What is a biosimilar, exactly?

Stat News

5 February 2019 - They’re meant to save money for the health care system, carve into pharma’s profits, and finally rid your television of some annoying commercials. But what are biosimilars, and where’s the revolution they were promised to bring?

In short, biosimilars are cheaper versions of blockbuster drugs that can be sold as soon as those blockbusters lose patent protection. They’re conceptually similar to generics — the low-cost pills available in pharmacies around the world — but with a vastly important distinction: Biosimilars mimic biologic drugs, which are crafted from living cells, and that means they’re not technically identical the way off-brand atorvastatin is identical to Lipitor.

That’s where the “similar” part comes in. And it also explains why biosimilars, once expected to save the system billions, haven’t taken off in the U.S. The process of making a biological treatment is considerably more complicated than churning out a pill, and all that complication makes for a murky patent situation.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Biosimilar