what are biosimilar drugs

11 months ago 32
Nature

Biosimilar drugs are biological products that are similar to a reference biologic, which is usually the original product, and for which there are no clinically meaningful differences in safety, purity, and potency. They are almost identical copies of the original product, but are manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured. Unlike generic drugs, which are exact copies of their brand name counterparts, biosimilars are not exact copies of their reference biologics, but they mimic the active ingredient in the reference biologic. Biosimilars are used to treat many chronic and severe conditions, including chronic skin diseases, chronic bowel diseases, diabetes, macular degeneration, and arthritis. They are safe and effective treatment options for many illnesses and can increase access to lifesaving medications at potentially lower costs. Biosimilars are made from the same types of sources, such as living cells or microorganisms, as their reference products and are just as safe and effective as their reference products. However, the development of biosimilars is difficult and costly because biologics are derived from living organisms that are genetically modified, and biosimilars must maintain consistent quality and clinical performance throughout their lifecycle.