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