New Delhi: Biotechnology major Biocon has entered into an agreement with Laboratorios PiSA for co-development and commercialisation of generic recombinant human insulin for the US market.
“This collaboration is a part of Biocon’s strategy to address the large demand for generic rh-insulin in the US, which accounts for over 40 per cent of the global sales of $5 billion,” Biocon said in a statement.
The company’s wholly-owned subsidiary Biocon SA has entered an agreement with Laboratorios PiSA S.A. de C.V (PiSA) of Mexico for co-development and commercialisation of generic recombinant human insulin (rh-insulin) for the US market, it added.
“This is a cost and profit sharing agreement with Biocon, responsible for clinical development, regulatory approvals, and commercialisation of the product in the US,” Biocon said.
The company however did not disclose the financial details of the agreement. This partnership will leverage Biocon’s manufacturing facilities for the drug substance and PiSA’s drug product facilities in Mexico, it added.
“This collaboration will enable us to manufacture the rh-insulin drug product at PiSA’s facilities in Mexico and commercialise it under Brand Biocon in the US market…,” Biocon chairperson & MD Kiran Mazumdar-Shaw said.
Biocon’s partnership with PiSA demonstrates its commitment to provide access to affordable insulins to patients in the US, she added.
“Applying PiSA’s world class, state-of-the-art sterile injectable and biotechnology development and 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,” PiSA chairman & president Carlos Alvarez Bermejillo said.
PiSA has been marketing insulin products based on Biocon’s API 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.
The partnership is an extension of the company’s relationship of over 10 years with PiSA, which has a dominant position in insulins in Mexico, Biocon said.
Biocon has been committed to providing affordable diabetes management through rh-insulin (Insugen) and insulin glargine (Basalog) in India and several emerging markets, the company said.
Biocon has marketing approvals in over 60 countries for rh-insulin and in over 20 countries for insulin glargine.