Updated on 21 August 2013
Dr Kiran Mazumdar-Shaw, CMD, Biocon, India
After geting the regulatory approval in early 2013, Biocon, India's number two biotech company by revenues, released the much awaited Itolizumab with the brand name Alzumab in India on August 9. The monocolonal anti-body, the second novel biological drug developed entirely in India, is an anti-CD6 antibody based product.
"Biocon's Alzumab is the first anti-CD6 monoclonal antibody to be commercialized, an outcome of path breaking research in India," said Biocon's CMD, Kiran Mazumdar-Shaw, while launching the product in Bangalore on August 10. "We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world."
A vial of the injectible medicine ( 25 mg/5 ml) will cost $131 (INR 7,950) compared to four other multinational products currently available in the Indian market at more than double this price. A patient has to take 28 injections and 12 maintenance shots every alternate weeks over 24 weeks. The approximate cost of treatment will be $5,243 (INR 3.2 lakh).
More than the cost, Alzumab is believed to be better than the existing biological products such an Enbrel (Pfizer), Humira (Abbott), and Remicade, because studies indicate that there are no appreciable side-effects. On the other hand, other drugs are known to reduce immunity and increase the incidence of tuberculosis in many patients. These are a class of anti-immune drugs which treat all such diseases.
Biocon started work on this drug more than 10 years ago, said Mazumdar-Shaw, and the drug went through one of the largest clinical trials for a biological drug in the country. More than 400 patients in the age group of 18 to 65 were enrolled for the trials. She said patients with Alzumab showed remission only after 24 weeks compared to 5-20 weeks in the case of existing drugs. A woman patient enrolled in the trial showed 97 per cent improvement after eight weeks of treatment and no relapse occurred even after six months.