Much discussion at the Business of Biosimilars conference today about the evils of evergreening. Purity, potency and safety? Feh.
Other topics of heated debate centered around whether or not “biobetters” would always precede biosimilars (most thought so) and whether or not that was a good thing. (Different points of view depending on whether you’re looking at it from a developer, payer or provider standpoint. (Hint – there weren’t any providers in the room.)
And there seemed to be general consensus that, with a clear FDA pathway still off in the future, BLAs are the way to go. Hence a redefinition of BLA as “Beat Legislative Ambiguity.” No aBLA biosimilar.
Badges? We don’t need no stinking badges.
Two interesting comments from Leigh Purvis (Senior Strategic Policy Advisor, AARP). The first was that the folks at AARP are concerned that “biologics will soon be used to treat paper cuts.” (Nice to reconfirm where they stand on the issue.) And the second that, while it’s important to educate AARP members about both generics and biosimilars –“there isn’t any money available in the budget.”
Draw your own conclusions.
