[steelframe]

Through the years I've seen dozens and dozens of "cures" for "MS" in mice (I put MS in quotes because, at this point, I've grown skeptical that the induced encephalitis mouse model is all that helpful in predicting drug performance for humans with MS). The closest thing we have to a "cure" is actually a medication that's been on the market for a while, but it was used to treat certain types of blood cancer before they discovered that it works really well for MS too.

It's now available generically: Rituximab. There's another hack that Genentech was able to patent and approve for MS to produce Ocrelizumab, which does the same thing as Rituximab but costs an order of magnitude more. Because that's how the world of big pharma works.

In essence, wiping out your plasma cells (a.k.a. B cells or lymphocytes) seems to stop MS in its tracks. Where my neurologist would typically see 2 or 3 new lesions in any given patient per year, instead now my neurologist is seeing 2 or 3 new lesions per year in the population of all their RRMS patients who are on Rituximab (or Ocrelizumab). And it turns out the immune system can get along pretty well with all the other cells types it has, such as T cells.

[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...

[loceng]

Fetal stem cells also apparently can stop degeneration from MS abd regress it (heal the damage) if disease progression hasn't damaged the body's healing mechanisms too much; emcell.com