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The Issue

Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis, MS, HIV/AIDS and other debilitating diseases. In November 2010, the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars.

As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority. We aim to provide information on the safety and quality of biologics, advocate for policies that keep medical decisions between patients and physicians, and seek solutions that ensure affordability and accessibility of biologic medications while never compromising on patient safety.

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