The first biosimilar was authorized for sale by the European Union in 2006. Since then, the number of authorized biosimilars has increased worldwide, and they are expected to play an increasingly important role in healthcare.
A biosimilar is a biologic drug that is highly similar to a biologic drug that was already authorized for sale (reference drug). There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the reference biologic. It’s important to remember that biosimilars are not the same as generic drugs. Biosimilars are up to 1,000 times the size of small molecule generic drugs, and are far more structurally complex.
Typically, there is a lower cost of development for a biosimilar than that of its reference biologic. Therefore, they can be offered at a lower cost which can help reduce the financial impact of medications on the healthcare system. Plus, it can help provide more treatment options for potentially deadly diseases.
The clinical testing requirements for biosimilars differ from those of the reference product. Still, biosimilar manufacturers must submit robust data, such as extensive analytical studies, plus nonclinical and clinical evidence. This totality of evidence is required before a biosimilar is authorized for sale.
Reference biologics and biosimilars biologics are both available in Canada. Amgen is a worldwide leader in the development and manufacturing of biologic medicines. We are proud to apply our scientific expertise to expand the options available to Canadian patients.