Biocon’s wholly owned subsidiary Biocon SA has entered into an agreement with Laboratorios PiSA S.A. de C.V (PiSA) of Mexico for the co-development and commercialisation of generic recombinant human insulin (rh-insulin) for the US market. This regulated region accounts for over 40 per cent opportunity of the total US$5 billion global market which is US$2 billion. The partnership ensues the US biosimilar guidelines which are making it clearer for products like rh-insulin. The product will be made available before 2020.

US has an attractive price point for generic rh-insulin and the company is eyeing the over-the-counter and institutional sales. The PiSA partnership is an extension of our presence in Mexico. Our long standing relationship of over 10 years with PiSA, who has a dominant position in insulins in Mexico and our trusted partner, said Kiran Mazumdar-Shaw, chairperson & managing director, Biocon.

In fact, Biocon's insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing affordable access to insulins to patients. It is a cost and profit sharing agreement with the Indian biotechnology major which will in-charge of clinical development, regulatory approvals, and product  commercialisation in the US.

The rh insulin drug substance will be sourced from Biocon’s manufacturing facilities and PiSA’s  plant in Mexico for final product. The pact will maximise  PiSA’s proximity to the US market and Mexico’s NAFTA membership. It will ensure an efficient and optimal supply chain to address the needs of the US healthcare system for an affordable, high quality rh-insulin, she added.

US has a huge diabetes burden with over 1.4 million people diagnosed with annually. Moreover the global clinical development experience with insulin Glargine for the US will be a useful precedent in developing rh-insulin in this market. The rh insulin costs $100 in the US and its development costs are high, but it is cost-effective to manufacture in Mexico, she said.

“Applying PiSA’s world class, sterile injectable and biotechnology development & manufacturing capabilities to contract manufacture Biocon’s generic rh- insulin products represents a major milestone in PiSA’s strategy to enter the US sterile injectable market,” said Carlos Alvarez Bermejillo, chairman & president, PiSA.

“We have been marketing insulin products based on Biocon’s high quality APIs for many years, hence this partnership to develop generic rh- insulin products represents the natural progression of a strong relationship between the two firms,” he added.

Biocon is recognized as Asia’s largest insulins producer and has been committed to provide 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.