The U.S. biosimilar market is coming of age under the BsUFA II agreement, but there are a few steps the FDA could take to help it develop more predictably. For starters, the agency should conduct pre-approval inspections earlier in the 12-month biosimilar review cycle to give sponsors time to address unexpected issues, industry representatives told the FDA Jan. 27 in response to an independent interim assessment of the enhanced transparency and communication processes included in the current user fee agreement.