Biopharma company Biocon has tied up with Mexico's Laboratorios PiSA S.A. de C.V (PiSA) to jointly develop and sell a generic recombinant human insulin in the United States, a $2-billion market, one of the largest for insulin worldwide.
Biocon expects the insulin product by 2020 in the US, which accounts for nearly 40% share of the global $ 5 billion insulin market.
PiSA, a market leader in Mexico, is an existing partner for over a decade with Biocon. 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, the company said in a statement.
“The insulin market is dominated by a handful of players - Novo Nordisk, Eli Lilly and Sanofi. We believe we have the capacity and the size to play a significant role in the insulin market in the world," Kiran Mazumdar-Shaw, Biocon Chairperson and managing director told a conference call on Thursday.
"It is an expensive process. All the biosimilars development for the US market is upwards of $ 30 million. We have tied up with PiSA where we get added advantage of cost of commercialisation" she said.
Biocon has a cost and profit sharing model with PiSA, which will make the final product for the US market. The India and the upcoming Malaysian facility will produce the drug substance.
The Bengaluru-based Biocon already has over 50% market share in RH insulin in Mexico and nearly 30-40% share in southeast Asia and other Latin American markets.
“The US is the best market for RH human insulin because of the pricing. It is a over-the-counter (OTC) and institutional market. It plays well for Biocon's strength, said Shaw.
Biocon, which had completed phase three trials in Europe for the RH insulin, would now use data from the trials to develop the insulin for the US after new European guidelines made the market unattractive for the company.
"Today, the price point for RH insulin in the US is over $ 100, in India, it is a fraction of it. Obviously, development costs for the US will make it more expensive than the Indian price," said Shaw. "We see an opportunity to market it in the US with a judicious discounting of the product."
