Biocon Biologics set to ramp up production of itolizumab

Biocon Biologics India Ltd will ramp up its capacity to produce itolizumab to avoid any shortage of the drug, which received approval from the Drug Controller General of India (DCGI) late last week for the treatment of a critical covid-19 symptom called cytokine storm, Biocon chairperson Kiran Mazumdar-Shaw said on Monday.

“We do have the capacity right now to address the present size of serious patients, but we do realize that this is a much bigger challenge, not just in India but for the world. We are going to ramp up capacity as much as possible and as fast as possible,” Mazumdar-Shaw said at a press conference.

Cytokines are signalling substances, such as interferon, interleukin, and others, which are released by the immune system in response to a viral attack. It has been observed that the novel coronavirus infection, in certain cases, causes an overproduction of cytokines, which can lead to excessive inflammation, organ failure and even death.

The drug was given the approval based on a 30-patient study in which all 20 patients who were given itolizumab recovered, while three of the 10 who weren’t given the drug died. Apart from the 20 patients, another 150 patients were also given the drug on compassionate grounds through ‘off-label use’—the term refers to the use of a drug in an emergency for a disease or medical condition that it is not approved to treat.

Mazumdar-Shaw and Sandeep Athalye, Biocon Biologics’ senior vice-president and chief medical officer, also defended the drug against experts’ criticism regarding the small number of participants in the study.

“This is a label extension of an existing product. So, we have a lot of safety information over the past seven years for this product,” Athalye said.

Upper respiratory infection is listed among the side-effects of the drug, as per the company’s website. However, the company did not comment on whether the side-effect could potentially have an impact on the treatment of covid-19, which is a respiratory disease.

Currently, the only drug used for treatment of cytokine storm is tocilizumab, which is sold by Roche subsidiary Genetech Inc. under the brand Actemra. However, as the drug is imported into India by Cipla, and not manufactured domestically, there has been a severe shortage. Even family members of patients were being asked by the hospitals to procure the medicine themselves.

Shortage of Actemra has led to significant black marketing of the drug at exorbitant prices. The drug is priced at ₹40,500 for a 400 mg dose, with prices in the black market at about twice the amount.

Treatment varies, with some being given just one dose, and others a second and final dose 24-48 hours later.

In contrast, Biocon Biologics’ itolizumab will be sold under the ‘Alzumab’ brand in vials with 25 mg drug for around ₹8,000 per vial. An entire course will consist of four vials, with each being given after a week’s interval, costing ₹32,000 for the entire treatment period.

Mazumdar-Shaw said the company will take measures to prevent black marketing of the drug, and will take action against all entities found to be selling it at a higher price.