How Do Biosimilars Differ from Generics?


Ron Lanton III, Esq., President, True North Political Solutions, discusses the significant differences between biosimilars and generic drugs.

Lanton: Biosimilars are completely different from generics. First off, generics are chemically-based. They’re used a lot for maintenance medications and sometimes to cure but mostly for maintenance medications. They use small molecules, which is different from biosimilars. They don’t have a lot of clinical trials or at least as much as biosimilars do. And they’re exact copies of the brand product they’re duplicating.

A biosimilar is different because it’s not made from a chemical substance, it’s made from living proteins or living cells.

Second thing, because it’s so different, you have different storage and handling requirements. You don’t really have that stringent of storage and handling requirements for generics. Another thing that’s interesting about biosimilars is that the Black Box warnings are a little bit more intense.

The biosimilars are a lot more costly than generics, so they do cost a lot—a lot of different things involved with the manufacturing process.

There’s litigation with both, but litigation is a little different here because biosimilars have so much more they have to prove to the FDA in order to get approved as a biosimilar. Then, they need all of this manufacturing information from the biologic and there’s tension between that, so that’s not going to happen. There’s a lot of litigation on that.

So, those instances show there’s a pretty distinct difference between the two.

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