Background on Biologics and Biosimilars
Biologics are large, complex medicines that are made in living cells.1 In comparison to small molecule drugs, such as Aspirin®, which have simple molecular structures and can be ingested in pill form, biologic medicines must be injected or infused into patients to avoid digestion of their intricate protein structure in the gastrointestinal tract.2 Many of the biologic therapies available that have revolutionized the treatment of inflammatory diseases in recent years target and block inflammatory cell signalling molecules (cytokines) and immune cells.3
Upon patent-expiry of an innovative small molecule drug, an exact copy of its simple structure can be created by other companies resulting in a generic version of the drug.2,4 The generic version is deemed bioequivalent to the brand name as it is created using the same, relatively simple chemical recipe. In contrast, biologic medicines are large proteins requiring many intricate steps in their production in living cells using complex biotechnology processes. As such, it is not possible to create an exact, identical copy or “generic” version of the originator biologic upon expiry of patent, therefore these medicines are termed biosimilar.
Health Canada requires biosimilar manufacturers to provide information demonstrating that the biosimilar is safe, effective, and highly similar to the reference originator biologic.4,5 Given that Health Canada is assessing the similarity of the biosimilar to the originator biologic, the type of data required to support authorization of the biosimilar is different from that of an originator biologic. The structure and function of the biosimilar are assessed, in addition to human clinical studies in patients new to biologic therapy, to confirm that there are no clinically meaningful differences in safety and efficacy between the biosimilar and originator biologic.4,5
Summary: Biologic therapies currently available in Canada for inflammatory diseases
|Disease Space||Originator Biologic and Biosimilar Treatments||# of options|
|Ankylosing Spondylitis||Humira®, Cimzia®, Enbrel, Brenzys, Erelzi, Simponi®, Remicade®, Inflectra®, Renflexis®, Cosentyx®||6|
|Crohn’s Disease||Humira®, Remicade®, Inflectra®, Renflexis®, Stelara®, Entyvio®||4|
|Juvenile Arthritis*||Orencia®, Humira®, Kineret®, Enbrel, Erelzi, ActemraTM||5|
|Pediatric Crohn’s Disease||Humira®, Remicade®, Renflexis®||2|
|Pediatric Ulcerative Colitis||Humira®, Remicade®, Renflexis®||2|
|Psoriasis||Humira®, Enbrel, Remicade®, Inflectra®, Renflexis®, Cosentyx®, Stelara®||5|
|Psoriatic Arthritis||Orencia®, Humira®, Cimzia®, Enbrel, Simponi®, Remicade®, Inflectra®, Renflexis®, Cosentyx®, Stelara®||8|
|Rheumatoid Arthritis||Orencia®, Humira®, Kineret®, Cimzia®, Enbrel, Brenzys, Erelzi, Simponi®, Remicade®, Inflectra®, Renflexis®, Rituxan®, ActemraTM, Stelara®||10|
|Ulcerative Colitis||Humira®, Simponi®, Remicade®, Inflectra®, Renflexis®, Entyvio®||4|
*Juvenile Idiopathic Arthritis/Juvenile Rheumatoid Arthritis.
You can find more information about each of these medications by searching the Health Canada Drug Product Database.
What is Health Canada saying?
Health Canada does not consider biosimilars to be identical or bioequivalent to their originator reference biologic and states that biosimilars are not the same as generic drugs.4,6 However, approved biosimilars are safe, effective, and highly similar to the reference originator biologic and there are no clinically meaningful differences in safety and efficacy between them in patients newly started on biologic therapy.
Health Canada recommends that any decision to switch a patient from an originator biologic drug to its biosimilar should be made by the physician in consultation with their patient, taking into account the clinical evidence available as well as any prescribing policies in the relevant jurisdiction.4,6
Want to learn more about biologics and biosimilars? Click here.