FRESENIUS KABI USA LLC

Formulary placement of generics and biosimilar biological products in Part D; issues related to access to biosimilar biological products in Medicare Part B; issues related to rebate walls.

Issues related to drug pricing; issues related to Biosimilars; issues related to competition; issues related to drug shortages; DRUG Act (HR 6283, S. 1542).

Issues related to patent policy and reform, including to address patent thickets (HR 6986, S. 3583) and Promoting and Respecting Economically Vital American Innovation Leadership Act (S. 2220, HR 4370), and Patent Eligibility Restoration Act of 2023 (S. 2140) FDA/PTO Coordination, including Interagency Patent Coordination and Improvement Act of 2023 (S.79) and Medication Affordability and Patent Integrity Act (S. 2780, HR 5429) Prescription Pricing for the People Act of 2023 (S.113); Preserve Access to Affordable Generics and Biosimilars Act (S.142); Affordable Prescriptions for Patients Act of 2023 (S.150).