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Cate Lockhart, PharmD, PhD: Biosimilar vs Generic Markets


Cate Lockhart, PharmD, PhD, discusses the similarities and differences in the biosimilar and generic markets.


How does the biosimilar market compare to that of generics?

Certainly, with the regulatory pathway, to me, that’s where it diverges. Beyond that, I don’t see it as really being divergent. If you think about biosimilars— if they are approved as a biosimilar– that means they are significantly similar. It’s not identical, you know, because it’s a biologic, but it needs to be substantially similar and [have] no clinical difference.

In a sense, in spite of the regulatory process, there’s no evidence of any clinically meaningful difference. In that sense, the divergence really is post-regulatory, in my opinion, where it’s a matter of education among prescribers, patients, [and] payers, but then in the United States that’s not really the hurdle for utilization.

So, I don’t know that this necessarily diverges from the generics scenario other than it is certainly a scenario that we did not fully appreciate would come to pass in that, the reason for slow uptake in the United States is not wholly because of concerns about safety and effectiveness. It’s more tactical on the part of pharmaceutical companies— these are business decisions, this is a business– and that’s perfectly fine. But, the effect is creating a marketplace where even though we now have 11 approved [biosimilar] products in the US, only 3 are currently on the market.

That’s a place where it diverges from generics in a way, although, we did see similar problems with generics [such as] slow uptake of generics back in the day because of the uncertainty.

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