Switching Study Complete, Biosimilar Maker Awaits FDA Decision on Interchangeability

In an April 23 press release, Boehringer Ingelheim announced that its phase 3 switching study between its biosimilar Cyltezo® and the reference adalimumab biologic Humira® is complete. The biosimilar maker also stated that it had filed its supplemental application for interchangeability designation with the Food and Drug Administration (FDA).

The VOLTAIRE-X study randomized 238 patients with moderate-to-severe plaque psoriasis to receive either the 40 mg/0.8 mL dose of the originator product or Boehringer’s biosimilar. The study met the requirements to support interchangeability by employing multiple switches between the two products in addition to cohorts who received one agent continuously. The manufacturer is presenting its 32-week results at the 2021 virtual meeting of the American Academy of Dermatology.

The study found that clinical efficacy, pharmacokinetics, immunogenicity, and safety outcomes were similar among the patient cohorts switched between biosimilar and reference products, and those who received continuous treatment with Humira.

The VOLTAIRE-X study was initiated in July 2017 and slated to end in April 2019. Our previous communications with Boehringer Ingelheim hinted at ongoing talks with the FDA to better optimize their chances of gaining interchangeability. However, the 32-week primary outcome results are only being reported now.

The decision by the FDA on Cyltezo is expected in the fourth quarter of 2021. For the first time, the FDA has been asked to conclude whether the interchangeability designation should be provided. When contacted by BR&R, Boehringer Ingelheim representatives could not further specify the decision date.

Cyltezo is expected to launch in July 2023, making it the third biosimilar to become available among manufacturers signing settlement agreements with AbbVie.

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