What are Biosimilars?
Biologics are medicines produced from living organisms. For over three decades, biologics have been used to treat patients with challenging illnesses and autoimmune disorders. Biosimilars are biologic medicines that are developed to provide safe, effective alternative versions of existing biologic medicines with scientifically comparable quality, safety and efficacy.1 A biosimilar must show that it has no clinically meaningful differences in terms of safety and effectiveness from the existing biologic medicine, known as a reference product.
Why Biosimilars Matter
Biosimilars foster competition and tie to projected healthcare system savings. This competition is essential because for many patients, the availability of a high-priced brand biologic for their particular condition does not necessarily mean that they will have access to the therapy. By introducing competition into an arena that has historically been essentially free from competition, biosimilar medicines will offer choices at more affordable prices. The availability of biosimilars could translate into major savings for patients, taxpayers, insurers and providers.
In addition, many believe that competition will motivate owners of patent-protected medicines to develop new, innovative products. Driving the circle of innovation in healthcare is always a major benefit to patients.
Strict Approval Pathways
Biosimilars have been approved in highly regulated markets such as the US, EU, Canada, Australia and Japan. The regulatory pathways are strictly defined on the basis that the biosimilars have demonstrated comparability, or high similarity, to the reference biologic product.
The final product is analyzed with some of the most sophisticated and innovative pharmaceutical technology available today and assessed by FDA medical experts.2
To learn more about biosimilars visit: the Generic Pharmaceutical Association’s (GPhA) biosimilars website and The Biosimilars Council website.
1 The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products, The Biosimilars Council, A Division of GPhA, page 6.
2 The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products, The Biosimilars Council, A Division of GPhA, page 6.
Last Updated 1/4/2016