[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...