Biocon & Mexican company tie-up to develop insulin for US market

Biocon will be responsible for clinical development, regulatory approvals and marketing of the insulin in the US, as part of the cost and profit-sharing agreement.

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March 18, 2016

To co-develop generic recombinant human insulin for the US market, biopharma major Biocon was tying up with a Mexican firm.

Biopharma major Biocon on Thursday announced that its subsidiary was tying up with a Mexican firm to co-develop for the US market.

In a statement the company said, “The tie-up with Laboratorios PiSA S.A. de C.V of Mexico is part of our strategy to address the demand for generic rh-insulin in the US, which accounts for 40 percent ($2 billion) of the $5 billion global market.”

The partnership envisages leveraging Biocon’s plant for the drug substance with PiSA’s product facility, its proximity to the US market and Mexico’s NAFTA (North American Free Trade Agreement) membership that ensures optimal supply chain to meet the needs of the US healthcare system for an affordable rh-insulin.

Biocon will be responsible for clinical development, regulatory approvals and marketing of the product in the US, as part of the cost and profit-sharing agreement.

The agreement is an extension of our decade-long partnership with PiSA, which dominates the insulin market in Mexico. Our insulin Glargine was the first to be approved in Mexico last year,” company’s chairperson Kiran Mazumdar-Shaw said.

Biocon’s global clinical development experience with Glargine will be a useful precedent in developing rh-insulin for the US market.

“The collaboration with PiSA also enables us to manufacture the rh-insulin drug product at PiSA’s facilities in Mexico and commercialise it under our brand in the US where 1.4 million people are diagnosed with diabetes every year,” Shaw said on the occasion.

According to PiSA chairman Carlos Alvarez Bermejillo, the partnership with the Indian company is a milestone in his company’s strategy to enter the US sterile injectable market.

“As we have been marketing similar products based on Biocon’s API for many years, the partnership to develop generic rh-insulin products represents a natural progression of a firm relationship between the two firms,” Bermejillo added.

Here is an excellent post on products developed by the company.

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1. IANS