Talk to your health care provider about the medications you are prescribed or are taking. Often, biological medications, including biosimilars, are given in a hospital or an infusion center. Talk to the doctor or nurse who is giving you the treatment. If you have a prescription, your doctor or pharmacist can tell you what you are prescribed and what you are given at the pharmacy.
Biosimilars and generics are approved through different abbreviated pathways that avoid duplicating certain costly clinical trials. Both biosimilar and generics go through a rigorous review process. Once FDA-approved, these medications are just as safe and effective as the reference products they are compared to. But, there are differences between biosimilars and generic drugs. For example, biosimilars are generally made from natural and living ingredients and generics are often made from chemical ingredients.
In contrast to a chemical, which is synthesized and can be generally copied, a biologic medication is made from natural and living sources and cannot be exactly copied. So, the information needed to demonstrate that a biologic is biosimilar to another biologic can be much more extensive than what is needed for a generic.Reducing costs is one reason Congress created the FDA approval pathway for biosimilar medications.
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