[pilotneko]

Just noting that -mab therapeutics are not synthesized directly, they are produced in cloned cell lines. It’s practically impossible for one pharma company to replicate another companies -mab, since they will never have access to the exact cell line used to manufacture the original. Also, Rituximab hasn’t been fully characterized, hence the discovery of new uses. There is no such thing as generic when it comes to -mab therapeutics.

Point is, the cost to create Ocrelizumab may be legitimately higher than Rituximab.

[therein]

Interesting point raising regulatory questions for sure.

Should the government compel drug companies to share their cell lines to preserve the same market dynamics as generic drugs once a monoclonal antibody line product hits the timeline to go generic?

After all, otherwise it would be somewhat similar to a drug company rejecting to share the chemical synthesis pathway and precursors saying "an ex-employee built this chemical synthesis machinery and we just put the raw ingredients and comes out the drug from the other end".

But I am guessing for generic drugs, the generic manufacturers are expected to come up with their own synthesis pathway anyway and the original manufacturer has no obligations to help.

[pilotneko]

Well, that’s the thing, you can’t make a generic version of these drugs because you can’t fully characterize the structure. They are just way too big and complicated, which is scary because a single difference in a glycosolation site can induce an extreme immunogenic response.

Best the FDA can do is allow biosimilars and subject them to significantly more testing, which increases the cost 100x (compared to a traditional generic).

https://www.pfizer.com/sites/default/files/investors/financi...