Rheumatology Expert Says Patients Should "Feel Comfortable" With Biosimilars

This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.

Dr Cohen, who recently authored a study on ABP 501 (Amjevita), a biosimilar adalimumab (Humira), told The Center for Biosimilars® that he does not expect patients switching to biosimilars from reference drugs to experience difficulties. “Clinical trials have shown equivalent benefits, safety, and immunogenicity,” said Cohen. “We’re also comforted by the fact that the Europeans have had these drugs now for several years, and have looked at switching…and in general, switching is not associated with an increased dropout rate or a loss of efficacy. So that, combined with clinical trials which look at a single switch—a switch from the originator to the biosimilar—from a scientific perspective, gives me great confidence.”

While Cohen is wary of taking patients off therapies that are working to control disease activity, he says, “I think we can reassure patients that, if we face that situation due to non-medical substitution by the formularies of insurance companies, I think they will do well. If there’s going to be tremendous cost savings, that’s a discussion we can have with the patient.” He does have lingering concerns about the possibility of multiple switches among various biosimilars once more drugs enter the market, however. “There are going to be multiple biosimilars available to insurers and PBMs [pharmacy benefit managers] to pick from” says Cohen, “And they go from one to the other and whatever’s cheaper. We don’t know what’s going to happen to patients after multiple switches occur. We still believe we’ll be okay, but it remains to seen.”

However, in his own experience, Cohen has not had to transition patients from reference biologics to biosimilars because of formulary changes. “We keep waiting for Inflectra or [Remicade] to really begin to make an impact on the marketplace,” Cohen says, but “so far, there’s very minimal cost saving to be accrued by the infusion centers…we have not faced that yet. Very few of us have experience with biosimilars other than in clinical trials.” He points to the European experience as the primary venue for switching thus far, saying, “The best examples of where switches have occurred have been in Denmark and Norway, where the government has mandated that a switch will happen.”

Looking toward the future, Cohen does not see a strong reason to believe that the United States will follow in Europe’s footsteps with respect to switching to lower-cost biosimilars. “In the United States, where we’re dependent on insurance companies and on Medicare, I don’t know if we’ll see greater access for patients.”

While the lower prices of biosimilar drugs could conceivably reduce the burden of high-cost therapies on health plan members, Cohen is not sure that the savings will be passed along to patients. “It’s our hope…but, there’s no guarantee that insurance companies will lower our premiums. Will we see a stabilization of rates in insurance plans? That would be our hope. Will we see greater access for patients? That would be our hope. But I’m not sure either of those will be achieved in countries like ours.”

In order to stimulate biosimilar uptake, Cohen has suggestions for insurance companies: “The only reason to use a biosimilar is because it’s cheaper…I don’t think patients will switch unless there is a tremendous cost savings available. I think that [price] reduction is going to have to be substantial, probably in the range of 30% to 50%, for a patient to be willing to switch.” He also hopes to see insurers reduce the burden on clinicians who prescribe biosimilars rather than reference drugs. “We could envision where a patient goes on a biosimilar, and we don’t have to spend the time and effort that we currently do to get a drug approved [by the health plan]. There has to be some give and take…for the maintenance of the healthcare system.”

If biosimilars for rheumatic diseases do gain significant traction with insurers, Cohen wants patients to know that “They should feel comfortable that the regulatory authorities have evaluated these molecules with a robustness…and we should not see significant differences in benefit to the patient.”