Key Takeaways
- Adalimumab Biosimilars and PBM Reform: With 10 newly launched adalimumab biosimilars, there is hope for reform in pharmacy benefit manager (PBM) practices to facilitate wider adoption of biosimilars.
- Implementation of Drug Price Negotiations: The implementation of drug price negotiations under the Inflation Reduction Act is a significant development shaping 2024 to be another significant year for biosimilars.
- Awareness and Streamlined Development: Reed emphasized the importance of spreading awareness about how PBM practices impact access to medicines. Additionally, there is hope for a more streamlined biosimilar development pipeline to reduce time and costs associated with biosimilar development.
Between 10 newly launched adalimumab biosimilars, hope for pharmacy benefit manager (PBM) reform, and the implementation of drug price negotiations under the Inflation Reduction Act (IRA), 2024 is shaping up to be another big year for biosimilars, according to Julie Reed, executive director of the Biosimilars Forum.
Reed presented at the Festival of Biologics USA in in San Diego, California. Her session covered exciting developments and ongoing challenges facing the US biosimilar market and highlighted how successes from 2023 will shape the current year.
“Every one of us has a responsibility not to be reactive, but to be proactive. And I really, really want to emphasize that because as an industry, we can't sit back and hope that it changes,” Reed said.
Reed began with an overview of the major events occurring in 2024 that will affect biosimilars, including that the US missed out on $6 billion in 1 year by not using biosimilars more widely. She also emphasized that Congress has been paying attention and is looking to address ongoing challenges regarding PBM practices and how they often block access to biosimilars.
Although 2023 brought 9 adalimumab biosimilars to the market and another has launched since the start of 2024, market uptake of these products has been slow, only achieving about 2% of the market. Reed said this is because large payers and PBMs have continued to favor the reference product Humira, further displaying that reform is needed to propel biosimilars forward.
Reed emphasized the importance of spreading awareness about how these practices are impacting access to medicines. “I have a call to action to all of you. Don't talk to yourself or your buddies at work. Talk to everybody. Talk to your mom, your dad, your aunts, your uncles. Talk to everyone who needs to be concerned about this…. Again, this is a year of action. We have a decade of experience [with biosimilars]. We have an opportunity to move things forward and we're going to do it as an industry.”
The IRA has been a particular topic of interest. Although the provision does allow for increased reimbursement for biosimilars, it also forces some companies to negotiate with CMS on price. The list of the first 10 products chosen by CMS was supposed to include products not at risk of biosimilar competition; however, Stelara (ustekinumab) and Enbrel (etanercept) both have FDA-approved biosimilars awaiting market entry. These negotiated prices are set to go into effect September 2024.
As a result, the companies behind Stelara and Enbrel will be guaranteed coverage under Medicare at a special price, which will likely have an impact om coverage option for biosimilar competitors when they eventually come to market. Reed expressed that this rule may not be the death sentence for biosimilars like some experts have made it seem.
“In the past year, we've heard people say [the IRA] is terrible for the industry. I'm not quite so sure because all we're hearing is innovators saying, ‘We'd rather compete against a biosimilar than have a price negotiation.’ I think that special rule is going to change the way [intellectual property lawsuits] are handled and it's going to change the way that innovators settle on patents in order to get the biosimilar on the market, so they do not have to negotiate. We've also seen a number of employers demanding access to biosimilars… They are all telling their stories about how they have been told they cannot have access to a lower-cost biosimilar and they are storming the Hill about this,” Reed explained.
Another big topic of discussion was the hope for a more streamlined biosimilar development pipeline. There’s been a lot of talk throughout the industry of reducing the need for redundant clinical efficacy testing, which could significantly reduce the time and money it takes to develop a biosimilar, making biosimilar development more attractive to companies. Currently, biosimilars take 6 to 9 years and cost between $100 million and $300 million to develop, and FDA review can take 12 months or longer.
“We know what we're doing. The science has evolved…. So there's no need to underestimate that this can change and that we can do more to make this process more efficient, to lower the costs and time to develop a biosimilar, and at the same time, maintain the highest quality and safety and efficacy. As the biosimilar science evolves, so does the regulatory process and we will be driving for that.”
Reed ended her talk with how lawmakers and employers feel about PBM interference, showing increasing frustration and a willingness to make changes. She said she was grateful that President Joe Biden called out biosimilars by name in his State of the Union address, but it was only a first step.
Reed concluded, “We clearly have the support and acknowledgement of the right policymakers to make change happen. I do believe that will happened…. We've never stopped getting out there and trying to drive this change…. We've been around here. We're pioneers from the beginning, creating this incredibly new industry that will succeed.”
Reference
Reed J. Biosimilars in 2024: The year of action. Presented at: Festival of Biologics USA; April 15-16, 2024; San Diego, CA.
