Sandoz has launched its version of the biosimilar Pegfilgrastim in the US market. Kiran Mazumdar Shaw, chairman and managing director of Biocon, shared her views and outlook on the pharmaceuticals market in an interview with CNBC-TV18.

“I certainly believe that global healthcare has an increasing demand on generics and we know that India has a leadership position in the generic market globally. China has also opened up significantly for Indian companies and I believe that this augurs very well for the growth of this sector. Additionally, we as a biopharmaceutical company are seeing that we have an expanding market place for our biosimilars and we are very confident of the growth prospects that our biopharma, biosimilars have in the coming future,” she said.

On regulatory and compliance issues within the US, she said: “This is something which we have to accept. There is going to be more stringency in the expectations from the US Food and Drug Administration (USFDA). Given that, this particular sector has not had that kind of forensic scrutiny in the past, we have to accept it as a new normal. We just have to get ourselves upgraded for that.

“I think the agency today does expect us to look at automation, look at various interventions that reduce human error. Let us face it. We are seeing a lot of human error and that it is only not Indian companies that are getting warning letters, we have to also understand that many US companies are also getting warning letters. So this is a global expectation level being set by US FDA. Let us not look at it as an India-centric kind of phenomenon. This is a global phenomenon, USFDA has upped the bar for compliance and you can see that because US has many more inspections and there are many more companies, they have many more warning letters,” she further mentioned.

On the competition from Sandoz for Pegfilgrastim, Shaw said, “I believe that the market is very large. Mylan is doing an excellent job in marketing pegfilgrastim in the US market. Very soon we are going to be boosting our sales in the US market. We had capacity constraints up until now but that capacity had been expanded and put in to place. We are very confident that we will continue to grow. There are still very few approvals in the US and having just four-five players doesn’t change the competitive landscape that much but as a Mylan-Biocon combination, we are very confident that we can have a good market share in the US market.”

On insulin Glargine, she said, “We are on track and we believe that this is an opportunity which we must pursue very aggressively. We do hope that starting next fiscal, we will be able to see some indicators of how insulin Glargine is doing in the US market.

“The listed Biocon has a huge future in terms of our small molecule generic APIs, which is showing robust growth. Plus if you look at the Biocon Ltd, the listed company, it becomes a very balanced portfolio offering,” she said.