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Dr Fran Gregory: What Can We Learn From Biosimilar Use in Other Countries?


Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how the use of biosimilars in other countries strengthens the acceptance and approval of these products in the United States.

Continuing research and education awareness of the efficacy and safety of biosimilars is necessary in the United States, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health.


What lessons can specialty pharmacists learn from other countries' experiences with increasing adoption and trust in biosimilars for Humira (adalimumab) and Stelara (ustekinumab)?

The United States is without any doubt somewhat behind other countries in the uptake and the acceptance of biosimilars. We all know that tender systems are much more effective in converting products close to 100% to a biosimilar, and this has been done in many European countries, and there are many studies representing the success of those programs.

When we think about the US system, obviously, we talked about rebates, we talked about formularies, we talked about incentives that aren't necessarily always aligned to the lowest-cost option for patients. If we think about what we can learn from other countries, it really is thinking again about that big picture, what are we trying to accomplish here. As health care providers and as a country, we're trying to get to improve patient access and a lower-cost alternative for a patient. Other countries have been very successful at that.

The other thing that I think about when I think about what we can learn from other countries; Hillel Cohen [PhD, executive director of scientific affairs at Sandoz,] recently did a really nice study of all of the biosimilar-to-biosimilar switching publications and analyses out there. He wanted to evaluate the biosimilar-to-biosimilar switching and is it safe; is it effective? Are there additional safety concerns or immunogenicity concerns, other things we need to be worried about when we start thinking about biosimilar-to-biosimilar switching?

A very high number of patients have experienced biosimilar-to-biosimilar switching, and this is a result of either a formulary change or a change in tender selection for certain countries that have a tender system. Those patients had experienced no greater adverse events, the same efficacy, and no change in immunogenicity from either the reference product or a biosimilar-to-biosimilar switching.

I thought that was interesting learning from again, mostly European countries, who have tender systems where they do convert patients very, very effectively. And that is a concern still in the US that we hear: Is it safe to change from one biosimilar to another? And pharmacists do think about that. We think about the safety of our patients, and we want to make sure that they get the best treatment that's most appropriate for them.

I think that we have in the biosimilar world people who study these things and trust the science and the real-world evidence that biosimilar-to-biosimilar switching is not a concern. But that is another myth that we'll have to get kind of over in the United States and make sure that we continue to educate and reassure pharmacists, physicians, all health care providers, and patients that biosimilars are a very safe, cost-effective option for a reference product.

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