Earlier this month, there were reports of the recurring problem caused by a biosimilar drug used to treat Age-related Macular Degeneration (AMD), an eye condition that causes vision loss among people aged 50 and older.

The issue came to the fore following adverse reactions (inflammation in the eyes) reported by patients. The incidents were consistent, well-documented and reported. But the biosimilar continued to be used, even at the cost of patient safety.

And that brings us to the question: are we giving enough attention to making quality products that are “safe” and “effective” and not just cheap and available especially in the context of biologics?

As defined by regulatory authorities, biologicals are medical products made from natural sources (human, animal etc) that help treat critical illnesses like cancers; they are different from conventional chemical drugs. Biosimilars are similar to but not identical copies of original biological products. But manufacturing these products is a challenge, as the molecules are big and complex and even a minor change in the manufacturing process can cause substantial changes in the final drug’s efficacy. That is why it is important to have vigilant and fool-proof procedures overseen by stringent, world-class regulatory guidelines.

Currently, there is a clear regulatory pathway for generic drugs once the patent protection on it expires. Around the world, physicians, health systems, and patients rely on less-expensive generics (chemically similar to an original medicine) to increase access to essential medicines.

Biosimilar pathways, though, are still evolving across the world, outlining how products compare to innovative biologic products and how they should be brought to market.

India has a big potential for biosimilars. But innovator biotherapeutics are unaffordable to the average patient in India, even though the price in the local market is usually lower than that in the West. The “Guideline on Similar Biologics: Regulatory Requirements Marketing Authorization in India for Biosimilar Drugs” was released by the Department of Biotechnology and the Central Drugs Standard Control Organisation to streamline the approval process and ensure high-quality biologics. However, these guidelines are yet to be fully implemented. And the dearth of resources and experience have led the Indian regulator to rely on regulations already in use in the developed world without customisation to local needs.

A host of regulatory and advisory bodies have been created by the government to address issues involving biologics.

Patients’ organisation too should be encouraged to report adverse events with the confidence that their voices will be heard and action taken. Without a strong system that gives the highest priority to safety and quality, we may be risking the long-term health goals of our citizens.

The writer heads the Indian Alliance of Patient Groups, an umbrella body of 12 patient groups working in the areas of rare disorders and chronic diseases.

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