What are Biosimilars?

As most know, biologics are a medical product whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods.[1]   Biologic drugs have revolutionized the treatment of many diseases including cancer, AIDS and rheumatoid arthritis.

Biosimilars are a follow up to biologic drugs.  Patents for biologics are expiring, creating a market for biosimilars in Canada and around the world.  Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada.[2]

You will hear some referred to these products as ‘generic biologics’ however biosimilars are larger molecules than chemical generic products and therefore cannot be considered to be true ‘generics’ that can be approved without clinical trials.

Biosimilars or SEB’s are considered a copy of the biologic medical product that is similar but not the same to the original medicine.

This is a new twist on the evolving pharmacy landscape.  While biosimilars will provide some savings over the comparable biologic drug, it is not expected that it will create the same savings that generic substitution drugs did in the synthetic based drugs arena.

If you want more information on this topic, please contact your JDB Group representative or view the following resources:

What Private Drug Plan Managers Should Know About Biosimilars

Biologics and Biosimilars -A New Complexity in the World of Medicines

[1] “An Introduction to Biologics and Biosimilars.” Amgen. 2011.

[2] “Shaping the Biosimilars Opportunity.” IMS Health. 2011