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This year will be one of reckoning for US biosimilars: the four known submissions to the FDA’s biosimilar pathway will between them stress test all aspects of the regulatory framework. The coming months will determine how far FDA can go in support of biosimilars – and how far innovators are prepared go in defense of their portfolios.
Actelion is preparing for the patent loss on its leading PAH drug not simply with a new product, but by setting a new efficacy standard across the entire PAH community.
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