What Are Biosimilars?
Biosimilars are highly similar to an already-approved biological product. Biological products (including biosimilars) are typically made from living organisms. Biological products may be generated from various sources, including human, animal, bacteria, or yeast origins.
Unlike generics, which have the same active ingredient and are equivalent copies of a reference medicine, biosimilars aren’t exactly like their reference biologics. Biosimilars are generally less expensive than their reference medicine, and they provide another treatment option for patients. Biosimilars must undergo a thorough evaluation to ensure safety, quality, and effectiveness before they receive approval, and the FDA only approves biosimilars that have no clinically meaningful differences from the approved reference product.