Biocon Ltd ill seek Drug Controller General of India's approval for its novel monoclonal antibody indicated towards the treatment of head and neck cancer, Biomab EGFR.
"We will be submitting an application for approval to DCGI shortly and hope to be on target to launch 'BIOMAb' by this year end," Biocon CMD Kiran Mazumdar-Shaw said.
Biocon's Cuban partner, CIMAB has got marketing approval for the molecule in China, Argentina, Colombia and Cuba, she said.
Confirming the marketing approval of its Cuban partner CIMAB, which originally identified the BlOMAb EGFR molecule, she said: "We have marketing rights for India and South Asia... we also have global manufacturing rights."
On Biocon's plans for the US market, she said the company does not have the rights to market the molecule in the US.
"We do not have rights for the US market but we hope to qualify as a supplier of the molecule there," Shaw said.
Asked about the impact BlOMAb EGFR will have on revenues of Biocon in next two-three years, she said: "Full impact on revenues from Biomab EGFR will be seen over the next few years."
The final product when launched would spearhead Biocon Biopharmaceuticals' foray into proprietary products for cancer therapy in the country.
Clinical trials of the molecule were conducted at Manipal Hospital in Bangalore and KMC hospitals in Mangalore and Manipal.
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