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2024/11/25 Streamlining Development Process is Key to Biosimilar Access – Part 2


In the 
first part of the blog, Joseph Park, Senior Manager of Regulatory Affairs Team/Regulatory Strategy and Policy, discussed improving efficiency of biosimilar development by reducing unnecessary comparative clinical efficacy studies. For biosimilars, quality data derived from analytical and functional testing and pharmacokinetics data which may also generate immunogenicity data are sufficiently robust and convincing for regulatory decision making. Comparative clinical efficacy studies use traditional effectiveness and/or pharmacodynamic endpoints that are substantially less sensitive to detect clinically meaningful differences between a biosimilar and the reference product than the analytical and functional studies already in standard use. Comparative clinical efficacy studies, with redundant regional requirements, only hinder timely access to biologics. In this second part of the blog, Joseph discusses acknowledging “global reference products” which would enable sponsors to prepare a single data package globally, acceptable in all jurisdictions.

 

When the reference product is global so should it be possible for there to be a globally-available biosimilar

 

Regulatory efficiency can be further achieved through acknowledging that when the reference product is global so should it be possible for there to be a globally-available biosimilar. This is variously called the global reference product or global comparator product, and its acknowledgement avoids scientifically unnecessary studies to bridge the non-local and local reference products. Studies shouldn't have to be repeated using locally-sourced reference material if the reference product is known to be the same across jurisdictions, as, for example, is evidenced from the approval in each jurisdiction being based on the same pivotal clinical studies with the evidence supporting this publicly available. The duplication of bridging studies is an unnecessary barrier to biosimilar development as it contributes to high development costs and consequently delays patient access to biosimilars.

 

Regulatory authorities can immediately implement policies that support waiving bridging studies between a local reference product and a non-local reference product, when provided with such documentation, in order to decrease the time and expense required to develop and manufacture biosimilar medicines. This can improve patient access to biosimilar medicines globally similarly quickly.

 

The good news is that the acceptance of streamlined biosimilar development by the global regulators looks increasingly likely, for example as seen in the International Pharmaceutical Regulators Programme (IPRP) Biosimilar Working Group (BWG) Workshop that took place in September 2023, and the subsequent summary report issued in July 2024. At this workshop, there was a general convergence among regulators and industry experts alike around re-examining the need for CES, given their not being sensitive enough to detect anything beyond very large analytical differences between a proposed biosimilar and its reference product. Similarly, the regulators agreed that such CES are not likely to be informative with respect to the small differences typically observed in analytical comparisons, particularly if comparative PK show well-matched profiles between a proposed biosimilar and its reference product. The IPRP summary report acknowledges that CES should be used only if designed purposefully to answer a specific question that cannot be addressed from the comparative functional characterization. While the regulators also recognized the current challenges that must be addressed to advance streamlined development further, including uncertainty around the extent of data required to obtain the CES waiver and when it can be assured, the regulators are definitely moving in this scientifically-appropriate direction.

 

Streamlining biosimilar development – elimination/reduction in CES and acknowledgment of global reference products – will not have the impact on global patient access unless it is adopted by the leading regulatory authorities.

 

Coordinated studies that provide data upon which regulatory decisions can be taken in multiple jurisdictions concurrently are efficient for all stakeholders and create predictability for sponsors. Thus, enabling biosimilar sponsors to prepare a single data package globally, acceptable in all jurisdictions, would support more timely and equitable access to affordable therapies.

 

Webster C., Woollett, G. A ‘Global Reference’ Comparator for Biosimilar Development. May 2017.  http://link.springer.com/article/10.1007%2Fs40259-017-0227-4

International Pharmaceutical Regulators Programme (IPRP). Workshop Summary Report: Increasing the Efficiency of Biosimilar Development Programs — Reevaluating the Need for Comparative Clinical Efficacy Studies. 2024. https://admin.iprp.global/sites/default/files/2024-07/IPRP_BWG_Final%20IPRP%20Scientific%20Workshop%20Summary%20Report_2024_0506.pdf

Already an obligation under the Declaration of Helsinki  https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/


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