Regulatory developments in the United States, coupled with impending patent expiry, have paved the way for the introduction of biosimilars of increasing technical complexity. In the European Union, 20 first wave biosimilars, consisting of growth hormones and relatively simple recombinant proteins, have already been approved. Of those first wave biosimilars, 30% have been outsourced to dose manufacturers, and 10% to API manufacturers.
Reasons to Buy
PharmSource’s data-rich Trend Report, Catching a Wave: How Much Will CMOs Benefit From Biosimilars, concludes that the benefit of biosimilars to the CMO industry is likely to be limited. Biopharma companies or partnerships with significant commercialization and manufacturing capacity are likely to dominate the market for biosimilars and leave the smaller, CMO-dependent companies by the wayside.
The report includes data that is valuable to CMOs and bio/pharmaceutical companies looking strategically at the outsourcing of drug manufacture. “
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