The importance of bioequivalence (BE) arose in the 1980s as many of the first innovator therapeutics began to reach the end of their patent windows. This saw the rise of generics. By 2009, generic prescriptions made up 2/3 of those filled in the US, but represented just 13% of the costs. BE presents a vital methodology to ensure the safety and efficacy of these generics without requiring expensive clinical trials, reducing the cost of the therapeutic for the end user.
BE is vitally important for improving access to therapeutics by removing the need for expensive clinical trials. But how does it work? In short, the goal of a BE study is to show that the product under investigation behaves identically – or near enough – to a previously approved product when used as a therapeutic.
This is far faster and less expensive than a typical licensing process. For example, in the US – under the jurisdiction of the FDA – a novel therapeutic can apply for regulatory approval under a New Drug Application, or NDA. This can take several years or even decades from discovery to approval, including several rounds of clinical trials. By contrast, a generic drug can be approved under an Abbreviated New Drug Application, or ANDA, which cuts out the requirement for clinical trials in favour of a bioequivalence study.