Pfizer drug launch delayed to November 2023 after deal with AbbVie

AbbVie has granted Pfizer a non-exclusive license to market its Humira (adalimumab) biosimilar in the U.S., which will see Pfizer delay the launch of a copycat product to November 2023.

The deal is set to end an intellectual rights dispute between the two companies, over a proposed Pfizer biosimilar adalimumab referring to Humira. All litigation over the Pfizer’s proposed product will also be dropped.

Under the terms of the deal, AbbVie said Pfizer’s U.S. license, which begins on November 20, 2023, will not be accelerated by the entry of companies that already have licenses.

AbbVie declined to reveal the details of the deal, saying these were confidential. The company only said “Pfizer will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity of the licensed patents. AbbVie will make no payments to Pfizer.”

Pfizer’s surprisingly withdraws European licensing application

According to the agreement, Pfizer can launch its product in Europe after approval from the European Medicines Agency (EMA). However, shortly after the deal with AbbVie was announced, Pfizer withdrew its licensing application from EMA for the licensing of the Humira biosimilar.

In a letter to EMA, Pfizer said it was withdrawing its application because of a change of strategy, which was unrelated to product quality or safety. Pfizer said it reserved the right to make further submissions for the biosimilar in the future.

Pfizer did not elaborate why it was withdrawing the application.

Pfizer had in the past announced positive clinical data for its biosimilar, fyzoclad, which is in Phase 3 development. The proposed drug is yet to be approved by either the U.S. Food and Drug Administration or EMA.

Pfizer’s global president, inflammation and immunology, Richard Blackburn, said they expect their adalimumab biosimilar to be an important addition to their portfolio.

The Center for Biosimilars reported that in August of this year, researchers published results showing that Pfizer’s biosimilar shared “similar efficacy, safety, and immunogenicity profiles with Humira at 26 weeks of treatment in patients with rheumatoid arthritis that has not adequately responded to methotrexate. Further results from the 78-week, double-blind, multicenter, randomized study — which involve rerandomization of patients in the reference arm at week 26 to either continue receiving the reference or switch to the proposed biosimilar, as well as a switch of all remaining patients in the reference-only arm to the biosimilar at week 52 — are forthcoming.”

AbbVie staves off Pfizer, but Humira faces more competition

While AbbVie has been able to stave off Pfizer for the moment, Boehringer Ingelheim is insisting on going ahead with a court battle, opting against a settlement. Boehringer Ingelheim wants to make its biosimilar, Cyltezo available in the U.S. as soon as possible.

A Boehringer spokesman said: “Our focus is on bringing Cyltezo to the U.S. market and we are committed to making it available to U.S. patients as soon as possible and certainly before 2023.”

It has also been reported that several biosimilars have been introduced into the European market at discounted rates.

In October, Amgen, Sandoz and Biogen launched biosimilars in Europe, while Momenta and Fresenius Kabi are expected to launch their versions as soon as they get EMA approval. The Nasdaq website estimates that with such direct competition could erode AbbVie’s $6 billion global market.

In the face of growing competition, AbbVie has been quick to try and ring-fence Humira, its top  selling drug, with sales of $18 billion. Humira, which is approved to treat rheumatoid arthritis and other autoimmune disease, contributes 65 percent to AbbVie’s total sales.

AbbVie has struck similar licensing deals with six other companies that have made biosimilar versions of Humira, to protect its U.S. revenues from the drug. The companies are Amgen, Samsung Bioepis/Merck, Mylan, Fresenius Kabi, Momenta and Sandoz, a division of Novartis, all of which have also agreed to launch their products in the US in 2023.

In the first nine months of 2018, Humira sales reached $15 billion, a 9.5 percent jump from the corresponding period in 2017.

AbbVie expects Humira to generate about $21 billion in 2020, but the company worries that copycats could reduce its future revenue growth. Dermatology and gastroenterology markets are the strongest drivers of Humira’s growth.

The company says protect itself from competition, it was investing in new drugs in therapeutic areas like cancer and autoimmune diseases. AbbVie hopes that the new drugs will contribute 30 percent of sales by 2020 and will offset lost Humira sales over the next decade.