Antitrust Lawyer Blog
On Friday, September 14th, a Congressional briefing was held regarding the renegotiation of NAFTA and how certain changes under discussion could end up undermining the President’s Blueprint to lower drug prices in the United States by extending pharma monopolies. One of the provisions under discussion would increase brand-name drug exclusivity. Imposing additional brand-name drug exclusivity only keeps already high brand drug prices out of reach for patients for longer.
The panelists included representatives from Association for Accessible Medicines (Jeff Francer), Mylan (Marcie McClintic Coates), Patients for Affordable Drugs (David Mitchell), and AARP (Leigh Purvis). Watch the briefing here: https://www.youtube.com/watch?v=9K3RQHB-oTE
They explained how one of most promising areas of drug research is the creation of generic biologic medicines, or biosimilars. These drugs have great potential and often offer the best treatments for serious diseases such as cancer, multiple sclerosis, rheumatoid arthritis, and others. Yet, today, there are only four biosimilars on the market in the United States.
What exactly are biologic medicines and biosimilars? Biologics are medicines extracted from a variety of natural sources–from humans, animals, or microorganisms. They include a great number of products such as vaccines, blood components, gene therapy, tissues, and recombinant therapeutic proteins. Biologics are fast becoming the future of pharmaceuticals. Biologics make up 40% of drug spending in the United States and 70% of all drug price increases from 2010-2015. This statistic demonstrates the growing importance of biologics and just how expensive they are. Indeed, biologics are the cutting edge of current research, but they are often costly, sometimes as much as thousands of dollars per treatment. That renders them unaffordable even for those with comprehensive health insurance.
Enter biosimilars–biologic medicines that are approved by on data showing they are very similar to existing brand name biologics (called the reference products). Companies that make biosimilars must prove that their new drugs are just as safe and effective as the reference products. Some biosimilars can be designated as interchangeable with the reference products, which means they can be substituted for the brand name biologics. And since biosimilars rely on information from the original drugs and don’t have to go through expensive new clinical trials, they are far less expensive than the original brand biologics.
The President’s Blueprint to lower prescription drug prices underscores the importance of expediting competition for generic and biosimilars to increase patient’s access to more affordable drugs. The renegotiation of NAFTA, however, threatens to create new barriers and delay biosimilars from entering and competing in the United States. Today, the United States has a 12-year market exclusivity period for brand name biologics, during which a biosimilar cannot be approved. A biosimilar cannot be filed within the first four of those years. The U.S. Federal Trade Commission has even found that exclusivity for biologics is unnecessary because biologics continue to keep most of their market share and price even after patent expiration. Thus, there has been a push to reduce the exclusivity period in the United States so that patients could gain access to these important drugs sooner. But, it has come to light that the renegotiation of NAFTA could very well create a situation that continues to delay generic and biosimilar access and may even alter companies’ decisions to pursue biosimilar markets altogether. USTR recently announced an agreement with Mexico that would provide 10 years of data protection for biologics and an expanded scope of products eligible for protection. The panelists claimed that the international trade agreement would set a floor in the United States. The key to lowering drug prices for patients is by increasing competition through more access to safe, affordable generics, and biosimilars in the United States and around the world. An international trade agreement with a 10 year exclusivity period would limit Congress’ ability to increase competition and reduce the costs of biologic drugs in the future.
Congress must vote to approve a revised NAFTA. Contact lawmakers now to oppose the inclusion of monopoly protections for brand-name drugs that keep prices for patients higher for longer and delays competition from more affordable generics and biosimilars.
Click on the link to take action. https://p2a.co/5bmfkK5
Andre Barlow