US FDA's Yim Hopes To See European-Like Robustness For US Biosimilars Market In 10 Years
In an exclusive interview with the Pink Sheet, the now-permanent OTBB director Sarah Yim discussed her expectations for the future of the US biosimilars market, her learning experience as acting director and upcoming challenges for her office.
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The guidance states that promotion creating an impression that differences are clinically meaningful when the US FDA has said they are not could be judged misleading.
Biosimilar Information Wars: Draft Guidance Seeks To Clamp Down On Efforts To Hinder Uptake In The US
Emergence of the inter partes review process dramatically changed the patent dispute arena. The decade also brought biosimilar litigation, generic price-fixing complaints, opioid lawsuits and new government investigations and antitrust actions.