The future of biological therapy: a pathway forward for biosimilars

Biologicals are advanced prescription drugs to treat cancer, rheumatoid arthritis HIV/AIDS, multiple sclerosis and other debilitating diseases. In November 2010, the US Food and Drug Administration (FDA) began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics in the US or biosimilars. As FDA moves forward in implementing this pathway, it is essential that all stakeholders work together to ensure patient safety remains the top priority to achieve safe and efficacious patient care. Keywords: Biologicals, biosimilars, FDA guidelines, patient safety, pharmacovigilance