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Why India is not on the Biosimilars' Radar?
Over the last 15 years, Indian Pharmaceutical Industry from having less than 5 percent market share in the US generic market, now has more than 25 percent. But we are yet to see the same advancements in biosimilars.
The major bottle-neck for developing biosimilar molecules in India lies in the regulatory challenges, says Dr Sunit Maity, AVP, product development, Theramyt Novobiologics.
He added, "Currently BioPharma companies which are developing biosimilars, must receive approval from multiple government agencies, significantly increasing the overall time it will take to bring the product to market. A single-window agency and streamlined approval process will reduce the complexity and encourage the players to develop the biosimilar molecule."
Cost and complexity of developing biosimilars poses another challenge. "Biosimilars are large and complex molecules compared to generic pharmaceuticals. Therefore, development and manufacturing of biosimilars is capital intensive and the overall commercialization timelines are 5-7 years, even for launch in domestic market, said Mr KV Subramaniam, president, Reliance Life Sciences.
He further added, "Very few generic pharmaceutical companies have capabilities and competencies in R&D and manufacturing of biosimilars."
Dr Murtaza Khorakiwala, managing director, Wockhardt provides another view, "The Biosimilar Industry even in the regulated markets is still in a nascent infancy stage and accounts for less than 5% of total Biotechnology Market. However, there are at least 8-10 corporates from India that have significant progress in developing and launching biosimilars in India and emerging markets."