Biosimilars | Aplastic Anemia and MDS International Foundation (AAMDSIF) Return to top.


Introductory image: Manny with Girl at Conference

What is a Biosimilar?

A biosimilar is a type of biologic medication. The term “biosimilar” means that the medication is highly similar to the already approved brand name biologic (“originator” medication). Biosimilars are not generic versions of the original biologic.

Difference Between Generic Drugs and Biosimilars

Generic drugs have identical active ingredients to brand name drugs and are made from synthesized chemicals. Biosimilars are highly similar to the brand name drugs and are made from living organisms. Approved generic drugs are automatically deemed interchangeable with brand named medications since they have the same active ingredients. Biosimilars are not automatically interchangeable without an additional approval process.

How Is a Biosimilar Approved?

Like brand name drugs, biosimilars go through a rigorous approval process. To gain approval, a biosimilar must demonstrate, based on data, that it is highly similar to the already approved brand name biologic. It must demonstrate no clinically meaningful differences in safety, purity, and potency from the brand name product. A manufacturer must provide data comparing the biosimilar to the approved brand name biologic to demonstrate biosimilarity. The data required for approval can come from different sources including but not limited to analytic studies (comparison of products), pre-clinical studies, and clinical studies/trials.

What is an Interchangeable Biosimilar?

An interchangeable biosimilar is a biosimilar that meets additional requirements for approval. These products can be substituted for the original product without consulting the prescriber, just like generic drugs are substituted for brand name drugs. This is called pharmacy -level substitution and is subject to state pharmacy laws.

Are Biosimilars Safe?

Like brand name drugs, biosimilars go through a strict process for approval before being available to patients to evaluate the safety and use. Data must show it is safe for use in people and as effective as the approved brand name drug. If a biosimilar has received approval, this means it has met strict standards for being safe.

Questions to Ask Your Physician:

  1. Is a biosimilar a treatment option for me?
  2. Is it safe for me to switch from a biologic to a biosimilar?
  3. What is involved with me switching from a biologic to a biosimilar?
  4. What are the benefits and risks of switching to a biosimilar?
  5. How is the biosimilar given?
  6. What is the dosing schedule?
  7. What should I expect once I start treatment? Side effects?
  8. When should I see a response to treatment?
  9. What happens if I miss a dose?
  10. Will my insurance cover the biosimilar treatment? What will be the cost to me?
  11. How will we monitor the effectiveness of the biosimilar treatment?
  12. If the biosimilar treatment does not work for me, can I restart the biologic treatment?
  13. Are you treating other patients with the same biosimilar treatment and what has been their response?
  14. Where can I find educational information about the treatment?

Other Information:

This webinar will be useful to your understanding of Biosimilars: Biosimilars - Treatment Options for Patients

Find the Fact Sheet about Biosimilars and other patient information on this page: Patient Guides and Fact Sheets

AAMDSIF does not recommend, endorse, or make any representation about the efficacy, appropriateness or suitability of any drug, treatment or therapy listed on this website. Some therapies listed on our site are considered experimental for the treatment of bone marrow failure diseases. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding any therapy, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.