New MGA Paper Identifies Steps to Reducing Barriers to Biosimilars

In a new paper, MGA discusses why the biosimilars market in the United States is not more developed and what steps can be taken to boost competition for biologic drugs. The paper identifies barriers to biosimilars by four categories, related to reference product manufacturers, biosimilar manufacturers, policy, and stakeholder education and awareness. Among the strategies to overcoming barriers are more physician and patient education, competitive biosimilar pricing, action by employer-sponsored health plans and private payors to encourage biosimilar utilization, and continued FDA efforts to support the budding market.

New MGA Study Estimates Lost Savings from Misuse of REMS and Restricted Access Programs

A new study from MGA examines the practice by brand drug manufacturers of using Risk Evaluation and Mitigation Strategies (REMS) and other forms of restricted access to keep generic manufacturers from obtaining samples needed to develop generic drugs. MGA estimates that this misuse blocks $13.4 billion in generic savings annually, an estimate that has grown nearly 250 percent since MGA’s 2014 analysis of this issue.