Sandoz's Biosimilar Adalimumab, Hyrimoz, Authorized by European Commission

Biosimilar developer Sandoz announced today that the European Commission (EC) has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.

"We believe in making access happen for patients who are suffering from chronic inflammatory diseases. Earlier and expanded access to important, disease-modifying, biologic medicines can fundamentally change how patients manage their health," said Stefan Hendriks, global head of biopharmaceuticals, Sandoz, in a statement. "Biosimilars such as Hyrimoz can also play a transformational role in healthcare system sustainability—so we look forward to making Hyrimoz, and other important biosimilar medicines, broadly available."

The authorization follows a positive opinion on the drug adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2018. As part of its regulatory submission package, Sandoz submitted data the product that included findings from the phase 3 ADACCESS study in patients with moderate to severe plaque psoriasis. Results of the study, which were presented at the American Academy of Dermatology Annual Meeting in March 2017, demonstrated that the biosimilar had similar efficacy to the reference Humira; after 16 weeks of treatment, 67% of patients receiving the biosimilar achieved a 75% improvement in their symptoms (as measured by the Psoriasis Area Severity Index) versus 65% of those treated with the reference product. The biosimilar’s safety profile was also similar to that of the reference.

While the biosimilar has now cleared its final regulatory hurdle in the European Union—joining Cyltezo, Imraldi, and Amgevita in having gained the EC’s authorization—it remains to be seen when the drug, which has also been submitted to the FDA for regulatory approval in the United States, may be able to launch. AbbVie, maker of the reference Humira, has reached settlements with 3 biosimilar developers who hope to launch their competitive product.

Most recently, Mylan settled with AbbVie over US rights to sell an as-yet unapproved biosimilar. That deal followed shortly after AbbVie settled with Samsung Bioepis over Imraldi in a deal that had similar terms to that of its first agreement with Amgen over Amgevita. None of the deals permit US sales of adalimumab biosimilars prior to 2023, or European sales prior to October 2018.

AbbVie’s unique strategy to grant licenses to biosimilar competitors has raised ire in the United States, and lawmakers are now calling for investigations to be launched into these settlements and introducing legislation that could make it more difficult for such agreements to move forward in the future.