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Biopharm Development & Manufacturing price for all the drugs that it approves. Because approved biosimilars cost less than their branded counterparts, the Russian government has no choice but to purchase them and to instruct healthcare providers to use them in lieu of the more expensive branded biologics. "The Russian government is desperately trying to rein in healthcare costs, and it is regularly substituting biosimilars with questionable safety histories for branded biologics," warned Ivanoff. Biocad is the major biosimilar manufacturer in Russia and currently sells biosimilar versions of EPO, G-CSF, and interferon-beta-1a as a multiple sclerosis treatment. The company is also developing biosimilar versions of rituximab (Rituxan), bevacizumab (Avastin), and trastuzumab (Herceptin). Several of these products are in late-stage clinical development. Despite the relative immaturity of the Russian biosimilar industry, Russia is poised for expansive growth in this area. Adoption of clearly defined regulatory guidelines for approval of biosimilars in Russia will help to better define future opportunities for these molecules. However, according to Ivanoff, the U.S. and European biosimilar markets are not a priority for most Russian biosimilar manufacturers. "Generally speaking, we are focused in the short term on Russia's market with Southeast Asia and Latin America as midterm goals," he said. INDIA India has the world's second-largest population, and the size of its pharmaceutical market ($14.3 billion in 2012) is growing at an annual rate of roughly 15%. Historically, India has been the world's leading provider of APIs and generic small-molecule drugs. Over the past decade or more, Indian drug manufacturers have turned their attention toward development of biosimilar products. Interestingly, until June 2012, the Indian government had not crafted a formal regulatory approval pathway for biosimilar drugs. Yet, despite this, there are currently more than 50 biosimilar products on the Indian market, including biosimilar versions of EPO (55 brands), interferons (10 brands), G-CSF, insulin, and two mAbs: Reditux (rituximab, Dr. Reddy's Laboratory) and Biomab (nimotuzumab, Biocon). At present, there are as many as 27 biosimilar manufacturers in India. However, according to Kiran Mazumdar-Shaw, chairman and CEO of Biocon, India's largest biotechnology company, most Indian companies are more interested in competing for a share of India's domestic biosimilar market rather than competing globally. "India's biosimilar industry has taken off in recent years, and opportunities in the domestic market are better than in the U.S. where regulatory confusion and high development costs plague the American biosimilar market," offered Mazumdar-Shaw. One of the major challenges facing the Indian biosimilar industry is ongoing questions surrounding product quality and safety. Nevertheless, Mazumdar-Shaw believes that the safety and efficacy concerns raised about Indian biosimilar products are more of a "perception issue" fueled by innovator companies and their stakeholders rather than a real issue. But, Mazumdar-Shaw conceded that as a biosimilar company from an emerging market Biocon needs to build its 30 LifeScienceLeader.com July 2013 credibility by developing its biosimilar products according to U.S. and European regulatory guidelines. She said, "It may cost us more but it will clearly show that biosimilar products produced by Biocon offer patients the same quality, purity, potency, and safety as those manufactured by Western companies." CHINA China has the world's largest population, and its pharmaceutical and biotechnology industries continue to expand despite the country's recent economic slowdown. Healthcare in China is nationalized, and the growing demand for high-priced biologic drug treatments is forcing China's central government to explore ways to cut annual biologics expenditures. According to Steven Lee, CEO of BioGENEXUS, an Asian biosimilar intelligence firm, "Several years ago, China's central government mandated essential healthcare coverage for all of its citizens, which implies controlled-medicine pricing and expenditures by using biosimilars and other generic drugs." To that point, industry analysts expect the size of the Chinese biosimilar markets to reach $2 billion by 2015, which could represent as much as 20% of the global biosimilar market. To date, China does not have a regulatory framework in place for approval of biosimilar products (although it is expected by the end of 2014). Biosimilars can be approved in China using its traditional biologics approval pathways, which can take many years because of the Chinese regulatory bureaucracy. Recent reports suggest that there may be as many as 18 different biosimilar versions of EPO, 16 versions of G-CSF, 15 versions of interferon alfa, and more than 8 biosimilar versions of human growth hormone that are currently commercially available in China. H. Fai Poon, R&D; Director of Hisun Pharmaceuticals China, estimates that there are over 60 different companies vying for a share of the domestic Chinese biosimilar market. Some of the key players include 3SBio, Shanghai Celgen Bio-Pharmaceutical, Shanghai CP Goujian Pharmaceutical Company (the largest and most advanced), Beijing Four-Rings Pharmaceutical Co., and Xiamen Amoytop Biotech. Most of these companies are trying to develop biosimilar versions of blockbuster mAbs including Humira, Enbrel, Remicade, and several others. For now, most Chinese biosimilar manufacturers are content to focus on China's domestic biosimilar markets rather than compete globally. "Many companies do not think beyond their local markets," offered Hisun. Consequently he added that "Chinese biosimilar manufacturers that are thinking globally may have a strategic advantage over their Chinese competitors and emerge as a winner in China's domestic market." However, like India, lingering questions regarding the quality and safety of biosimilars manufactured in China will likely impede the ability of Chinese biosimilar developers to export their products and compete on the global biosimilar market. SOUTH KOREA In 2009, South Korea created and implemented a regulatory approval framework for approval of biosimilars. Shortly thereafter, the South