Sandoz Gains European Approval for Erelzi as US Legal Woes Continue

Sandoz announced today that is has received approval from the European Commission for its biosimilar etanercept (which will be marketed as Erelzi) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, axial spondyloarthritis, psoriasis, and psoriatic arthritis.

The European Commission based its approval on analytical, preclinical, and clinical data that demonstrated biosimilarity of Sandoz’s product to the reference etanercept (Amgen’s Enbrel). Clinical trials included a pharmacokinetic (PK) study that demonstrated bioequivalence of the 2 treatments, and that did not reveal any clinically relevant differences in safety, tolerability, or immunogenicity between the biosimilar and its reference. The product’s phase 3 study, which included 3 treatment switches between the biosimilar and the reference product, met its primary endpoint of achieving an equivalent PASI 75 response rate (a 75% reduction in the psoriasis area and severity index) by week 12 of treatment, and generated confirmatory efficacy, safety, and immunogenicity data.

“Immunology is a priority for us and today’s approval of Erelzi, the second in this therapy area in as many weeks, clearly demonstrates our commitment to patients. This can also be seen in the progress we are making in our immunology pipeline with 2 recent file acceptances in Europe,” said Carol Lynch, global head of biopharmaceuticals at Sandoz.

Erelzi marks Sandoz’s 5th biosimilar approval in Europe, but the drug manufacturer faces challenges in bringing the treatment to the US marketplace. Last week, a Nobel Prize-winning researcher, Bruce Beutler, MD, of the University of Texas Southwestern Medical Center, moved to block a Sandoz subpoena seeking his testimony in patent litigation over Erelzi. Sandoz, in its ongoing fight to invalidate 2 of 5 patents asserted by Amgen for its innovator etanercept, sought to compel Dr Beutler’s testimony concerning a 1995 patent for his work on tumor necrosis factor inhibitors.

Counsel for Dr Beutler asked the court, as an alternative to quashing the subpoena, to issue a protective order that would shield him from having to offer his expert opinion about the similarity of the reference and biosimilar molecules.

While Sandoz gained FDA approval for its product in 2016, such ongoing litigation will continue to delay US patient access to the biosimilar treatment; earlier this year, Richard Francis, division head of Sandoz for Novartis, told Reuters that he expected legal delays to extend until 2018. "That's the frustration sometimes of the legal situation,” Francis said, “but the way I look at that, we're carving the landscape out as we go."