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Suzette Kox, MPharm: Shared Biosimilar Challenges in the United States and Europe


Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses challenges faced jointly by the US and EU biosimilars markets.


I think that's the very large question, of course, but maybe let me sum up. According to our US colleagues, when I look at the United States, of course the biggest, key challenge is definitely the famous “patent thickets” linked with all the patent litigation. And the misinformation [and] scaremongering. I think scaremongering is very dangerous. When patients get information, it’s difficult to let go.

Those are very important things; even in the European Union where we have been dealing with biosimilars since 2006, we still need to continue to educate and inform. I think that’s crucial and we cannot give up on that. It has to be permanent access to information and new ways of explaining, so that’s very important.

Also, according to our US colleagues, we really need strong incentives for the United States, and incentives which are across the different stakeholder groups, and then uptake measures in order that somehow, one day, the biosimilar market takes off in the United States.

Of course, it is very complex, but maybe these are the key elements there; those who are familiar with the US environment know what I’m referring to.

With regard to the European Union, as you well know, I think we have a lot of experience. Maybe we have today with the EU approved biosimilars maybe 800 million patient days or even 900 million patient days experience. So biosimilars are accepted. They are accepted as being safe and efficacious alternative treatments.

We also have very good experience with switching. It is regarded as safe. The medical societies and medical communities are endorsing that publicly more and more.

Nevertheless, again, education has to continue. It’s never finished. There are new molecules coming out, new biosimilars, there are new treatment areas where biosimilars are first. When the first cancer biosimilar monoclonals were approved, we had to start again in those communities. It’s a never-ending approach; it’s very important.

Certainly now the key challenge for the European Union is that [while] biosimilars are broadly accepted, we need to now strike a balance between, I would say, short-term cost savings and then long-term sustainability for this industry.

It is of course very complex, but that’s what we have to look at because, I think, that’s also valid for the United States. We have to have policies in place which assure long-term sustainability for this industry. Otherwise, they will not further invest into biosimilar development.

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