European Commission Grants Marketing Authorization For BI's Adalimumab Biosimilar

Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission (EC) to treat multiple rheumatic diseases, after having received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2017.

The approval “…marks a significant step forward for us in offering effective and more affordable treatment options for patients with chronic inflammatory diseases,” said Ivan Blanarik, senior vice president and head of therapeutic area biosimilars at BI. “We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world,” he added.

Cyltezo's marketing approval comes on the heels of last week’s announcement of 1-year data from BI’s VOLTAIRE-RA trial, which showed that the biosimilar had no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference Humira in patients who had moderate to severe RA.

In addition to earning the EC’s marketing authorization, Cyltezo also gained FDA approval in August 2017. Currently, it is unclear when the drug may reach the marketplace, as BI is currently engaged in patent litigation with AbbVie.

While litigation continues, BI is undertaking an interchangeability study for its drug in an effort to gain an FDA designation of interchangeability with the reference Humira. BI’s study will compare pharmacokinetics and clinical outcomes of 240 patients with moderate to severe chronic plaque psoriasis who receive the reference adalimumab continuously versus patients with the same diagnosis who switch multiple times between the reference and Cyltezo.

While the FDA has not yet finalized its guidance on demonstrating a biosimilar’s interchangeability with its reference, the agency’s draft guidance holds that interchangeable status will only be granted in cases in which the risk (in terms of safety or diminished efficacy) of switching between the reference and the biosimilar is no greater than the risk of using the reference product alone. The agency expects manufacturers seeking interchangeable status to include data from switching studies, conducted in sensitive populations, that include at least 3 switches.