Biocon NSE, the Bengaluru located biopharmaceutical company is taking on Swiss drugmaker Roche Pharma. It will take on with its psoriasis drug itolizumab. Itolizumab received emergency drug approval from the Drug Controller General of India.

Physicians were surprised by the limited number of patients for the trial of the drug as on this basis the company is marching on. However, Biocon expressed that any emergency condition always fetches a small-sized trial.

Biocon said that the drug is the first biologic to get approval in the world for the treatment of moderate to severe Covid-19 patients.

Biocon is marketing the drug as a replacement to Roche’s tocilizumab (which was previously approved for rheumatoid arthritis), is presently in off-label use (using a drug for an unapproved indication) among Covid-19 patients that are suffering from cytokine release syndrome (CRS) or “cytokine storm”.

When a protein called IL-6 mounts an immune response to infections, CRS happens. As some of the Covid-19 patients are having extremely high levels of IL-6, they get inflammation of the lungs and death occurs.

Tocilizumab is costly (INR 45,000 for a 400mg) vial for patients. Patients might require two vials, and itolizumab is pegged at INR 32,000 for four vials.

Kiran Mazumdar Shaw, Chairman, Biocon, said, “It is an emergency condition and so the size of the trial is small. For this reason, the medicine is given restrictive emergency use of approval. The process of regulation is totally robust and scientific discussions involved high order thinking skills.” Receiving a phase-3 waiver for the drug, now Biocon is doing phase 4 after marketing surveillance of the drug’s effectiveness.