Are There Toxicological Differences Between Biosimilars and Reference Products?
In theory, there should be no significant toxicological differences between biosimilars and their reference products. However, due to variations in manufacturing processes, minor differences can arise. These variations necessitate careful monitoring of biosimilars post-market to ensure ongoing safety. Regulatory bodies require pharmacovigilance plans to detect any unexpected toxicological or immunological issues once the biosimilar is in widespread use.
