Intas Pharma expects U.S. approval for Neulasta biosimilar this year

MUMBAI, 18 Sept. Intas Pharmaceuticals Ltd could get approval this year to launch a version of Amgen Inc's (AMGN.O) white blood cell boosting Neulasta drug in the United States, chief financial officer Jayesh Shah said. That would make it the first Indian drugmaker to secure a green light to sell a biosimilar in the United States, the world's biggest healthcare market. Until recently, the regulatory pathway for such medicines was unclear and the first biosimilar was approved there only in March.

"We're expecting the approval any time now," Shah said.

The launch of the copy of Amgen's blockbuster drug, developed with Canada's Apotex Inc, could fuel sales growth of between 20 and 25 percent over the next three years for Intas, Shah told Reuters in an interview.

Intas, among India's top 15 drugmakers by sales, is one of a handful of firms in India's $15 billion pharmaceuticals industry that are developing biosimilars. These are cheaper imitations of biological drugs that are much more difficult to develop than regular copycat medicines and command a much higher price.

For generic drugmakers that have the manufacturing capabilities to develop them, biosimilars present a lucrative opportunity. The global market for such medicines is expected to reach $14 billion by 2020, as a number of top-selling biological medicines lose patent protection.

In India, Dr Reddy's Laboratories Ltd (REDY.NS) and Biocon Ltd (BION.NS) are in the race.

Neulasta, chemically called pegfilgrastim, is Amgen's second-biggest selling drug, and brought in sales of $4.6 billion in 2014. Intas has a profit-sharing arrangement in place with Apotex, but the CFO declined to disclose details.

Intas, which has been selling biosimilars in India and several other emerging markets since 2004, is now starting to focus on the United States and Europe. It launched its first biosimilar in Europe in February, and is in the process of identifying other molecules for both regions, Shah said.

In 2016, the company plans to launch 50 new products in its largest market, India, Shah said.

Unlisted Intas notched up more than $780 million in sales in the year to March and has twice considered a market debut. It sold a 10 percent stake to Singapore state investor Temasek in November last year, putting IPO plans on the backburner.

"We don't feel the need to consider a listing for the next one to two years at least," Shah said. "When we are thinking of it, we will explore all options, including an overseas listing."


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