Biologic and Biosimilar Regulation

Biologics are complex medications made from living organisms, used to treat various diseases. Because they are intricate and sensitive to changes, their development and approval are strictly regulated to ensure safety and efficacy. Biosimilars are versions of biologics that are highly similar but not identical. While they must demonstrate comparable quality and effectiveness, they are typically less expensive. In pharmaceutical law, regulations ensure that both biologics and biosimilars undergo rigorous testing and evaluation by agencies like the FDA, providing patients with safe treatment options while fostering competition in the market.