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On April 23, 2021, Boehringer Ingelheim announced results from the VOLTIRE-X Phase III randomized study that evaluated switching patients with moderate-to-severe chronic plaque psoriasis between reference product Humira® (adalimumab) and biosimilar Cyltezo® (adalimumab-adbm).  32-week data will be presented at the American Academy of Dermatology 2021 meeting.

According to Boehringer Ingelheim, the results of the study support its application for interchangeability between Cyltezo® and Humira®, which has a proposed action date of the 4th quarter of 2021.  If approved, Cyltezo® will be the first interchangeable product licensed in the U.S.  Cyltezo® was approved as a biosimilar by the FDA on August 25, 2017, but is not currently marketed.  Under a licensing agreement with AbbVieCyltezo® will be commercially available in the U.S. starting on July 1, 2023.

In order to receive an interchangeability designation, the FDA requires that a biosimilar be “expected to produce the same clinical result as the reference product in any given patient” and “not present greater risks in terms of safety of diminished efficacy from alternating or switching” between the biosimilar and reference product.  Once a product receives an interchangeable designation, pharmacists will be allowed to automatically substitute the originator product with the interchangeable (subject to various requirements under each state’s laws).

According to Boehringer Ingelheim’s press release, VOLTAIRE-X is a Phase III study in 238 patients, randomized to assess:

  1. Pharmacokinetic similarity between patients with moderate-to-severe chronic plaque psoriasis receiving Humira® (40mg/0.8mL) continuously versus those who switched several times between Cyltezo® and Humira®
  2. Comparison of the efficacy, immunogenicity, and safety profiles between patients receiving Humira® continuously versus those who switched several times between Cyltezo® and Humira®.

Patients with moderate-to-severe chronic plaque psoriasis received Humira® and were then randomized to ‘switching’ or ‘continuous’ treatment.

While to date no interchangeables have been approved in the U.S., Mylan and Biocon previously announced submission of “all necessary documentation” to the FDA for approval of Semglee® (insulin glargine) as a biosimilar and interchangeable of Sanofi’s Lantus® (insulin glargine).

 


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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