Many of the top-selling drugs worldwide are biologics, and several companies are seeking to produce biosimilars to compete in these lucrative markets. Recently, a flurry of proposed legislation has threatened to drastically alter the US regulation of and policies on wide ranging topics such as drug pricing, mandatory licensing, patent thickets, and the availability of post-grant proceedings.
In session 2 of this series we focus on key factors decision makers need to be aware of when considering currently pending legislation, including:
- Key provisions of proposed legislation
- European perspectives and approaches to similar issues
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