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Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility


Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.

Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece published in BioDrugs.

Patients can still struggle with accessing biological therapies in some markets. There is a need to streamline the biosimilar development process without compromising quality, safety, or efficacy.

This piece—written by 4 prominent voices in the biosimilars space from different pharmaceutical companies—weighs the efficiencies that could be attained within the biosimilar approval process.

Biosimilars have been on the market in the United States since 2015, and Europe since 2005. In that time, biosimilars have become established in the treatment landscape for a wide range of disease, enabling patient access and health care affordability.

The authors recommended multiple changes to streamline biosimilar development straightaway without compromising patient safety or product quality, such as:

  • Limiting clinical studies to comparative pharmacokinetics (PK)
  • Using a risk-based approach when evaluating immunogenicity
  • Eliminating bridging PK studies through acceptance of global comparator reference product
  • Immediately reconsidering the requirement for multiple-switch studies to obtain US interchangeability designations, and future removal of that category

Updating biosimilar guidelines to reflect more streamlined biosimilar development will create more regulatory certainty and help ensure a sustainable future market for biosimilars that will allow funding in health care budgets for newer medications.

“The proposed steps will expand worldwide access to these increasingly essential medicines in a manner that does not compromise the quality, safety, and efficacy of biologics for any patients, whatever jurisdiction in which they happen to reside,” explained the authors.

The authors noted an IQVIA report that found that about half of biologic drugs coming off patent in the next decade may have no biosimilar competitors, partially because the market size is too small to warrant the exhorbidant costs and time associated with biosimilar development and clinical trials. Biosimilars can cost as much as $300 million and take up to 9 years to develop.

Additionally, the authors noted that the current regulaotry paradigm is reflective of the time in which it was created, when there was more skepticism around the creation of biosimilars in relation to their reference products. However, new experience and 2 decades worth of data call into question whether the same analyses required in 2005 are needed to prove that a biosimilar has no clinically meaningful differences to the reference product today.

"The potential for increased or different immunogenicity was one of the foremost concerns when the biosimilar development pathway was first developed.... While immunogenicity data should always be collected for both biosimilars and novel biologics, to date, the immunogenicity levels elicited by biosimilars approved by the FDA and European Medicines Agency have reliably matched the immunogenicity of their reference products. This evidence allows the conclusion that potential immunogenicity issues are less of a concern than initially conjectured."

Despite the availability of increased biosimilar access and lowering health care costs, many patients who could benefit from biologics struggle to get opportune and inexpensive access, especially in areas like the United States and lower- and middle-income countries, where access is even more limited.

Immunogenicity evidence allows the conclusion that possible immunogenicity problems are less of a concern than first thought. There are opportunities to revise the present biosimilar development paradigm to increase the efficiency of future biosimilar development by applying current science and already obtained experience with the development and marketing of biosimilars to date.

Ultimately, the authors suggest that immunogenicity analysis biosimilars be moved to a risk-based consideration as opposed to a global and routine necessity.

Comparative efficacy studies lack validity because no human clinical studies should be conducted unless meaningful new information can be gained, and this experience can be adapted into revised regulatory practice.

In general, experience to date suggests that a more targeted approach to the inclusion of clinical efficacy studies in biosimilar approval applications is needed. Certainly, regulators with extensive biosimilar experience have suggested reducing some routine requirements for comparative clinical efficacy studies.

The authors emphasized that, given the collective experience of all stakeholders, it’s time to reconsider the routine expectation for a comparative efficacy study when developing a biosimilar. Conducting additional and unnecessary clinical studies suspends biosimilar development and increases development costs, both will inevitably have a negative impact on access. Separating studies for regulatory decision-making purposes from those for stakeholder education is vital.

They also recommend that for optimal pharmacovigilance, it is vital to pinpoint not just the brand name or the nonproprietary name, but also the batch number. Growing the quality of pharmacovigilance is important for all drugs and in all regions to facilitate safety assessment after introduction into the marketplace.

It is unlikely that real-world evidence will replace detailed analytical comparisons or PK clinical studies when developing a preapproval data package to support licensure of a biosimilar. However, as the use of real-world evidence grows in regulatory decision-making actions for originator biologic approvals, its value for biosimilars may be important to also consider.

"The opportunity to streamline biosimilar development has been recognized by multiple stakeholders. Concurrently, demands for access to biologics at more affordable prices are likely to increase in all regions, both developed and emerging. Viable competition in all regions can only occur and be sustainable if biosimilars can be developed and manufactured more efficiently."


Cohen HP, Turner M., McCabe D, Woollett GR. Future evolution of biosimilar development by application of current science and available evidence: the developer’s perspective. BioDrugs. Published online August 5, 2023. doi:10.1007/s40259-023-00619-0

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