The FDA published a draft guidance Feb. 6 regarding biosimilars, intended to provide recommendations on, among other things, how to prepare draft labeling for manufacturers seeking licensure of a biosimilar or interchangeable biosimilar product for fewer than all of the reference product's licensed conditions of use, as well as recommendations for submitting supplements to a licensed BLA that seek to add a condition of use for which the reference product has been licensed. The draft guidance also states that, to the extent practicable, the FDA intends to target a six-month timeline for reviewing supplements seeking licensure of a biosimilar or interchangeable biosimilar product for an additional condition of use that has been previously licensed for the reference product. That would not alter the goal dates described in the BsUFA II Goals Letter, the agency said. “Issuance of this guidance is part of the FDA's ongoing efforts to support the development of biosimilar and interchangeable biosimilar products by providing additional clarity to applicants, which the FDA expects will improve access to these vital therapies for patients who need them,” said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research. Comments regarding the draft document should be submitted within 60 days of publication in the Federal Register.