However, any negative impact on generic suppliers here is ruled out, says Kiran Mazumdar Shaw, CMD of Biocon .
She said she completely agrees with Trump’s view but doesn’t see his views affecting Indian pharma.
“I don’t think these are going to be big issues; if Indian pharma companies are supplying these products to the US markets and if there are no US suppliers, which is mostly the case, this doesn’t affect the Indian pharma companies,” she said.
Biocon on Wednesday said the US drug regulator has accepted its partner Mylan’s biologics licence application (BLA) for the proposed biosimilar of breast cancer drug trastuzumab through the 351(k) pathway.
This product is a proposed biosimilar version of Roche’s Herceptin, which is indicated to treat certain HER2-positive breast cancers.
“The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017,” Biocon said in a statement.
Speaking about the application, Shaw said that it offers huge potential for the company. Admitting that it won’t give them the advantage that generics enjoy, the upmarket opportunity however is pretty attractive. The market is worth about USD 7 billion globally, she said. “This will make a big difference to cancer patients in the US.”
She hopes that drug approval and marketing efforts will be completed before 18 months. Revenues from it will hopefully start kicking in from FY19, she said.
Transcript to follow…