Monoclonal antibodies: a promising pharmaceutical product

India, the “vaccine capital of the world” (despite the current shortage of Covid-19 vaccines), may become a world leader in another product: monoclonal antibodies. The pandemic has propelled India onto the launch pad for a leadership position in products such as ventilators and oxygen concentrators. Monoclonal antibodies (mAbs) join the list.

Monoclonal antibodies, as a class of drugs, are gaining ground around the world. Recently, the United States Food and Drug Administration approved its 100th mAb. Today, mAbs represent one-fifth of all new drug approvals from the FDA.

In India, MAbs have been pushed into the mainstream discourse by the pandemic and people have become familiar with names such as Tocilizumab, Itolizumab, Casirivimab, and Imdevimab. Previously, only doctors knew these names.

What are monoclonal antibodies? We know that antibodies are substances (Y-shaped proteins) produced by our body’s immune system, which destroy invading pathogens. Monoclonal antibodies are antibodies produced in the laboratory using living cells. These medicinal products therefore fall under the heading “biological products”, which are medicinal products produced exclusively from living organisms. They can also be “biosimilars” – biologics “similar” to another “reference” biologic drug.

Obviously, making mAbs is difficult because they are very complex molecules. An ordinary medicine molecule can have about 20 to 25 atoms; a mAb has about 25,000 atoms, says Roche, the Swiss company that funded the Basel Institute of Immunology, whose scientists Georges Köhler and César Milstein developed a process to produce mAbs and won the Nobel Prize in 1984.

Covid-19 and mAb

Doctors have tried MAbs to treat Covid-19; this is how they became part of the pandemic narrative. However, these are used in some specific cases of infections. MAbs do not kill viruses, but are useful when the body’s immune system overreacts and produces a profusion of antibodies – called cytokine storms – which can lead to antibodies attacking healthy cells (autoimmune). Dr R Narasimhan, pulmonologist and chairman of the Chennai-based Indian Respiratory Research Foundation, says he uses mAbs to treat severe cases of Covid-19, to reduce the extent of infection.

In India, Roche’s Tocilizumab (distributed by Cipla) is a leading drug, but there are others in the mix. Biocon is stepping up production of Itolizumab due to growing demand. Earlier this month, India’s Central Drugs Standards Control Organization granted “emergency use authorization” for a cocktail of two antibodies – Roche’s Casirivimab and Imdevimab. This cocktail, Roche said, “may play a role in the fight against Covid-19 and in treating high-risk patients before their condition worsens.”

The relevance of mAbs for Covid-19 is still unclear. Many, like Narasimhan and Dr Sridhar Nagaiyan, an intensive care specialist who treats Covid-19 patients at Kauvery Hospital in Chennai, say MAbs are helpful in a small group of cases. On the flip side, the makers of drugs like Biocon are bullish about them. GAVI, the global vaccine alliance, says some 70 mAbs are under development for Covid-19 treatment.

However, what is not in dispute is that mAbs are a fast growing class of drugs. In 2019, seven of the top ten best-selling drugs were mAbs. In February, a research report from indicated that the mAbs market would reach $ 161.7 billion by 2024, with a CAGR of 7.21% between 2020 and 2024.

This is the market that India can conquer. Dr Sandeep Athalye, medical director of Biocon, sees a “big role” for Indian companies in mAbs.

Some illustrative figures, cited by GAVI, explain why. Canmab, a biosimilar version of the breast cancer drug Herceptin, sells for $ 100 to $ 200 a dose in India; in the United States, a dose costs $ 1,800. GAVI also notes that India stands out among low- and middle-income countries because of its local manufacturing capacity, with around 100 companies producing biosimilars.

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