Pfizer, AbbVie settle global IP for Humira biosimilar, paving way for European launch

In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes concerning Pfizer’s proposed biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug, Humira (adalimumab). This agreement marks a major milestone in Pfizer’s mission to broaden its portfolio of biosimilar medications, as it acquires a non-exclusive patent license to market the biosimilar across several countries.

Under the agreement, Pfizer will pay royalties to AbbVie for the licensed patents associated with Humira, a drug known for its extensive indications across autoimmune conditions like rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis, and ulcerative colitis. However, AbbVie has agreed not to impose any financial obligations on Pfizer, and both parties have kept specific terms of the licensing agreement confidential.

The license arrangement allows Pfizer to debut its Humira biosimilar in the European Union following approval from the European Medicines Agency (EMA). In the United States, Pfizer’s entry into the market will commence on November 20, 2023. The deal effectively concludes ongoing litigation between the two pharmaceutical giants, offering a clear path forward for Pfizer’s adalimumab biosimilar in some of the world’s largest drug markets.

Pfizer’s Global President of Inflammation and Immunology, Richard Blackburn, commented that this settlement enhances patient access to Pfizer’s biosimilar lineup, positioning the adalimumab biosimilar as a pivotal addition to its extensive biosimilar medicine offerings. This move aligns with Pfizer’s strategic vision to bolster its biosimilar segment, providing more cost-effective treatments for conditions typically addressed by expensive biologics like Humira.

Competition in Biosimilar Market Intensifies

Pfizer’s entry is not without competition. Earlier, Mylan, in collaboration with Fujifilm Kyowa Kirin Biologics, launched Hulio—a biosimilar version of Humira—across major European markets following the European Commission’s approval for indications similar to those of the reference drug. Furthermore, Sandoz, a Novartis subsidiary, received EMA approval in July 2018 for Hyrimoz, another Humira biosimilar, for multiple indications, further establishing the competition in the biosimilar market.

As the biosimilar landscape grows more crowded, patients are set to benefit from increased treatment options and potentially lower drug prices. Pfizer’s latest settlement with AbbVie reflects the pharmaceutical industry’s broader trend toward resolving IP hurdles, fostering competition, and driving down costs for high-impact biologic drugs.

Industry Insight: Increasing Biosimilar Access

Industry experts suggest that the ongoing entry of Humira biosimilars in major markets could significantly impact the pricing and accessibility of rheumatoid arthritis treatments. Humira has historically been one of the highest-grossing drugs globally, often linked with substantial healthcare costs. Biosimilars offer a route to reduce these expenses, providing more affordable options for patients without compromising therapeutic efficacy. Pfizer’s deal with AbbVie may serve as a strategic precedent, as more pharmaceutical companies explore biosimilar development to meet market demand.