September 10th 2025
The FDA's groundbreaking decision to waive clinical efficacy studies for a monoclonal antibody biosimilar revolutionizes drug approval, reducing costs and enhancing patient access.
New Reimbursement May Level Playing Field for Biosimilars
May 21st 2018The new Bipartisan Budget Act of 2018 (to be in effect on January 2019) institute new reimbursement guidelines for biosimilars under the Medicare coverage gap discount program that remove disincentives for biosimilar uptake and level the playing field for the future market place.
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