Define biosimilar drugs.

Biosimilar drugs are defined as biologic medical products that are highly similar to already approved reference products, ensuring that there are no clinically meaningful differences in terms of safety or efficacy. This definition captures the essence of biosimilars, which are designed to replicate the therapeutic effects of established biologics.

Biosimilars undergo rigorous testing to demonstrate that any variations in manufacturing do not impact the clinical performance of the product compared to the original biologic. This similarity allows for a seamless substitution in clinical practice, helping to provide patients with access to effective treatments while potentially lowering healthcare costs.

The other choices focus on different concepts. Identical drugs refer to chemically synthesized compounds, which do not apply to biologics that are complex and variable. Drugs derived from synthetic biology imply a method of creation rather than their relationship to existing products. Finally, medications for niche markets do not inherently define the biosimilar category, as biosimilars are intended to provide accessible alternatives for broader populations rather than being limited to specialized markets.