The deal, announced yesterday, will net Biocon SDN. BHD – a subsidiary of Indian drugmaker Biocon – MYR 300m ($68m) for supply of its rh-insulin and pen delivery device to local firm CCM Pharmaceuticals for distribution to service primary healthcare clinics and hospitals across Malaysia.
“We would be providing ‘Made in Malaysia’ rh-insulin cartridges and pens to meet the needs of the government of Malaysia,” a Biocon spokesperson told in-Pharmatechnologist.com. “The contract value is of MYR 300m to be serviced over a period of three years, extendable for two years subject to government approval.”
The amount of insulin API or number of finished products to be supplied was not divulged, but both will be made at Biocon’s facility in Johor, Malaysia which was commissioned in 2010 and was certified by Malaysia’s National Pharmaceutical Regulatory Authority (NPRA) in 2015. Biocon has invested around MYR 1.1bn into the site, and
“The Malaysia manufacturing plant has been set up to address the needs of people with diabetes globally including that of Malaysia,” we were told. “The contract has been awarded post all regulatory compliances, and there was no automatic assured award of contract.”
Insulin biosimilar and global market
The site has also been allocated by the company to supply its insulin glargine – co-developed with Mylan – in Europe. The product, submitted as a biosimilar of Sanofi’s Lantus is under review by the European Medicines Agency (EMA).
“Our Malaysian facility is Asia’s largest integrated Insulins manufacturing facility,” the spokesperson said, “and has adequate capacities to not only service this contract but also to meet growing needs of affordable insulins and analogs in other emerging markets.
“Several regulatory filings across developed and emerging markets are already underway to enable sales to these markets from the new Malaysian manufacturing facility.
CORRECTION - The original article said in the second paragraph that Biocon was to supply of glargine insulin, when in fact this contract is for rh-insulin