Sept 15, 2016 (LBO) – Sri Lanka’s National Medicines Regulatory Authority says the Russian breast cancer drug registered under their authority is in line with guidelines.
The authority said they always follow the due process for registration of pharmaceutical products and “biosimilars.” Biosimilar is a biopharmaceutical drug designed to have active properties similar to one that has previously been licensed.
“The authority followed European Medicines Agency guidelines and scientific principals for registering the Russian manufactured trastuzumab biosimilar in Sri Lanka,” the authority said in a statement.
“To date more than 100,000 vials of the biosimilar in question has been administered to patients with breast cancer in Russia, about 25 percent suffering from early stage disease, without significant safety issues.”
The authority said unlike small-molecule drugs such as aspirin, which are produced via chemical synthesis, trastuzumab belongs to a unique class of agents known as biologics.
Biologics are complex drugs that are derived from living organisms such as bacterial cells.
The authority further revealed that another trastuzumab biosimilar manufactured by an Indian organization has also been submitted to them for registration.
“There have been a few issues related to its overall response benefit in the clinical trial reports provided to the authority.”
“We have raised them with relevant organization to resolve them.”
The authority said if satisfactory answers are provided, they will work towards registering the product in Sri Lanka.
In March this year a lawsuit filed against a local distributor of a Russian drug manufacturer, wanted a ban on the distribution of trastuzumab manufactured by a leading Russian biotechnology company.
In June, Sri Lankan Court of Appeals dismissed the lawsuit, lifting its earlier “stay order” on distribution and sale of two biosimilar drug products manufactured by the particular Russian firm in Sri Lanka.