Biocon, a Rs.2850 crore Asia's premier biopharmaceuticals company, has received approval for its insulin glargine by COFEPRIS, the Mexican Health Authority, through its partner PiSA Farmaceutica (PiSA).

Mexico has been a very important market for Biocon since 2006, where it has been playing a significant role in enabling access to affordable rh-insulin. Insulin glargine will augment the affordable insulins therapy for diabetes management. ‘Galactus’ by PiSA is the first insulin glargine to be approved in Mexico as per the biocomparable approvals pathway defined in 2012.

Biocon is recognized as Asia’s largest insulins producer and has been committed to affordable diabetes management through rh-insulin (Insugen) and insulin glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for insulin glargine.

Biocon chairperson & managing director Kiran Mazumdar-Shaw said: “We are committed to make global impact with our affordable insulins therapy. Our insulin glargine, will now enable access to a basal insulin which will further expand the diabetes management therapy for patients in Mexico.”

Ravi Limaye, president - marketing, Biocon said: “With insulin glargine approval in Mexico we have expanded our insulins global footprint. Along with our partner PiSA we will be able to enhance the reach of our affordable insulins therapy in the country.”

PiSA Group executive vice president Lic. Santiago Alvarez Vega said: "We are extremely excited to partner with Biocon to introduce Galactus, the long acting insulin glargine in Mexico, which has a disease prevalence of 12%, the second highest in the world. We hope to enable the government to bring down its per capita expenditure on diabetes with the use of this cost effective, high quality biocomparable insulin glargine”

Diabetes is a major health risk in Mexico, over 70 per cent of the Mexican population is overweight thus prone to developing diabetes. With over 9 million cases of diabetes, it poses a huge disease burden for the government with per capita expenditure on diabetes being as high as USD 892.5. As per available data it is a leading cause of mortality in the country. (Source: IDF).

Biocon’s presence in Mexico, over the last eight years, has expanded the insulins market substantially by initiating many more patients onto insulin therapy. The increasing affordability of insulin glargine will now enable Biocon and PiSA to expand this reach further. The combined market for insulin glargine in Mexico is estimated to be in excess of USD 40 million.

PiSA Farmaceutica, established in 1945, is a privately held leading Mexican pharmaceutical company that has its strong presence in the Mexican market and select Latin American countries. With products like Agrifen, Cefaxona, Electrolit, Insulex and Dextrifyl PiSA has been successfully creating top brands in the Mexican markets. PiSA has also established itself as a leading company for treating renal diseases through its reliability in peritoneal dialysis and haemodialysis.