Pfizer Signs Licensing Deal With Abbvie on Adalimumab Biosimilar Candidate

Pfizer announced on November 30 that it had indeed joined the several biosimilar adalimumab makers who have signed agreements with Abbvie. According to the announcement, Pfizer will market this agent (PF-06410293), if approved by the Food and Drug Administration, in November 2023. This would make it the sixth adalimumab biosimilar to launch, just before Momenta’s M923 agent and just after Sandoz’s biosimilar Hyrimoz.

Similar to the Pfizer's Biosimilar Adalimumabother signed agreements, Abbvie will receive a licensing fee from Pfizer and will waive any patent litigation involving Pfizer’s agent.

Although Pfizer’s PF-06410293 successfully completed a phase 3 study in 597 patients with rheumatoid arthritis, it has not yet announced an FDA 351(k) filing for approval. The trial demonstrated this biosimilar to result in equivalent outcomes compared with the originator agent Humira®.

This agent has not been approved for use in the EU, either. In other words, it will be at the back of the pack of adalimumab competition in the EU and the US, if it is ultimately approved. Although Pfizer is moving towards a potential portfolio of automimmune products and could gain some leverage in this manner, they will face poor timing and heavy launch competition for adalimumab in both major economic markets. Therefore, it would not be surprising if Pfizer seeks a partner to market it or another company to purchase it somewhere along the line.

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