Watch the video below to establish an understanding of biosimilar medications, the differences between biosimilars and generic drugs, and how biosimilars are named.
Biosimilar Development
Europe is leading the way in terms of biosimilar development. The first biosimilar was approved in Europe in 2006, and the first biosimilar was not approved in the United States until 2014. There are nearly double the amount of biosimilars approved and on the market in Europe compared to the United States.
One of the barriers in the United States affecting biosimilar approval is drug patent laws. There have been many costly patent litigations that have taken place over biosimilar implementation. Another barrier that has delayed utilization of biosimilars is the lack of education among providers and patients about biosimilars.
Development Timeline & Cost
For a new biologic drug, the research and development process usually takes over ten years to complete, and the price tag associated with it is close to $3 billion. The costly and lengthy approval process for biosimilars initially hindered biosimilar development. That was until 2009 when Congress signed the Biologics Price Competition and Innovation Act as a part of the Affordable Care Act.
The goal of this Act was to create competition, reduce the cost, and increase patient access to biosimilar medications. This new abbreviated pathway allowed the timeline of biosimilar development to be reduced to 5 to 9 years and the cost decreased to approximately 100 million. A similar process was implemented for generic medication in 1984.
Biosimilar Approval Process
Watch the following video to learn about the biosimilar FDA approval process and interchangeability.
Interchangeability Governance
The video explains how a biosimilar can achieve interchangeability, meaning that an originator biologic medication can be switched to a biosimilar without additional approval from the provider. Interchangeability is governed by your individual state. It’s important to know your state laws on interchangeability. You can look up your state laws for biosimilarity interchangeability on the CardinalHealth website [External link].
Biosimilar Provider FAQ
Click the each drop down to read the answers. You can also download the FAQs using the link below the box.
What is a biosimilar? (click to reveal)
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A biosimilar is a biologic medication that is made from proteins, cells, and tissues that target the immune system. The term “biosimilar” means that the medication is highly similar to the brand name biologic (aka “originator”).
Is a biosimilar the same as a generic drug? (click to reveal)
- No. Generic drugs are manufactured by a chemical process and so they are completely identical to brand name drugs. However, since biologics and biosimilars are made from living proteins, it is impossible to make them identical to each other. Nonetheless, biosimilars are considered to be bio-therapeutic products that are similar in terms of quality, safety, and efficacy to the reference product.
Does the originator work better than the biosimilar? (click to reveal)
- No, studies have shown that there is no difference in efficacy of a biosimilar compared to the originator product. There is also no difference in antibody development between the biosimilar and originator product.
Is there a difference in the side effects between the originator and a biosimilar? (click to reveal)
- No, studies have shown there is no difference in side effects between the originator and the biosimilar because they are highly similar medications.
Have biosimilars been used before? (click to reveal)
- Yes, biosimilars have been used in Europe since the early 2000s, and finally received approval in the United States. Many other biosimilars are expected to be coming to the market in the next several years.
How is a biosimilar dosed and administered? (click to reveal)
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Biosimilars have the same mechanism of action, route of administration, dosage form, and strength as the reference product.
Is there a different order to check a biosimilar drug level and antibodies? (click to reveal)
- No, the order to check a level or antibodies is exactly the same as the originator. This highlights how similar these two medications are.
Why are we suddenly using biosimilars instead of the brand name biologics? (click to reveal)
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Biosimilars are now the preferred product on many insurance plans. Biosimilars are expected to be 15-50% less expensive than brand name biologics and have the potential to dramatically decrease healthcare dollars spent on biologic therapy.
Biosimilar Patient Resources
Download the infographic below to share with patients who wish to learn more about biosimilars.