Biologic v. Biosimilar: how does a biosimilar measure up?

biologic and biosimilar comparison chart

You may have heard of biologics and biosimilars but may be wondering about their similarities and differences, and what they mean for treatments. While they each provide treatment options for a variety of conditions like arthritis and cancer, these products aren’t carbon copies of each other in every sense. Biologics revolutionized the industry, but biosimilars are assisting in advancing these therapies to improve accessibility to lifesaving treatments.

What’s The Difference?

Although safety and efficacy are at the top of mind for both products, there are a few key differences that distinguish the two:

  • Regulatory Path - The approval process for biosimilars is more streamlined than biologics. This doesn’t make them any less safe, it only reinforces the clinical equivalence.

  • Cost - Biosimilars may be less expensive, increasing treatment options. With a more streamlined developmental path, biosimilars become cost-effective over their biologic counterparts.

  • Development Timeline - Biosimilars take around 8-10 years to develop due to advanced technology and through evidentiary support of the biologic reference product whereas biologic development can take up to 15 years.

What’s The Same?

  • Clinical Trials - Biologics and biosimilars both require rigorous clinical trial testing.

  • Produced With A Living System - Both are made from living sources such as plant or animal cells.

  • Treatment - The two products offer the same treatment outcomes, possible side effects, and are administered the same way.

The Future of Biosimilars

With the current documented successes of biosimilars and the expensive demand for biologics, the biosimilars market is poised to expand globally, helping companies accelerate time to market while improving productivity. As regulatory environments evolve across the world, coupled with “blockbuster” molecules set to lose exclusivity, the opportunity for uninterrupted market entry for biosimilars continues to rise. The global biosimilar market is projected to surge from an already high $25.1 billion in 2022 to $1.3 trillion by 2032, boasting a 17.6% growth rate.[1] Collectively driven by heightened disease prevalence, rising demand, and a cost-effective nature for patients and healthcare providers alike, biosimilars will become more of a household term.

This exponential financial growth of the market opens up a huge opportunity for the future of biosimilar research & development through analytical studies, market research, indication development, clinical trial studies, and name development.

To learn more about our pharmaceutical asset development services, visit our services page. To speak with one of our pharmaceutical branding experts, contact us.

  1. https://www.centerforbiosimilars.com/view/global-biosimilar-market-projected-to-reach-1-3-trillion-by-2032

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