Biosimilars vs. Biologics: Breaking Down the Similarities and Differences

Biosimilars vs. Biologics: Breaking Down the Similarities and Differences


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  • Source: Microbioz India

  • Date: 14 Oct,2023

Although both biologics and biosimilars are significant drug classes utilized in healthcare, they differ in terms of their properties, approval processes, and price points.

Here’s a breakdown of their similarities and differences:


  1. Origin: Complex medications known as biologics are derived from living things like bacteria, yeast, or mammalian cells. They consist of medicinal proteins, vaccinations, and monoclonal antibodies.
  2. Production: The creation of biologics is a difficult and drawn-out process that involves living cells and frequently necessitates the use of specialized facilities.
  3. Patent Protection: Compared to small-molecule medications, biologics often have longer patent protection periods, which can lead to exorbitant costs and little market competition.
  4. Regulation: Biologics must pass rigorous regulatory approval procedures, including clinical studies, carried out by regulatory agencies like the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA).
  5. Interchangeability: Due to the intricacy of these medications, there is no such thing as a “generic biologic” in contrast to generic medications. The use of biosimilars is proposed as a substitute.


  1. Origin: Though they are very similar to biologics, biosimilars are not exact replicas. They were created with similar safety and effectiveness in mind.
  2. Manufacturing: Producing a biosimilar requires deriving a product that is similar to the reference biologic through reverse engineering. It must have the same structure and functionality as the reference product.
  3. Patent Protection: Biosimilars are released after the reference biologic’s patent protection has run out, allowing for more competition and perhaps reduced prices.
  4. Regulation: Although the regulatory approval process for biosimilars is rigorous, it is not as thorough as the procedure for the original biologic. The objective is to show that in terms of potency, purity, and safety, the biosimilar is very similar to the reference product.
  5. Interchangeability: Some biosimilars might be regarded as interchangeable with the reference biologic, which would allow users to swap them out for the original medication without visiting a doctor. Regulation-related choices may cause this to change or not always be the case.

Similarities: Biosimilars vs. Biologics

  1. Therapeutic Uses: Both biologics and biosimilars are used to treat a variety of illnesses, such as chronic disorders, autoimmune diseases, and cancer.
  2. Safety and Efficacy: To receive regulatory approval, both biologics and biosimilars must adhere to strict safety and efficacy requirements.

Differences: Biosimilars vs. Biologics

  1. Complexity: Compared to biosimilars, biologics frequently have more intricate structures and functions.
  2. Cost: Because biosimilars are frequently less expensive than biologics, patients may find them to be more readily available.
  3. Regulatory approach: Biosimilars do not need to repeat all the clinical trials necessary for the reference biologic, hence their regulatory approach differs from that of biologics.
  4. Interchangeability: This idea does not apply to biologics, while some biosimilars are designated as interchangeable.

In conclusion, biosimilars are created as extremely similar replacements that are presented after the patent protection of the reference biologic has expired. Biologics, on the other hand, are the original, complicated drugs derived from living creatures and go through significant regulatory processes. Biosimilars offer market competition, potentially driving down prices and expanding access to these crucial treatments. Nevertheless, the procedure for regulatory approval guarantees that biosimilars are secure and efficient for patient usage.

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