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Retirely in The things you own end up owning you,

The word you’re going to be hearing in both pharmaceutical circles and investment circles in the next few years is “biosimilars”. And that’s a good thing

I’m pretty sure that’s at least two grade levels above Sarah Palin’s educational max.

Unless they’re too cheap compared to what they replace. Then nobody will develop or market them without the profit motive. Gotta love the free market. It’s still a significant markdown from what, until now, has been a purely brand-name market.  Plus, of course they have to make some money on it – the biogenerics companies employee hundreds, if not thousands of people, many of them highly educated and who certainly don’t want to work for free.  Add in that the development cost of even the generic version is probably ballpark $50-100M, they can’t just give it away.

Any approved biosimilar has been shown, through major clinical studies, to have no clinically meaningful differences in terms of safety and effectiveness.  They are hardly cheap knock-offs – the biosimilar company has likely spent $50M+ to get approval for their product.  Differences here are entirely confined to non-active areas.

These effectively are generics, just of a different type of drug.  Most generics are small molecule, while these  are “large molecule” biologics:

Intellectual property right are the same – any patents to these drugs must likewise be novel and non-obvious.  However, since the process for making these drugs is hugely more complicated, there are a lot more potentially inventive aspects to making them, hence, more IP.

They are considered “similar” instead of “identical” because through the process of making them, they may end up with insubstantial differences – briefly, molecules of that size have both active and inactive components, and the inactive components may vary.  It’s more of a terminology thing.  According to FDA: “A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.  Only minor differences in clinically inactive components are allowable in biosimilar products.”