Flexibility and education keys to overcoming biosimilar barriers


Head of Biopharma Excellence and Chief Medical Officer for Strategic Product Development Consulting, PharmaLex


Since the first biosimilar approval nearly 20 years ago, these lifesaving products have steadily gained an important foothold in U.S. and European markets. These near copies of approved biologic products hold the potential to increase patient access, promising treatments for cancer, autoimmune or inflammatory conditions.


While early biosimilars had limited adoption and financial savings, biosimilars launched in recent years have achieved significant uptake and savings thanks to their increased acceptance by healthcare stakeholders and new market opportunities. Yet, while analysts predict that the market could triple in value (1), barriers remain, particularly related to testing requirements.


A panel of industry experts share their insights on where the biosimilar industry is headed and how health authorities can support and influence efficient biosimilar development methods. With more biologics set to lose exclusivity, more competition from biosimilars could lead to a greater number of life-changing treatments at a lower cost, benefiting patients and healthcare systems. To achieve this, the panelists agree that what is needed is more industry-regulator collaboration, particularly with regards to updating and aligning the guidance to create more efficiencies.


The article explores:

  • Regulatory pathways and how these might impact biosimilar progress
  • The use of comparative analytics in the development of biosimilars, including PK/PD studies to analyze variability
  • The importance of educating stakeholders on the science behind biosimilars
  • Advances in PD markers in demonstrating biosimilarity and ongoing research into new, more sensitive PD markers

As demand for biosimilars grows, so does the imperative to address barriers to their development. Christian Schneider reports from a recent panel discussion with industry experts he moderated.


With a record number of biosimilars set to be released in the US and European markets in the coming years, the worldwide market is forecast to reach $74 billion by 2030 (2).


The first biosimilar was approved in Europe in 2006 and, while uptake and savings did not initially meet expectations, manufacturing and testing of biosimilars has improved over time. What seemed impossible in the past – for example, biosimilar monoclonal antibodies – is now considered fairly mainstream.

After a slow initial uptake, there is growing recognition of the potential for biosimilars to offer a more affordable alternative to expensive biologic therapies, increasing patient access to life-changing therapies.


In the US alone, it is estimated that biosimilars have saved the healthcare system about $23.6 billion since the Food and Drug Administration (FDA) approved the first biosimilar in 2015 (3).


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