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2024/11/11 Streamlining Development Process is Key to Biosimilar Access - Part 1

Today, far too many patients lack timely access to biologic medicines. For progressive diseases, this means great pain and disability often go untreated, which occurs even in well-resourced markets like the United States (US) and Europe. Developing biosimilars efficiently can change so many people’s lives by ensuring patients have wider access to biologicals. The first part of the blog discusses streamlining biosimilar development by reconsidering regulatory requirements for comparative clinical efficacy studies.

 

47% (or $86Bn) of the currently available biologics that are facing loss of exclusivity (LOE) within 10 years have no biosimilars in development, with these molecules varying in protection status.

The future of the biosimilar market would greatly depend on improving the efficiency of development (reducing both cost and time) and there is the science to support this but reducing regulatory burdens are tough. Regulatory certainty is essential – both streamlining through reducing unnecessary clinical studies and global comparator product, if the reference is global then a biosimilar to it should be too.

The first step starts with re-examining the current regulatory requirements, by evaluating whether there are areas to improve efficiency by streamlining biosimilar development in each jurisdiction, and by sharing the results across multiple jurisdictions such as by using the revised World Health Organization (WHO) Guidelines. It is important that progress in the scientific understanding of biosimilars are reflected in the regulatory demands made of sponsors in a timely and consistent manner. This is especially crucial at the current time when we are facing a biosimilar void, with nearly half of biologics having no biosimilars in development.

 

Quality (analytical and functional testing) and pharmacokinetics (PK) data (which may also generate immunogenicity data) are sufficiently robust and convincing for regulatory decision making.

Regulators are actively reconsidering whether comparative clinical efficacy studies (CES) are necessary, i.e. whether comparative clinical efficacy studies provide additional information necessary for regulators to make decisions on biosimilar approvals. These studies use traditional effectiveness and/or pharmacodynamic (PD) endpoints that are substantially less sensitive to detect clinically meaningful differences between a prospective 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 recent reports by the European Medicines Agency (EMA) analyzing the quality and clinical data packages submitted by biosimilar sponsors, the limitation of clinical efficacy studies has been confirmed1,2. During the EMA approval procedure, biosimilar applicants need to demonstrate that the identified variations detected analytically do not affect the biosimilar's clinical performance. In practice, most of the observed differences found between a biosimilar and its reference product were resolved with either quality data alone or with a combination of quality, PK, and immunogenicity data. In no instance were data from the clinical efficacy, safety, and immunogenicity study helpful in explaining differences at the quality level. The authors of these papers concluded that the quality (analytical and functional testing) and PK data (which may also generate immunogenicity data) are sufficiently robust and convincing for regulatory decision making.
 

Confidence in the quality, safety, and efficacy of a proposed biosimilar can be attained without comparative clinical efficacy studies. Given the advancements in analytical and functional testing over the past ten years and the knowledge acquired in the development and evaluation of multiple biological molecules, the case becomes ever more compelling.

 

The next part of the blog will discuss acknowledgement of “global reference products” or “global comparator products” which enables sponsors to prepare a single data package globally, acceptable in all jurisdictions, supporting more timely and equitable access to affordable therapies.

 

 

1 Guillen E, Ekman N, Barry S, Weise M, Wolff-Holz E. A Data Driven Approach to Support Tailored Clinical Programs for Biosimilar Monoclonal Antibodies. Clin Pharmacol Ther. 113(1):108-123. (2023) https://doi.org/10.1002/cpt.2785

2 Kirsch-Stefan, N., Guillen, E., Ekman, N. et al. Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?. BioDrugs 37, 855–871 (2023). https://doi.org/10.1007/s40259-023-00631-4


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