Why Renata invested heavily in developing 100 bioequivalent medicines

Since 2015, Renata PLC has invested hundreds of crores of taka to strengthen its research and development. A team of nearly 200 scientists, most of them in their twenties and thirties, has so far developed 100 bioequivalent products.

This team is a wonderful manifestation of Bangladesh's oft-quoted demographic dividend. Their output paves the way for stamping "Made in Bangladesh" on potentially 100 global products.

So, what exactly is the big deal about bioequivalence?

At the risk of sounding like a used-car salesman, bioequivalence is the silent guarantee behind every generic drug. But in all honesty, there is real science backing this marketing spiel.

Consider how innovator products such as Viagra, Crestor and Nexium get approved. The inventor companies run extensive clinical trials to prove efficacy and safety. Apart from draining company coffers, these trials often take ten years or longer.

On the other hand, generic drugs can skip this elaborate process, provided there is proof of bioequivalence.

Essentially, it needs to be shown that the generic delivers the same amount of active drug into the bloodstream at the same rate as the innovator's product. So, both the quantity of the drug and the speed of absorption matter.

Once these two criteria are satisfied, most of the work is done. The generic can legitimately claim to work in the body in the same way as the innovator drug. There is no need to repeat the expensive and time-consuming clinical trials done by the discoverer.

However, there are no shortcuts to establishing bioequivalence other than testing the drugs on human volunteers. Typically, 24 to 36 volunteers take both versions, and statistical tests determine whether the two are equivalent.

These studies are not cheap. Depending on the drug, a biostudy costs $100,000 to $250,000 or more.

Bioequivalence has been the global standard since 1984. However, because of the heavy expenditure involved, regulatory authorities around the world took time before making it a prerequisite for registering generic drugs.

Just to be clear, generic medicines that are not bioequivalent are quite serviceable. They are still life-saving and quality-of-life-enhancing for millions of people. It is just that chemical tests at laboratories are, more often than not, imperfect substitutes for studies on human volunteers.

However, the regulatory landscape is changing fast. Bioequivalence is not only mandatory in developed countries but is also becoming the rule in most Asian, African and Latin American countries. It is just a matter of time before Bangladesh follows suit.

This is why Renata made the bet it did. The bet is part of a larger shift, one that has been reshaping the industry for decades. For companies with global ambitions, the message is clear: bioequivalence is no longer an advantage to aspire to; it is a licence to compete.

Kaiser Kabir is the CEO of Renata PLC

Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the opinions and views of The Business Standard.