This month the FDA updated its guidance for Labeling for Biosimilar and Interchangeable Biosimilar Products for the first time since 2018. Biosimilar products are fairly new, with the first one being approved only 8 years ago. [1] Since that time, however, nearly 40 new biosimilar products have come to the market, leading the FDA to re-evaluate how it regulates these products.
Now you may be asking yourself – what exactly is a Biosimilar? A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in terms of safety, purity, and potency from an existing approved Biologic on the market. You can think of Biosimilars as products that utilize existing products like a predicate device in a 510k, except in this case the predicate would be called a “reference product”.
Biosimilars are approved via an abbreviated pathway, not a traditional BLA. Much like 510ks for devices, the abbreviated BLA pathway allows the manufacturer to demonstrate biosimilarity between the subject product and the reference product, instead of having to establish the safety and effectiveness of the biosimilar product independently. This means that you can drastically reduce the number of clinical trials that need to be conducted, which ultimately saves the manufacturer time and money.
The latest guidance update recommends removing details about the interchangeability from the label of biosimilar products. This is important because interchangeable products are another level of product. Biosimilar products, as discussed above, just need to demonstrate there are no clinically meaningful differences, however interchangeable biosimilar products must demonstrate that it will product the exact same clinical result. This is typically validated via switching studies, where you study the effects of switching between the biosimilar and the reference product as another arm of your clinical study.
As always, the FDA is looking to improve how it regulates innovative products, especially in the biosimilar space which is a rapidly increasing field. There are a number of nuances and details specific to each product, which makes the regulatory landscape even more tricky.
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[1] FDA (Dec 2022) Review and Approval retrieved on 09/20/2023 from: https://www.fda.gov/drugs/biosimilars/review-and-approval
