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.

Happy Birthday, FDA Tobacco Plan!

Just over a year ago, the Food and Drug Administration (FDA) announced a bold new plan to reduce nicotine in cigarettes to non-addictive levels and encourage the development of non-combustible nicotine products. Key to the FDA’s approach is an acknowledgement of both the continuum of risks associated with various nicotine delivery mechanisms and the opportunity for innovative products to reduce the health risks associated with tobacco consumption

MGA’s Alex Brill on CNBC’s Squawk Box

“…. There are specific issues with regards to our trade relationship with China. But not only with China, with other of our major trading partners around the world. We are better off with good intellectual property laws. We are better off with lower tariff and non-tariff barriers. We need a process that takes us from where we are forward and not backwards, of course.”

MGA’s Alex Brill on White House Chronicle

Brill said, “If we take a market-based approach, which we think is a conservative strategy to addressing climate change, we want to use price signals, and a carbon tax is a price signal. It negates the need for…the regulatory toolbox that’s currently being deployed…and allows the market to find…the most efficient way to get emissions down.”