Biosimilars Safety & Efficacy

Safety and efficacy are of the utmost importance when considering medical treatment. Biosimilars undergo the same level of rigorous regulatory review as their reference biologics. This means that even though it is not identical to the reference biologic, a biosimilar is highly similar to, and has no clinically meaningful differences in terms of safety and efficacy from, its reference product.1

Prescribe with Confidence

Healthcare professionals must be confident in the treatments they prescribe to their patients. It is important for both the patient and the healthcare professional to feel secure that these treatments are safe and efficacious and that any adverse event can be identified and tracked quickly and accurately. All biosimilars undergo strict comparative analytical, nonclinical, and clinical evaluations prior to market approval — all to verify that there is no unanticipated variation in potency, quality, efficacy or safety – and ensuring healthcare profressionals and their patients can can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.1

Patient, physician, pharmacist and payer confidence in biosimilars requires scientifically appropriate regulatory standards.


  1. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. 2015.