'Biosimilar approval pathways: comparing the roles of five medicines regulators' by Ryan P Knox, Vineet Desai and Ameet Sarpatwari in (2024) 11(2) Journal of Law and the Biosciences comments
Biologics are playing an increasingly important role in health care globally but are placing a substantial burden on payers. The development of biosimilars—drugs that are highly similar to and have no clinically meaningful differences from originator biologics—is critical to improving the affordability and accessibility of these medications. Medicines regulators, however, have had varied success with biosimilars to date. We examined agency guidance documents, peer-reviewed articles, and gray literature related to biosimilars in Australia, Canada, the European Union, the United Kingdom, and the United States to evaluate variations in the approaches to biosimilar approval taken by their respective medicines regulators. We found that the medicines regulators take similar approaches to biosimilar approvals, but that differences in their policies and their jurisdiction’s laws regarding testing requirements, indication extrapolation, exclusivities, and substitution may contribute to the varied successes of biosimilars observed. Policies supportive of product-specific guidance, extrapolation, shorter exclusivity periods, and substitution were correlated with greater success in biosimilar approval and uptake. As medicines regulators work to promote biosimilars, understanding the impact of these laws and policies is crucial. Reforms consistent with these policies can create regulatory environments more supportive of biosimilar approvals, promoting access to affordable biologics for patients globally.
Biologic drugs are complex biopharmaceuticals manufactured from living organisms or derived from their cells and tissues. They are playing an increasingly important role in medical treatments, revolutionizing care for patients with various cancers, autoimmune conditions, and genetic disorders. At the same time, biologics are taking up a larger share of health care spending. Although biologics—such as high-profile blockbuster medications including Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab) —comprised only 0.4% of drugs prescribed in the United States (US) in 2018 and only 2% of prescription drug claims in Canada in 2021, they represented 46% of net drug spending and 29% of public drug spending in those countries in those years, respectively. Biologics also account for a similarly high percent of prescription drug spending in Australia, the European Union (EU), and the United Kingdom (UK). This disproportionate spending is due to the high prices of biologics. For example, the list price for the blockbuster immunotherapy Keytruda (pembrolizumab) in 2021 was ~$175,000 per patient per year in the US. By 2022, at least three biologics had US list prices greater than $1 million per patient per year.
To address the high cost of biologics, governments in several countries have developed specialized pathways for medicines regulators to approve highly similar follow-on biologics that have no clinically meaningful differences from an ‘originator’ (or reference) biologic. These ‘biosimilars’ are intended to promote competition, thereby lowering the price of treatment for patients and health systems ...
To date, the number of biosimilars that have been approved by medicines regulators has varied widely (Table 1). As of May 31, 2024, the US Food and Drug Administration (FDA) had approved 53 biosimilars, the European Medicines Agency (EMA) 101, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 93, Health Canada 58, and Australia’s Therapeutic Goods Administration (TGA) 55. Although EMA has been approving biosimilars longer than the other regulators—since 2006—only in the last 5 years have other regulators had similar approval rates