According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.
The International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar associations, has released a new reflection paper on strengthening the regulatory system for biosimilars.
According to IGBA’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust. Stakeholders must take a number of steps in order to form a successful regulatory system for these products, including the following:
Ensure that regulatory systems approach biosimilar evaluation and approval in concert with the World Health Organization’s Similar Biotherapeutic Product guideline. Approaches should comply with a totality-of-the-evidence method to ensure adequate comparison of the biosimilar and its reference.
Recognize a global comparator product. In many cases, only 1 comparator for a given biologic is approved and uses the same data worldwide. Recognizing a global comparator would allow for the waiver of unnecessary and therefore unethical bridging studies. Biosimilar developers can establish that their local reference and foreign references are the same using publicly available information, says IGBA, and regulators have additional, nonpublic information at their disposal to confirm this fact.
Recognize that clinical trials are confirmatory in nature. Regulators should support the extrapolation of indications—which is an established scientific principle—and recognize that confirmatory trials are not needed for all indications. Furthermore, no regulators should impose localized clinical trial requirements.
Hold all biologics to the same quality standards. All biologics, including biosimilars, should meet the same regulatory standards, says IGBA.
Commit to transparency. Regulators should publish assessment reports following a harmonized template developed by the International Pharmaceutical Regulators Programme, and new regulation should be subject to a transparent and consultative process.
Identify biosimilars through unique brand names and share International Nonproprietary Names. No product-specific suffixes should be applied to biologics’ or biosimilars’ names, as there is no evidence that doing so provides greater assurance of patient safety or public health.
Ensure that biosimilar labeling mirrors the reference product’s labeling. Additional data on biosimilars is not useful in a biosimilar label, says IGBA, as the purpose of data generated for a biosimilar’s regulatory application is to confirm biosimilarity, not to provide new data for stakeholders.
Recognize that “authorized biologics” can undermine biosimilars. Authorized biologics, or alternative versions of already authorized biologics that are issued by the same company, are allowed in some regulatory territories. IGBA says this practice can hinder biosimilar competition and must be discouraged.
Acknowledge that switching among the reference product, a biosimilar, or other biosimilars of the same reference is safe under medical supervision. Only patients who are responding to treatment and who are medically stable should be switched, however.
Educate stakeholders. Ideally, education will be accomplished through multistakeholder initiatives that promote engagement and buy-in from a variety of groups. IGBA points to the European Medicines Agency and European Commission’s collaboratively designed educational materials and the Australian Department of Health’s initiative on biosimilar education as good examples of educational efforts.
IGBA’s recommendations stand in notable contrast to the FDA’s approach to several areas of biosimilar regulation; the US agency recently issued an updated draft guidance document on the naming of biologics, biosimilars, and interchangeable biosimilars that holds that meaningless, 4-letter suffixes must be applied to the names of all newly approved biosimilars and biologics, but not to the names of already approved products or transition products.
The agency also continues to require bridging studies in biosimilar development, although in 2018, the then FDA Commissioner, Scott Gottlieb, MD, said that the FDA was exploring whether it was feasible to do away with bridging study requirements.
Additionally, the US has allowed at least 1 drug maker to produce an authorized biologic; in March 2019, Eli Lilly launched a lower-priced authorized generic of its insulin lispro injection, Humalog. While insulins are currently regulated as drugs in the United States, these products and others (such as hormones) will be transitioned to regulation as biologics in 2020.