Sarah Yelenich, PharmD
The word “same” is on repeat in the FDA’s definition of biosimilars. Compared with the reference product, biosimilars must be given via the same route of administration; have the same strength and dosage form; have the same potential side effects; and provide the same treatment benefits, according to the agency’s latest guidance document.
Although those concepts do apply to the 10 biosimilars for adalimumab (Humira, AbbVie) that have