BI to Investigate Interchangeability for Biosimilar Adalimumab

Boehringer Ingelheim (BI) announced today that it has enrolled its first patient in a study to demonstrate interchangeability of its biosimilar adalimumab candidate, BI 695501, with the reference adalimumab (Humira).

The study will compare the pharmacokinetics (PK) 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 the biosimilar. The study’s secondary endpoints, in keeping with FDA guidance on the demonstration of interchangeability, will include safety, efficacy, and immunogenicity. BI expects results from the study to be available in the second half of 2019.

Ivan Blanarik, senior vice president and head of therapeutic area biosimilars for BI, said, “The initiation of this study reinforces our commitment to improving the lives of patients suffering from serious chronic or life-threatening diseases through biosimilars. With biosimilars, we will have the opportunity to expand treatment options while at the same time providing value to the healthcare system.”

BI’s biosimilar candidate has been accepted for regulatory review by the European Medicines Agency and the FDA, and phase 3 results demonstrating the clinical equivalence of the drug to its reference in patients with rheumatoid arthritis (RA) have been published.

This is the first study to investigate an interchangeability designation for an adalimumab biosimilar. Experts continue to disagree on whether biosimilar manufacturers would seek interchangeable designations for their products—while some have held that pursuing interchangeability would present too high a financial burden on biosimilar manufacturers to be worthwhile, others have stated that patient populations will not begin to transition to biosimilars until interchangeability for such drugs has been granted by the FDA.

The FDA’s draft guidance stipulates that interchangeable status will only be granted if the risk, in terms of safety or diminished efficacy of switching between the reference product and the biosimilar, is not greater than the risk of using the reference product without a switch. The agency also says that it expects manufacturers seeking interchangeable status to include data from switching studies, conducted in sensitive populations, that include at least 3 switches. The agency indicates that, if data support interchangeability in 1 indication, the sponsor could provide scientific justification to support extrapolation of interchangeability to other indications.

The FDA is alone among global regulatory bodies in requiring 3 switches between biosimilars and reference products, and a recent study has pointed to that fact as responsible for creating a lack of switching data in available medical literature. Thus far, only 53 switching studies have been identified, and immunogenicity data have been provided in just 51% of those studies. BI’s study on the interchangeability of its adalimumab biosimilar with the reference product has the potential to improve clinical understanding of switching, and could contribute to greater physician, pharmacist, and patient acceptance of biosimilars.