India’s third-largest drugmaker by sales, Lupin, has diversified into biosimilars — cheaper versions of expensive biotech drugs — in a bid to stimulate growth amid a slowdown in recent years. Lupin plans to supplement its traditional business in generics and specialty drugs with biosimilars slated for launch in Japan, Europe and other markets by the end of the year, Lupin Biotech President Cyrus Karkaria told the Nikkei Asian Review.
The market for biosimilars is now dominated by bigger players, such as Switzerland-based Novartis and American groups Amgen and Pfizer, as well as South Korea’s Celltrion. The entry of a major Indian drugmaker will heat up competition.
More than 100 Indian biopharmaceutical companies are engaged in the manufacturing and marketing of biosimilars, consultancy Frost & Sullivan estimates.
Lupin suffered another setback in December when the FDA raised concerns about its Mandideep facility in the Indian state of Madhya Pradesh. The plant is now subject to regulatory or administrative action, and the FDA may withhold approval of any pending applications that list the facility. The company announced on May 15 that net profit after exceptional items increased to 6 billion rupees ($85.4 million) for the year ended in March, but that was only one-fourth the level of two years ago.
HDFC Securities analyst Amey Chalke feels that while a number of Indian companies have a head start in biosimilars, Lupin took a different route: first establishing itself in the U.S. with legacy products as regulators sorted out rules for the relatively new biotech sector. “What [Lupin] is also trying to do now is to build niche products that have fewer potential competitors,” Chalke said.