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Biosimilar – Definition, Approval and Use
A biosimilar is a biological medicine that is highly similar to an already approved reference biological product in terms of quality, efficacy, and safety.
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A biosimilar is a biological medicine that is highly similar to an already approved reference biological product in terms of quality, efficacy, and safety.
What Is a Biosimilar?
A biosimilar is a biological medicine developed as a follow-on product to an already approved biological reference medicine, also known as the reference biologic. Biological medicines are manufactured using living cells -- such as bacteria, yeast, or mammalian cells -- and are inherently more complex than conventional chemically synthesised drugs. A biosimilar is highly similar to its reference product in structure, efficacy, and safety, but not identical, as biological manufacturing processes always involve a degree of natural variability.
Difference Between a Biosimilar and a Generic Drug
Biosimilars are often confused with generic drugs. Generic drugs are exact chemical copies of small, synthetic molecules. Biosimilars, on the other hand, are follow-on versions of large, complex biological molecules such as monoclonal antibodies, erythropoietin, or insulin. Due to their biological complexity, biosimilars cannot be considered identical copies; instead, they must undergo extensive comparability studies to demonstrate similarity to the reference biologic.
Approval and Regulation
In the European Union, biosimilars are regulated and approved by the European Medicines Agency (EMA). The approval process is rigorous and includes:
- Physicochemical and biological comparability studies
- Preclinical (animal) studies
- Clinical trials evaluating efficacy, safety, and immunogenicity
In the United States, biosimilars are regulated by the Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act (BPCIA). Since the approval of the first biosimilar in Europe in 2006, the market has grown substantially worldwide.
Therapeutic Areas
Biosimilars are used across a wide range of medical specialties. Common therapeutic areas include:
- Oncology: Supportive treatment in cancer care (e.g., G-CSF biosimilars to stimulate white blood cell production)
- Rheumatology: Treatment of rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis (e.g., biosimilars to adalimumab or etanercept)
- Gastroenterology: Management of Crohn's disease and ulcerative colitis (e.g., infliximab biosimilars)
- Diabetology: Insulin therapy (e.g., insulin biosimilars)
- Nephrology: Treatment of renal anaemia (e.g., erythropoietin biosimilars)
Benefits of Biosimilars
Biosimilars offer significant advantages for both patients and healthcare systems:
- Cost savings: Biosimilars are generally less expensive than the reference biologic, leading to substantial savings in healthcare budgets and broadening patient access to advanced therapies.
- Comparable efficacy and safety: Because biosimilars undergo a stringent approval process, their clinical efficacy and safety profile is comparable to that of the reference biologic.
- Increased market competition: The availability of biosimilars promotes competition in the pharmaceutical market, which can help drive further innovation.
Safety and Interchangeability
A frequent topic surrounding biosimilars is interchangeability with the reference biologic. In the EU, an approved biosimilar is generally considered therapeutically equivalent to its reference product. However, any decision to switch from a reference biologic to a biosimilar -- or between biosimilars -- should always be made in consultation with the treating physician. Careful monitoring for adverse reactions is essential, particularly regarding immunogenicity (the potential of a medicine to trigger an unwanted immune response).
References
- European Medicines Agency (EMA): Guideline on similar biological medicinal products. EMA/837805/2011. Available at: https://www.ema.europa.eu
- U.S. Food and Drug Administration (FDA): Biosimilar Development, Review, and Approval. Available at: https://www.fda.gov/drugs/biosimilars
- World Health Organization (WHO): Guidelines on evaluation of similar biotherapeutic products (SBPs). Geneva: WHO Press, 2009.
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