'We do have capacity right now to address the present size of serious patients but we do realise 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,' Kiran Mazumdar-Shaw said
Biocon Biologics India Ltd will ramp up its capacity to produce itolizumab at its plant to avoid any shortage of the drug, which late last week received an approval from the Drug Controller General of India’s office for treatment of a critical covid-19 symptom called cytokine storm, chairperson Kiran Mazumdar-Shaw said on Monday.
“We do have capacity right now to address the present size of serious patients but we do realise 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 activity. 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 an approval based on a 30-patient study in which all 20 patients that were given itolizumab recovered, while three of the 10 that 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 & chief medical officer also defended the drug against experts’ criticism against 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," Athawale 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, a respiratory disease itself.
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 for the drug in the country, with some kin of patients also 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 per vial of 400 mg drug, with prices in the black market at about twice the amount.
Treatment courses vary, with some being given just one dose, and others a second and final dose 48 hours after the first.
In contrast, Biocon Biologics’ itolizumab will be sold under the brand ‘Alzumab’ in 25 mg vials at around ₹8,000 per vial. An entire course will consist of four vials, with each being given after a week’s interval, leading to the cost of ₹32,000 for the entire course.
Shaw said that the company will take steps to prevent black-marketing of the medicine, including taking action against entities found black marketing.
The Drug Controller General of India V.G. Somani had written a letter last week to state regulators and the National Pharmaceutical Pricing Authority to remain vigilant against overpricing and black-marketing of covid-19 drugs, including tocilizumab.
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