The Russian drug firm announced it had started shipping the drug – known as HERtiCAD – this week, which is just a month after it was approved by Sri Lankan regulatory agency, the Cosmetic Devices and Drugs Regulatory Authority (CCDA).
The drug, which is made at Biocad’s manufacturing facility in St Petersburg will be distributed in Sri Lanka by a local partner under an agreement signed in 2014.
However, the record has not been updated since February last year.
Biocad also plans to launch several other biosimilar monoclonal antibodies (mAbs) in Sri Lanka in the next few years.
HERtiCAD was approved by Russian authorities in January.
At the time Biocad spokeswoman Irina Kenyukhova told us “federal regulations require the first bioanalogue to be at least 10% cheaper than the original product.”
According to an entry on clinicaltrials.gov HERtiCAD – which is also known as BCD-022 – was being examined in a Phase III clinical in breast cancer at sites in Russia, Belarus, Ukraine and India.