Recent Findings Highlight Need for Policy Changes for Biosimilars, Follow-on Biologics

Recent data could contribute to discussions on generating more transparency about global approvals of follow-on biologics and supporting access to high-quality biosimilars in countries around the world, according to a study published in BioDrugs.

The study used the term follow-on biologic as an umbrella term for FDA-classified biosimilars as well as biologics that are biosimilars by definition but are not officially declared as such in the United States (eg, Basaglar, Granix). This is because they were approved before the establishment of the biosimilar approval pathway (the Biologics Price Competition and Innovation Act). These products, sometimes called authorized generics, may be classified as biosimilars in other global markets.

This study was conducted because present knowledge is limited about which manufacturers are active globally in biopharmaceutical product development and how many unique follow-on biologics are approved in international markets.

First, researchers wanted to provide a cross-sectional overview of manufacturers of follow-on biologics approved in 15 countries from different regions of the world, and in 5 major biosimilar markets with long-established biosimilar frameworks.

“The biosimilar approach involves a robust comparability exercise to prove that the follow-on biologic is clinically equivalent to the innovator product and does not compromise on safety and efficacy,” the researchers wrote.

Next, national drug databases were screened to distinguish follow-on biologics and their manufacturers approved in 15 countries in Asia, Africa, Latin America, and the rest of the globe, and 5 major biosimilar markets: the European Union (including the United Kingdom), the United States, Canada, Australia, and Japan.

Then, the study detected 304 follow-on biologics from various manufacturers for 18 active substance classes included in the analysis. Of these, 67 products were approved as biosimilars in at least 1 of the 5 major biosimilar markets. This study found that the bulk of follow-on biologics were only approved in their respective country of manufacturing. A small number of these, primarily from India and Argentina, supplied their products to other parts of the world.

“As some countries have less stringent regulatory approaches for biosimilars, or have only recently implemented biosimilar guidance in line with World Health Organization (WHO) standards, follow-on biologics could have been approved that would not be considered biosimilars according to the [WHO] standards,” said the researchers.

Researchers expect that a significant portion of the 237 follow-on biologics, particularly recent approvals, can be considered biosimilars according to WHO biosimilar standards despite not being available as biosimilars in any of the 5 major biosimilar markets.

The authors made a number of takeaways and policy recommendations based on the results, including:

• More globally concerted efforts are needed to improve transparency about manufacturing and approvals of follow-on biologics.
• The lack of global understanding of follow-on biologics could have severe implications for various stakeholders, including patients.
• Several implications from a national perspective were highlighted, especially regarding clinical practice and pharmacovigilance.
• The use of different brand names in different countries could create challenges for the identifiability of follow-on biologics, especially for drug safety monitoring.
• Using identical international nonproprietary names for biosimilars and noninnovator biologics (ie, follow-on biologics that cannot be considered biosimilars according to the WHO) could create switching challenges for clinical practice, especially if the products coexist in the same market.
• The WHO holds an important role as a neutral and global institution to collect and provide information on approvals of all follow-on biologics found in the global market.
• Advocacy for greater regulatory reliance to facilitate faster and broader access to high-quality biosimilars worldwide could help speed up access in low- and middle-income countries.

Based on the findings of this study, the researchers recommend follow-up studies to analyze the possible existence of noninnovator biologics in global markets.

“In the end, this study wants to contribute to discussions on how to improve and accelerate global access to safe and high-quality biosimilars that are imperative for healthcare systems around the world,” the researchers concluded.

This study only provides a glimpse of approvals of follow-on biologics. The information provided is dependent on the completeness of information databases and other regulatory documents, and the available information on initial approval dates of individual follow-on biologics was limited, which could all be considered limitations.

Reference

Klein K, Gencoglu M, Heisterberg J, Acha V, Stolk P. The global landscape of manufacturers of follow-on biologics: an overview of five major biosimilar markets and 15 countries. BioDrugs. 2022;37:235-245. doi:10.1007/s40259-022-00568-0