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Follow on Google News |  "Multi-therapy Drugs: Opportunities for Generics & Biosimilars" PublishedNew Pharmaceuticals research report from Espicom Business Intelligence is now available from Fast Market Research
The logic is simple: more indications result in a larger number of potential patients and, consequently, greater revenue opportunities. Obviously this logic only works if there is unmet clinical need and efficacy is demonstrated in each indication, so the number of drugs approved for multiple indications is relatively small. But where multiple indications are approved, annual sales can be counted in billions of dollars. The trend for developing products for multiple indications has been particularly evident in biological pharmaceuticals and has resulted in multi-billion dollar sales over a number of years. The commercial costs of developing biosimilars are great. Better, then to have the possibility of multiple revenue streams. ------------------------------------------------------------ Full Report Details at - http://www.fastmr.com/ ------------------------------------------------------------ Use this new report to easily answer key business questions, such as: What is the latest position on extrapolating biosimilar approvals to other indications, and what impact could this have on the sector? How is Big Pharma's attitude changing as the biosimilar market develops? Remicade (infliximab) Which companies are known to be developing biosimilar versions of Pfizer/Takeda's Enbrel (etanercept)? How might new branded development in the multi-kinase sector affect the biosimilar development of Bayer's Nexavar (sorafenib)? What revenue generating lifecycle developments will offset the challenge of generic competition for Roche's Xeloda (capecitabine)? Assessing additional sales potential from a valuable product fit The multi-therapy drugs included in this report realised total sales in excess of US$70 billion in 2010. It is, therefore, hardly surprising that many are being targeted by generic companies for the development of either traditional bioequivalent generics, or as targets for the next wave of biosimilars. The top selling multi-therapy drug in 2010 was Enbrel (etanercept) While the top five in terms of sales in 2010 were biologicals, a number of small molecule multi-therapy drugs have established a place among the market leaders and are worthy of attention as they will not face the same regulatory obstacles of biosimilars. These include AstraZeneca's Seroquel franchise, with revenue of US$5,302 million; Otsuka/Bristol- Generic and biosimilar opportunities: With annual sales counted in billions of dollars, these blockbuster drugs are undoubtedly attractive to companies developing generics and biosimilars. Competition is often fierce for bioequivalent generics of the big sellers. Consequently, companies are likely to be vying for a relatively small slice of the market. Nonetheless, when branded sales are counted in billions of dollars, companies could still make a significant return even with generic price erosion. The market for biosimilars is inherently different to the traditional generics market. Market acceptance remains a big challenge and the take up of biosimilars in Europe to date has been relatively slow. Not only will companies need to convince healthcare providers that biosimilar drugs are as good as the originator products, they will also have to compete with the originator companies who are less likely to exit the market than if faced with a flood of bioequivalent generics. Biosimilar approval for multiple indications: One question that has yet to be fully answered with regard to multi-therapy drugs is whether biosimilar approval for one indication will automatically lead to approval for all indications associated with the reference product. In the EU - so often the leading player in biosimilar regulation - the current position seems a little vague. In November 2010, the EMA discussed extrapolation in its draft guideline on similar medicinal products containing monoclonal antibodies (MAbs: EMA/CHMP/BMWP/ The final guideline has yet to be published and a year later the subject of extrapolation remains a major topic of discussion. In the meantime, companies are hedging their bets and conducting comparative studies of their biosimilar MAbs in more than one indication. About the Author The report has been researched and written by Espicom Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include Hospital Injectable Drugs: Future Prospects for Generics and Biosimilars Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs Ophthalmology Drug Futures.About Espicom Business Intelligence Espicom Business Intelligence is a highly-regarded and established provider of business intelligence services. Founded in 1982 as MDIS Publications Ltd, the company changed its name to Espicom in 1992. Initially a publisher in a wide range of industries such as power generation and telecommunications, they now focus on the global pharmaceutical and medical device sectors. View more research from Espicom Business Intelligence at http://www.fastmr.com/ About Fast Market Research Fast Market Research is an online aggregator and distributor of market research and business information. We represent the world's top research publishers and analysts and provide quick and easy access to the best competitive intelligence available. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156. End
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