Filgrastim (Amgen)

Mumbai: The US Food and Drug Administration's (FDA) latest draft guidelines aimed at making it faster and less costly to develop biosimilars-lower-priced close copies of complex biologic drugs-could be a big boost for Indian biotech companies , top industry officials said. Companies such as Biocon , Dr Reddy's Laboratories and Intas, which are invested heavily in biosimilars , stand to gain significantly from the US move to reduce the number of human clinical studies required for approval of certain biosimilars, primarily to lower drug prices for Americans. "This progressive move will enable faster go-to-market for high-quality, affordable biologic therapies for patients battling cancer, diabetes and other chronic conditions," Shreehas Tambe, managing director of Biocon Biologics, told ET. "This will also reduce development costs for biosimilars." The USFDA's new draft guidance eliminates the need for most comparative efficacy trials-the costliest and slowest step in biosimilar development. Instead, it will allow developers to rely on advanced analytical and functional testing to demonstrate similarity with reference biologics. The agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, helping patients and pharmacists choose lower-cost options more easily. Experts estimate the move to reduce overall development timeline to half from current 5-7 years and significant reduction in cost due to removal of comparative efficacy study, which costs around $20-$25 million. "The latest FDA action is a big positive for the industry," Umang Vohra, managing director of Cipla , said. "The fact that you don't anymore need to spend the $40-$90 million depending on the product that you are coming out with to get an approvable package clearly improves your timeline to success, but also reduces the burden the company will have to go through to prove similarity." Cipla is expanding its biosimilar portfolio after it introduced its first biosimilar filgrastim in the US market in the second quarter. "We have a focused blueprint for biosimilars," Vohra said over an earnings call. Sudarshan Jain, secretary general of industry body Indian Pharmaceutical Alliance (IPA), said, "It is a welcome step as far as the US healthcare system is concerned. From the patient point of view, it is a big thing as it will lead to an increase in access to affordable medicine." At the same time, the move will lead to India playing a larger role in the biosimilar space going forward, he said. "The action presents a very positive opportunity for Indian companies. With about 130 biosimilars approved in India and some of them playing important role in the biosimilar space, Indian companies will stand to significantly benefit from the reduced timeline, which could be potentially halved from the current biosimilar project timeline of 5-7 years to about 3-4 years," Jain said. Also, with many products going off patent in the next 5-7 years, Indian companies in the biosimilar space will stand to gain, he added. Over the past decade, Indian companies have launched more than 130 biosimilars domestically, but only a handful have reached major regulated markets. Some experts are of view that this could lead to more Indian pharma majors wanting to tap the $100-billion US biologics market. Many companies have not yet entered the space due to the high cost of a biosimilar project. "There could be new entrants into the market who were avoiding due to high-cost and uncertainties," said Vishal Manchanda, pharma analyst at brokerage Systematix Group. By Rica Bhattacharyya ,