linkedin post 2013-04-18 06:06:53

BIOSIMILARS ARE INEVITABLE but several big questions remain. Firstly, the post-translation modifications which may be functionally important are likely to influence the regulatory pathway, with the possible outcome that non-identical biosimilars (oxymoron) would be NCEs. Second, due to the costs involved, they are not likely to offer the kind of price reductions seen in the small molecule generics market, where post-exclusivity periods with multiple offerings, prices may be 80% lower than the original innovator price. Experts are predicting perhaps a 30% drop for genuine biosimilars.

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