Regulation, Policy, and Litigation in Biosimilars - Episode 15
Amanda Forys, MSPH: Before we wrap up our discussion, I’m just going to take a lap around the table and see if anyone has any final comments to share. Molly?
Molly Burich, MS: I think that this has been a great discussion. I think the biosimilar pathway holds a lot of promise for the United States in terms of patient access and hopefully lowering costs. But this discussion shows the complexity and the challenges that we have ahead of us. I think that this is an area where our friends in Europe are ahead of us. They’ve had biosimilars available for the last 11 years, somewhere around 700 million patient days. We have a long way to go in terms of seeing more products hit the market and seeing the impact on spend and patient cost share. It’s an exciting time in the United States, to see a brand-new market really start to develop. So, we remain cautiously optimistic that stakeholders, physicians, patients, and policy makers will continue to see the value and support long-term and sustainable biosimilar markets. It’s an exciting time.
Amanda Forys, MSPH: Thank you, Molly. Dr. Worthing?
Angus Worthing, MD, FACR, FACP: Biologics have truly revolutionized the care of diseases like rheumatoid arthritis and other autoimmune diseases. The purpose of biosimilars is to reduce the cost, which, unfortunately, is very high right now, and improve access to these great drugs. I look at the chance that biosimilars might not realize that promise and keep that promise. For example, the distribution system and other issues that might come up in terms of confidence in prescribing if this doesn’t work out; and it reminds me of when Y2K was happening for people who were using a computer and all of the work that had to go into making sure there was this seamless transition to the new millennium. Right now, we’re doing that kind of work in biosimilars.
I’m very grateful for being on this panel and having the ability to communicate my views. I’m also grateful for all of the different stakeholders: the manufacturers that are creating these products, the government lawmakers and regulators who are approving and regulating the distribution of these products, and, ultimately, my fellow physicians and all of the patients who are learning about them, prescribing, and taking them, so that we can also have that seamless transition to a time when they’re less expensive and everybody who needs them has access to them.
Amanda Forys, MSPH: Thank you. Ha Kung?
Ha Kung Wong, JD: Biologics are definitely the future of medicine. Small molecules will always be there, based on their ability to synthesize compounds and screen for activity. But biologics are essentially untapped. It’s like science fiction. We never thought we’d get to this point. But what that means is that we’re going to see many, many, many growing pains with biologics. We’re going to see more of the growing pains with biologics than we saw with small molecules, including optimizing paths to innovation as well as protecting the innovation of IP (intellectual property).
One of the major differences between small molecules and biologics is that there’s a significant increase in unpredictability that researchers are faced with due to the complex structures of those compounds as well as the method in which they are produced. Because of this, there is a much higher barrier to entry for any research entity to develop viable patient treatments out of biologics. And this resource commitment will, in turn, increase the amount of IP obtained, particularly in light of the fact that the United States is now a first-to-file system. People are racing to the patent office to get their inventions on file, as well as to increase the amount of IP challenges in part due to the IPR (inter partes review) and PGR (post grant review) process that we talked about. More than ever, researchers will have to be vigilant about their biologics development, not only for the safety and unpredictability issues in the science, but also in the way and manner in which they seek protection for their ideas and research. It’s going to be a really interesting ride, but everybody better keep their eyes on the road because we can only guess what that road is going to look like.
Amanda Forys, MSPH: Those were really great sets of insights from 3 very different perspectives. I really appreciate all of that. Thank you all so much for your contributions to the discussion today. On behalf of our panel, we thank you for joining us and hope you found this Peer Exchange® discussion to be useful and informative.