Life Science Leader Magazine

JUL 2013

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Biopharm Development & Manufacturing be more difficult to develop but will give you a much better — recent estimates indicate that roughly 80% of prescriptions are return than just developing a simple commodity tablet — it filled with generic drugs — its popularity is growing in other marjust makes sense," said Tarriff. He added, "The more innovakets including Europe and Japan. In 2007, Mylan bought Germanytive generic companies have identified areas where they have based Merck KGaA's generics business, and in 2012 it entered into acquired the requisite expertise, built some type of barrier to a strategic partnership with Pfizer to sell generic drugs in Japan. entry (cash, infrastructure, etc.) to prevent competition, and More recently, Mylan entered into an exclusive strategic colpossess the knowledge to continue to build value over time." laboration with India-based Biocon for global development and Companies trying to capitalize on difficult-to-make commercialization of Biocon's Glargine, the generic version products include Actavis, Teva, Mylan, and Impax of Sanofi's Lantus; Lispro, the generic version of Eli Laboratories. Interestingly, Mylan and Teva Lilly's Humalog; and Aspart, the generic version are competing with one another to bring of Novo Nordisk's NovoLog. Also, last year, generic versions of GlaxoSmithKline's U.S.-based Watson Pharmaceuticals purasthma medicine Advair to market. chased the Swiss drug maker Actavis This has been difficult because Group for $5.9 billion, increasing its Advair combines two drugs that presence in overseas markets. After are inhaled through a device. the acquisition, Watson changed Likewise, Actavis is expected its name to Actavis, which is betto introduce a generic verter known internationally and is sion of Endo Pharmaceuticals' likely to provide a better global Lidoderm pain patch next reach into emerging markets like year. China, India, Brazil, and elseMost U.S. and foreign generic where. "The generic industry companies are also eyeing biois exploding in Brazil and Latin similar drugs as a new means America," said Wolf. However, to bolster revenue and sustain Generic Pharma 2.0's Cox warns, growth. Since 2004, more than "While many generic drug companies 15 biosimilar products have been are focusing on emerging markets, these approved worldwide. In general, bioopportunities often present more chalAsa Cox, chief executive and founder, similars cost 20% to 40% less than their lenges than solutions." He recommended that Generic Pharma 2.0 branded biologic counterparts. While the size companies seeking to penetrate these markets of the global biosimilar market continues to grow, should proceed with caution to gain a better underthese molecules are still not permitted to be approved or sold standing of regional and national market dynamics before making in the U.S. — the world's largest biologics market. Nevertheless, a final decision. there are currently as many as 50 generic companies, includTHE FUTURE IS INNOVATION ing, Sandoz, Mylan, Teva, Hospira, Biocon, and others, that are The generic drug industry, much like the branded pharmaceutideveloping biosimilar products. "Biosimilars appear to be the cal industry, is in transition and rapidly changing. But, as Eagle next big thing for generic drug makers," said Kai Wolf, a former Pharmaceutical's Tarriff emphasized, "The generic drug indusMerck Serono executive who helps generic drug manufacturers try is filled with extremely talented people who will continue register their products in Brazil and Latin America. However, Wolf to innovate and find ways to compete and make money. And warned, "It's not going to be as easy or lucrative as many generic I don't think that this industry is going away anytime soon." companies think." Generic Pharma 2.0's Cox agrees, "Biosimilars Cox offered a different perspective. He said, "I think generic will require a massive investment in marketing to offset a certain companies will be highly marginalized unless they can plot a fight by incumbent brands. We've seen some modest successes in path to being involved in the service-oriented, personalizedEurope, but it is clear that the generic companies have a long way treatment healthcare sector of the future. The rapid evolution to go to compete in the biosimilar space." of technology, data, and education, combined with the dynamFOCUS ON EMERGING MARKETS ics of funding, fulfillment, and regulation, will create a very Another approach being used by generic companies to gain an different drug industry compared to the one we have today." edge and sustain their growth is expanding into global emerging Nevertheless, both Tarriff and Cox agree that innovation is the markets. While generic drug use is pervasive in the United States key to the future success of the generic drug industry. "We've seen some modest successes in Europe, but it is clear that the generic companies have a long way to go to compete in the biosimilar space." July 2013 LifeScienceLeader.com 33

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