Is a Window of Opportunity Closing for US Biosimilars?

In a climate of growing scrutiny of potential “pay-for-delay” patent litigation settlements, as well as antitrust lawsuits related to settlements concerning AbbVie’s blockbuster Humira, drug makers have been pushing back against suggestions that settlements made between biosimilar developers and AbbVie are harming competition in the United States.

For example, the Biosimilars Council, a part of the Association for Accessible Medicines, wrote in a white paper in June that these settlements with AbbVie—none of which will allow a biosimilar adalimumab to reach the US market before 2023—are pro-competitive in nature because they will allow biosimilars of the blockbuster therapy to reach US patients 11 years earlier than would otherwise be possible.

But not all stakeholders agree with that perspective, and this week, writing in a viewpoint in JAMA, Walid F. Gellad, MD, MPH, and Chester B. Good, MD, MPH, both of the University of Pittsburgh, argue that the deep cost savings achieved in Europe for biosimilar adalimumab are unavailable to the United States because of those very settlements struck between AbbVie and the developers of all FDA-approved biosimilars.¹

By the time biosimilar adalimumab can launch in the US market, Gellad and Good write, orally administered treatments—even oral biologics—could plausibly have overtaken Humira in terms of market share, muting the effect of biosimilar entry.

If patients with inflammatory disease who currently take Humira are able to transition to more convenient options (like AbbVie’s small-molecule drug, upadacitinib) or more effective treatment options (like AbbVie’s risankizumab), they may not want to switch back to injectable adalimumab, despite the potential for reduced cost with biosimilars.

The authors predict that AbbVie will incentivize switching to its new, patent-protected agents “long before” biosimilar adalimumab becomes available, helping to ensure the company’s continued hold on the market for inflammatory diseases. They even suggest that an orally administered version of adalimumab may not be far off, which would further incentivize patients to remain on an AbbVie product rather than transition to a biosimilar.

All of these factors raise the question, say Gellad and Good, of whether the window for biosimilars to make an impact in the US market is closing.

“The example of adalimumab, including its biosimilar delay, injectable competitors, and now oral biologic competitors, should be a warning that speed is of the essence for establishing a robust biosimilar market in the United States,” they write.

Reference

1. Gellad WF, Good CB. Adalimumab and the challenges for biosimilars [published online October 23, 2019]. JAMA. doi: 10.1001/jama.2019.16275.