Biologics are medicines extracted from a variety of natural sources—human, animal or microorganism—and include a wide range of products such as vaccines, blood components, gene therapy, tissues, and recombinant therapeutic proteins. In contrast to traditional small molecule prescription drugs that are chemically synthesized, biologics are large molecule products that involve complex research, development and manufacturing processes. Biologics represent the cutting-edge of biomedical research and often offer the most effective treatment for such serious and life-threatening conditions as cancer, HIV/AIDS, rheumatoid arthritis and heart disease. However, biologic medicines can cost thousands of dollars per treatment keeping them out of reach for many patients.
Biosimilars are biologic medicines that are approved for use based on data showing they are highly similar to an existing brand name biologic, known as the reference product. Biosimilar manufacturers must prove that their biosimilar product has no meaningful clinical differences in terms of safety and effectiveness from the reference product. Some biosimilars can be designated as “interchangeable” with the reference product, meaning they can be substituted for the brand name biologic by a pharmacist without the intervention of the prescribing health care provider. Biosimilars typically can be approved and licensed for use after expiration of the exclusivity period granted to the brand name product. Because biosimilar approvals can rely, in part, on information attained from the original reference product, thereby diminishing the need for repeating extensive new drug clinical trials, they are less costly than the brand biologic. Consequently, biosimilars offer safe, effective, and more accessible treatment alternatives for patients needing biological therapy. In an environment where health decisions increasingly are made based on value and cost, biosimilars will play a vital role in improving patient access to needed medicine. The launch of new biosimilars over the next decade will expand treatment options for chronically ill patients and allow greater use of biologic medicines overall by providing more affordable access to individuals who in the past have either forgone treatment or settled for less effective medicine.
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