Created a balanced pathway for approval of biosimilar medicines
One of the world’s largest pharmaceutical companies wanted Congress to create a new pathway at FDA for the approval of biosimilar biological products that balanced the need to promote innovation with the need to make these treatments more accessible to patients.
- Developed an aggressive strategy designed to revitalize efforts to introduce legislation that had stalled in Congress. Strategy included a tailored education campaign for a core group of bipartisan lawmakers that explained the feasibility, safety and efficacy of biosimilars, and the potential cost savings to patients, health plans and the federal government. In addition to promoting generic competition, the campaign addressed the importance of giving innovators sufficient market exclusivity for their products in order to ensure a fair return on their investment and encourage continued drug innovation.
- Legislation was passed that not only created a new pathway for the approval of biosimilars, but also provided innovators with up to 12 years of patent protection.