Biotech Values

[DewDiligence]

But some health policy experts argue that regardless of what approval pathway the FDA establishes, generic drug companies might be better off arguing their products are entirely unique to brand-name drugs, given the long period of exclusivity that brand-name drugs have."

In general, this advice makes sense for non-substitutable biosimilars but not for substitutable biogenerics. For the latter, the vendor’s ability to ring up sales without incurring sales and marketing expenses outweighs the 12 years of marketing exclusivity conferred to a branded biologic.