How does Bioequivalence create value addition in Generics?

The concept of Bioequivalence has recently garnered considerable interest within the Bangladeshi pharmaceutical industry. However, what does the term really mean and why is it such a massive value addition to a product when it is classified as such? When a generic drug is approved as bioequivalent to its brand-name or innovator counterpart, it means the generic version releases its active ingredient into the bloodstream at virtually the same rate and amount as the original drug. This has to be clinically demonstrated by bioequivalence studies where volunteers or patients are dosed with both the innovator product and generic product, allowing for a comparative measurement of the amount and pattern of drug released in the blood. If a generic is labeled as bioequivalent, it is clinically proven to have the same efficacy and safety as the innovator, therefore allowing for seamless substitution of generic drugs for brand-name drugs. At the end of the day, this allows for a means of providing patients with more affordable treatment options without compromising therapeutic outcomes. Therefore, bioequivalence plays a crucial role in ensuring the quality, safety, and efficacy of generic pharmaceutical products.

Bioequivalence is however not easy to establish at all - it is time consuming, resource consuming, expensive, requiring even the centers conducting the studies to have regulatory approvals and certifications in place from health authorities. For the purpose of allowing greater access to cost effective medicines by a wider population, bioequivalence is not a mandatory regulatory requirement by the health regulatory authorities of all countries worldwide - Bangladesh being one of them. While bioequivalence studies are required for certain categories of drugs, such as those with narrow therapeutic indices can become toxic with a small increase in dosing, some generic products may be approved based on other criteria, such as compliance with good manufacturing practices and? pharmaceutical equivalence in vitro (demonstrated by laboratory findings) .

It is imperative to note that in territories that are often labeled as governed by “Stringent Regulatory Authorities” such as the US FDA for the US, or Therapeutic Good Administration (TGA) for Australia, bioequivalence is mandatory for any and all generic approvals. A product that has not demonstrated bioequivalence against an innovator product would not even be allowed to be marketed in these territories. Given how Renata is continually striving for expansion into new territories including stringent regulated markets, quality assurance of pharmaceutical products backed by evidence has become the most crucial and competitive factor. Therefore, bioequivalence can easily become the distinguishing factor for a company that can support interchangeability and claim their product is as good as an innovator/branded product.

Renata playing a significant role in this arena , which has a portfolio of 70+ bioequivalent products, being present in 43 countries through partnerships and having 24 products approved by Stringent Regulatory Authorities. Renata PLC endeavours to make bioequivalence a hallmark of its quality assurance and world class manufacturing and formulation capabilities. As a company founded in a developing nation, the importance of bioequivalence is paramount in establishing a strong and commendable reputation of Bangladeshi Pharmaceutical companies in the global pharmaceutical landscape.