Biocon Gets India Approval for Psoriasis Drug-----CMP 277.75
BANGALORE–Biocon Ltd. 532523.BY -0.96% Tuesday said it has received Indian regulatory approval to sell Itolizumab, a new biologic drug to treat psoriasis.
Biocon added that it aims to start selling the drug later this year.
The company is a front-runner among Indian firms developing biological treatments, which use proteins manufactured in living cells rather than chemical-based drugs.
Itolizumab belongs to a class of biopharmaceuticals known as monoclonal antibodies, which can be designed to target specific proteins in the body that play roles in the development of various diseases.
They are used to treat certain autoimmune diseases and some types of cancer.
Autoimmune diseases are those where the immune system mistakenly attacks and destroys healthy body tissue.
Psoriasis, an autoimmune skin disease, affects 2%-3% of India’s more than 1.2 billion people, Biocon said, adding that the global market for psoriasis treatments is estimated to cross $8 billion by 2016.
Itolizumab is the second novel biologic drug that Biocon has developed in India. BioMab EGFR, an anti-cancer monoclonal antibody, was the first.
Biocon said a launch in India will pave the way for the company to file an investigational new drug application with the U.S. Food and Drug Administration seeking authorization for further human trials.
Biocon plans to develop the drug with a global partner for various markets.
--------------Source Global regulatory science
BANGALORE–Biocon Ltd. 532523.BY -0.96% Tuesday said it has received Indian regulatory approval to sell Itolizumab, a new biologic drug to treat psoriasis.
Biocon added that it aims to start selling the drug later this year.
The company is a front-runner among Indian firms developing biological treatments, which use proteins manufactured in living cells rather than chemical-based drugs.
Itolizumab belongs to a class of biopharmaceuticals known as monoclonal antibodies, which can be designed to target specific proteins in the body that play roles in the development of various diseases.
They are used to treat certain autoimmune diseases and some types of cancer.
Autoimmune diseases are those where the immune system mistakenly attacks and destroys healthy body tissue.
Psoriasis, an autoimmune skin disease, affects 2%-3% of India’s more than 1.2 billion people, Biocon said, adding that the global market for psoriasis treatments is estimated to cross $8 billion by 2016.
Itolizumab is the second novel biologic drug that Biocon has developed in India. BioMab EGFR, an anti-cancer monoclonal antibody, was the first.
Biocon said a launch in India will pave the way for the company to file an investigational new drug application with the U.S. Food and Drug Administration seeking authorization for further human trials.
Biocon plans to develop the drug with a global partner for various markets.
--------------Source Global regulatory science
