US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.

Biden Administration’s regulatory freeze suspends HHS action to appoint an administrative dispute resolution board for the 340B program. Good news for manufacturers?

Report released as soon-to-be committee chair Ron Wyden, D-OR, assembles plans for drug pricing legislation in the new Democratic-controlled Senate.