In an effort to address the rising demand for insulin, Biocon SA, the subsidiary of Biocon, has entered into an agreement with Mexico-based Laboratorios PiSA.
As per the partnership Biocon will manufacture rh-insulin, a substance that goes into the insulin, while PiSA will manufacture drug product at its facilities in Mexico. Further, the insulin will be commercially sold in the US market.
In a conference call, Kiran Mazumdar-Shaw, Chairperson and MD, Biocon, said that this is extremely important as the company is focussed on globalising its insulin portfolio. Add to that the demand for generic rh-insulin is estimated at $2 billion annually, which is 40 per cent of the global demand.
Biocon’s entry into the US will also result in lower insulin prices in a market that does not have a generic version and is currently dominated by pharma majors such as Eli Lilly, Novo Nordisk and Sanofi. Another reason for the launch at this time has to do with clearer guidelines on biosimilars emerging in the US.
Both companies are looking to provide ‘affordable’ access to insulins, added Shaw. As an example, she pointed out that the cost of insulin runs anywhere from $100 upwards and there is a lot of room to reduce costs. Biocon, however, did not quantify the extent to which costs can be reduced.
It is confident that its longstanding partnership with PiSA, which dates back to a decade, coupled with its insulin Glargine (which was first approved in Mexico last year), puts it in an advantageous position.
Also, PiSA proximity to the US and Mexico's NAFTA membership are key factors too, company officials said.
Typically, Indian companies have been weary of getting into generics insulin due to factors such as cost of R&D and high cost of doing business.
In this cost and profit sharing agreement, Biocon will be responsible for clinical development, regulatory approvals, and commercialisation of the product in the US.
“The co-development will help us to distribute costs and we get the added advantage of commercialising it,” said Shaw.
These efforts are a part of Biocon’s strategy to strengthen its biosimilars and generic insulin business. In January, Biocon announced that it will conduct the next phase of clinical trials for its oral insulin Tregopil.