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Saturday

 
Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013 

The market for injectable generics has been through a period of consolidation over the last few years as the leading companies have increased their presence through acquisition. The major players include Hospira, Sandoz (Novartis), Hikma Pharmaceuticals, Fresenius Kabi and Teva Pharmaceutical Industries. But interest in generic injectables has not been limited to established generic companies, as pharmaceutical majors like Pfizer have also become attracted to the market.
This is hardly surprising with a global injectables market in the region of US$144 billion. While the lion's share remains with the innovative industry for the time being, the generic injectables market is worth around US$12.2 billion and numerous high value injectable products will face patent expiry in major markets over the next decade. But, many of the big sellers are biological products and biosimilar approvals will only be possible for a few companies. Gaining regulatory approval in developed markets will be far more complex for biosimilars than for chemical generics and will involve costly clinical trials. To date, only a handful of companies have gained regulatory approval for biosimilars in Europe, and the US is likely to remain elusive to all but a select few. Among these, as the only US-based company with approval for biosimilars in the EU, Hospira is well positioned to take advantage of the potential US market.
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