Dr Reddy’s looks to bring biosimilars to EU within five years
The company has launched four biosimilars in India, Peru, Sri Lanka and other emerging markets, though the manufacturing facilities it uses to produce these biosimilars will not be used for the US and EU. For the EU, Merck Serono, which has partnered with Dr. Reddy’s on bringing the follow-on biologics to market, will manufacture the biosimilars once approved.
Satish Reddy, Dr Reddy’s vice chairman and managing director, sat down with BioPharma-Reporter.com for an exclusive interview in his office in Hyderabad and provided us with an update on the company’s efforts in biosimilars. The interview is lightly edited for clarity.
BPR: Can you provide some background on Dr. Reddy’s biosimilar manufacturing and development?
Reddy: “Our entry into biosimilars started almost 15 years back. The biggest success was when we developed and launched Rituximab in 2006, so the significance of that was it was the first in the world for Rituximab. Currently we have four [biosimilar] products on the Indian market and several others are in development.
“So as for the company, in terms of capabilities, development and manufacturing are all in-house. Even as we speak we’re expanding manufacturing capacities for Rituximab with increased volumes coming in from various markets.” He noted that the price of Rituximab in India is about one-third the price of what Roche charges.
“As for the more developed markets, the EU approval pathway is quite clear, especially for monocolonal antibodies,” he added.
BPR: What kind of technology are you using and developing for biomanufacturing?
“In terms of manufacturing, the biggest thing is really the expertise because you didn’t have that kind of base in India in the past,” Reddy said. “When we went into monoclonal antibodies it took a much longer time – for the time when we started development to ultimately getting into the market took us six years. And then we kept expanding.
“We’ve just opened a new [biopharma manufacturing] facility so this expansion will continue. If we were to manufacture for developed markets, the requirements would be much more difficult but that’s going to be taken care of by Merck Serono.”
And how is your biosimilar partnership with Merck Serono progressing?
Reddy: “The way the partnership works is that we have the products, so we’re transferring the technology to Merck Serono who will then manufacture it for us in the developed markets. They’ll help us through the clinical and regulatory, we’ll split the costs, and then we have milestone payments. All of this is for Europe, which will take about four or five years to come to market.”
“The US will take a longer time because the pathway is not clearly yet laid out. When the pathway becomes clear in the US, we’ll approach that market.”
What kind of emerging markets are you pushing into?
Reddy said they’ve already “launched in Peru, Sri Lanka, they’ve been registered in Ukraine, and some other countries. The big markets – Mexico, Brazil – are more difficult to come into.
“Most of the emerging markets go through the tender route to bring the products in so they’re looking at the price difference and the savings for the government.”
What kind of challenges are there in biosimilar development?
“Some of the challenges we’ve seen, which aren’t really related to competition as some [companies] are backing off now, but it’s more about the innovator defense in emerging markets, which we see with increasing rigor compared to the past.
As for the US market, Reddy said, “I don’t think running [biosimilar] trials in the US will be a problem. But it’s more when we take it to the market.”
Why do you think there isn’t an established pathway in the US for biosimilars?
“It’s really the politics of that country. It’s exactly what you guys know – the lobbying that goes on there. It’s absolutely not science-based,” Reddy said.