the emergence of copycats is expected to deal a heavy blow to the company’s profits, though it is investing in several therapy areas such as cancer and autoimmune diseases in the hopes of offsetting any losses.

AbbVie has reached similar agreements with seven other companies – Amgen, Samsung Bioepis/Merck, Mylan, Fresenius Kabi, Momenta and Novartis’ Sandoz division, all of whom have also agreed to launch their products in the US in 2023, though the exact timings differ.

Amgen, the first company to settle, has struck the earliest launch date of 31 January. Samsung Bioepsis will launch its product through its marketing partner Merck on 30 June.

Meanwhile, several biosimilars have already hit the market in Europe, and according to CEO Richard Gonzalez discounting has been at the high end of AbbVie’s estimates.

Boehringer Ingelheim, meanwhile, has opted against settling and will continue to fight AbbVie’s patent claims in court, in an attempt to get its biosimilar Cyltezo available in the US as soon as possible.

The financial details of all the agreements remain confidential.