Though the definition is not comparable, we could say that a biosimilar is the ‘generic’ of the biologic of reference. Nevertheless in no case the ‘generic’ term must be used to refer to a biological agent. A generic drug is a chemical compound with an identical formulation that the original formula. The only difference is the excipient that shapes the product (see generics in another part of this blog). A biosimilar, is an extremely complex protein, of great molecular size, which has efficacy and safety similar to the product of reference. As an example, Remicade (Infliximab) has already on the European market and in other countries a biosimilar, with two different trade names, Remsima and Inflectra. To approve a biosimilar is required to carry out pre-clinical tests and face to face clinical trials against the product of reference. Pre-clinical tests and efficacy and safety must be comparable to the reference product. Biosimilars only can be launched once the product of reference has lost its patent, which should occur ten years or more, depending on the Country, after being in the pharmaceutical market. The main advantage of biosimilars is the price. Is estimated that they will be between 30 to 50% cheaper than the original product. In the next 10-15 years, the hypothetical success of biosimilars will depend on several factors. Among them, the country policy in heath care can be very relevant. In Spain, for example, a country with a strong Public Health Care System, in which, the State pays biologics through the citizens taxes, the government might decide buying only biosimilars instead the reference product. Another possibility is that the Pharmaceutical Company that produces the original product decides to reduce the price to the levels of biosimilars. Nonetheless, we’re at the beginning of a new era, with only one biosimilar approved, and to speculate about what will happen with biosimilars might be confusing. At the present, we still have more questions than answers.
Definition of Biosimilar by the EMA (European Medicines Agency): A biosimilar is a medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise
Definition of Biosimilar by the FDA (USA):
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.