3 ms·
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 compli
by pilotneko 5y ago
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/financial_reports/annual_reports/2018/our-innovation/progressing-our-science/biosimilars-vs-generics/index.html https://www.pfizer.com/sites/default/files/investors/financi...