The FDA has issued new draft guidance that focuses on the availability of biosimilars. Tento rámec je druhou schémou agentúry navrhnutou na zefektívnenie vývoja biosimilárnych liekov. The goal is to reduce drug prices. Biosimilar medicines are biological medicines similar to the reference medicine, which enter the market after patent protection has expired. They are manufactured according to strict requirements for quality, safety and efficiency. Their competition with reference drugs leads to lower prices and improved patient access to treatment.