Biologics and Biosimilars

Derived from living organisms, biologics (including biosimilars) are protein-based medicinal products that treat a variety of complex diseases and medical conditions.1-2

  • Rheumatoid arthritis
  • Anemia
  • Inflammatory bowel disease
  • Diabetes
  • Psoriasis
  • Cancer
  • Hormone deficiency

BIOLOGICS ARE COMPLEX, WITH DISTINCT DIFFERENCES COMPARED TO SMALL MOLECULES

Unlike small molecules, which are a medication usually chemically synthesized, biologics are typically large and more complex.2

  SMALL MOLECULE DRUGS   BIOLOGIC MEDICINES
MOLECULAR SIZE, STRUCTURE & COMPOSITION

Small molecule2

Small molecule2

MOLECULAR SIZE, STRUCTURE & COMPOSITION
Manufacturing Chemically synthesized Manufacturing Due to the size, complexity and natural variability of biologic drugs, and because biologic drugs are made in living cells rather than with chemicals, a biosimilar and its reference biologic drug can be shown to be similar, but not identical.
  • What Are Biosimilars?

     

    A biosimilar is a biologic drug that enters the market after the originator biologic and with a demonstrated similarity to the originator biologic.2

    Biologic drugs are generally larger and more complex than chemically produced pharmaceutical drugs and are made from living cells.1

    Biosimilars are not generics

    Generic drugs are small molecules that are chemically synthesized and contain the same active ingredient to their brand name reference products.2

    The generic manufacturer must provide studies showing that the different non-medicinal ingredients have not changed the quality, safety or effectiveness of the generic drug.6 The studies that compare the generic drug with the brand name drug are called “comparative bioavailability” studies. In these studies, the level of a medicinal ingredient in the blood of healthy human volunteers is measured. Some drugs, like those injected directly into the blood stream, do not need comparative bioavailability testing.

    BIOSIMILARS ARE DIFFERENT

    Due to the size, complexity and natural variability of biologic drugs, and because biologic drugs are made in living cells rather than with chemicals, a biosimilar and its reference biologic drug can be shown to be similar, but not identical.2

    Similarity is demonstrated using a step-wise approach that begins with initial structural and functional studies.2 This testing is followed by human clinical studies. All the information from these studies is used to confirm that the biosimilar and originator biologic are similar, and there are no clinically meaningful differences in safety and efficacy between them.2

Glossary:

Bioavailability: the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect.7

Dalton: a unit used in expressing the molecular weight of proteins, equivalent to atomic mass unit.8

Pharmacodynamics (PD): a branch of pharmacology dealing with the reactions between drugs and living systems.9

Pharmacokinetics (PK): the branch of pharmacology concerned with the movement of drugs within the body.10

References:

1. Health Canada. Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Revised November 14, 2016. Available online: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2016-eng.pdf (Accessed December 2016). 2. Health Canada. Drugs and Health Products. Fact Sheet: Biosimilars. Available at: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/biosimilars-biosimilaires-qa-qr-eng.php. Accessed on Feb 6, 2017 3. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBP’s). Expert Committee on Biological Standardization. Geneva, 19-23 October, 2009. 4. National Center for Biotechnology Information. Aspirin. http://pubchem.ncbi.nlm.nih.gov/compound/aspirin#section=2D-Structure Accessed December 9, 2015. 5. Remicade Product Monograph. Janssen Inc. April 26, 2016. Genazzani AA, Biggio G, Caputi AP, et al. Biosimilar drugs. Concerns and opportunities. Biodrugs. 2007;21(6):351–356. CURRENT OPINION. 6. Health Canada. The Safety and Effectiveness of Generic Drugs. Available at: https://www.canada.ca/en/health-canada/services/healthy-living/your-health/medical-information/safety-effectiveness-generic-drugs.html 7. English Oxford Living Dictionaries. Available at: https://en.oxforddictionaries.com/definition/bioavailability Accessed July 19, 2017. 8. English Oxford Living Dictionaries. Available at: https://en.oxforddictionaries.com/definition/dalton Accessed July 19, 2017. 9. Webster Medical Dictionary. Medline Plus. Available at: http://c.merriam-webster.com/medlineplus/pharmacodynamics Accessed July 16, 2017. 10. English Oxford Living Dictionaries. Available at: https://en.oxforddictionaries.com/definition/pharmacokinetics Accessed July 19, 2017.

Learn more about demonstrating biosimilarity
More Information