Heralded as the next great chapter in pharmaceutical history, biosimilars are expected to trim healthcare costs while giving patients more access at lower prices. Adopted with open arms in the European market, the move to biosimilars in the U.S. has been a slog.
Despite hindrances such as a paucity of distribution models, litigation and legislative challenges and misperceptions about their efficacy and safety, biosimilars are poised to gain ground, and quickly. According to a 2019 IQVIA report, biosimilar share of the accessible market has been on the rise and now averages 31%.
Many brand drugs are on schedule to lose patent exclusivity over the next five years, likely generating $78 billion in savings over the same time frame and soaring to as much as $150 billion in savings by 2026.
Although first approved by the FDA in 2013, only 26 biosimilars have been given the regulatory agency’s nod and of those, only thirteen have been launched. Still, of those approvals, 18 occurred in the last two years. A sign that biosimilars have been gaining traction in the U.S.
“I’d say that it was a slow start but if we fast forward to today, we’re starting to see some momentum,” Sean McGowan, Senior Director of Biosimilars at AmerisourceBergen, said. “There’s a lot of promise in the market going forward. We feel like the FDA is putting a good blueprint together, there seems to be legislation, and there are things that are very promising that will increase competition in the biosimilars market.”
Learning from Europe
Though lagging the European markets embrace of biosimilars, McGowan believes U.S. manufacturers and AmerisourceBergen stakeholders can glean some lessons from that success.
“We seem to have some challenges but what we can really take away from the European market is which products are seeing success,” he said. “In Europe, the prices are going down and competition is growing. In the US, we are starting to gain some momentum with the recent launch of three biosimilars in the oncology platform that will increase competition and hopefully bring the price down on those products.”
There are a number of factors that will bolster a jump in market share for biosimilars as the market in the U.S. begins to take shape. A market, McGowan says, that reminds him of the introduction of generics a decade ago that included misperceptions and skepticism.
The momentum of increased market share will be influenced by the recent launch of three biosimilars and the expected launch of seven biosimilars throughout this year. Those launches would double the number of biosimilar therapies available. Many of those new biosimilars will be available across all distribution channels that include full-line and wholesale distribution, which has the potential of opening up an untapped market in the hospital and health system space.
Additionally, payers and pharmacy benefit managers continue to evolve their coverage strategies though that could be a mixed bag for manufacturers as one national payer requires that patients must show an unsuccessful outcome on a biosimilar before they can be covered on an originator product. Conversely, another national payer prefers originator products over biosimilars on its formulary. Yet, knowing who is doing what is integral to formulating an overall strategy.
Finally, the FDA released its guidance on biosimilar interchangeability that allows for biosimilars to be substituted for originator biologic therapies without requiring intervention or approval of the prescribing healthcare provider. The regulatory guidance opens the door for more development of biosimilars, access, and importantly, competition.
A unique opportunity for manufacturers
Those factors are clear signals from McGowan’s perspective that a thriving biosimilars market offers a unique opportunity for manufacturers to take on accessibility and affordability issues facing patients and providers in today’s tumultuous healthcare landscape. To seize that opportunity, manufacturers will need the right commercialization strategy coupled with the best approach to payers and providers that includes strategic support from policymakers.
The linchpins to success for manufacturers drawing up their commercialization strategies are in developing provider education and support programs that help those audiences understand the benefits of their biosimilar products; mapping out a channel strategy that guarantees their product is available where patients need them; keeping a close watch on legislative actions and ever-changing payer strategies that could impact products.
“Right now, the keys to the kingdom are the providers,” McGowan said. “They need to make sure they are connected to the manufacturer, and we have some great educational tools to do that.
“We also need to ensure that legislators are educated and move forward with legislation that will support the platform. The other part of it—manufacturers that have originators need to be educated on the market as well. They will come, they will be a value to the supply chain, they will create affordability and access, and we’re doing our part in educating them.”
Providing education for providers
Not surprisingly, physicians are a key target for education programs on biosimilars. They need to know about patient services, the hub services that are provided by their originator and that they have, at the minimum, the same services that support a patient. Additionally, physicians need to know that biosimilar products are safe, pure and effective.
“Biosimilars are expensive to make, they are not like generic drugs,” Kashyap Patel, M.D., Chief Executive Officer of Carolina Blood and Cancer Care, said. “So, my biggest request to manufacturers is that they should use every possible avenue to bring awareness to providers and also ensure that the product is covered and provide access programs for patients who are not insured. Based on those, I think physicians will be ready, open and happy to take biosimilars into their regimen.”
Patel, an oncologist, believes the success of biosimilars in Europe, which has been in the market since 2006 and has amassed more than 700 million unique doses globally without any significant incidents reported, is a good road map for the U.S.
“Safety and efficacy have already been established,” he said. “The question is how intensive education can be done in the U.S. where it could help address the overall product drug price that, in my opinion, has the potential of saving tens of billions of dollars.
“If intensive education efforts are made from the manufacturers to the wholesalers to all the providers this will be a very healthy experiment in our country to reduce drug prices and we won’t talk about drug importation or other kinds of ideas.”
To learn more about how AmerisourceBergen is embracing biosimilars check out: https://www.amerisourcebergen.com/solutions-manufacturers/biosimilars