Biosimilars, unlike traditional generics, require a strong value proposition and patient support programs to drive payer coverage and provider uptake. Experience, resources and a keen understanding of today’s market dynamics are required to advance a promising yet complex molecule into an accessible therapy for patients. As a leader in the space, AmerisourceBergen helped manufacturers successfully bring the first wave of biosimilars to market in the U.S. with commercialization programs that ensure the support and broadest access possible for patients and providers.
In a conversation with American Pharmaceutical Review, Rick Lozano, VP of Biosimilars & Integrated Business Development at AmerisourceBergen, shares insights for manufacturers on the evolving biosimilars landscape.
Where do biosimilars stand today in the healthcare landscape?
Today, a unique category of drug is developing and the market is beginning to make room for biosimilars. Biosimilars occupy anew, hybrid space: they are intended to infuse cost-savings into the biologic drug market, similar to the savings we saw when generics first launched. The potential benefit to patients, providers and the overall industry is large. Their acceptance and broader commercialization could mean greater options for patients for many disease states and cost-savings. However, the nature of these products requires more research and development, in addition to customized, end-to-end commercialization and patient support.
Market factors, including regulatory challenges and litigation from innovators, are also affecting the pace of approvals for biosimilars in the U.S. Issues like the patent dance, reimbursement codes and the big question of interchangeability are all leading to uncertainty from stakeholders in the U.S. and potentially causing new approvals to slow.
There is no proven model for launching a biosimilar that already exists in the marketplace, and all of these factors reinforce the complexity and challenges a manufacturer faces. As such, it’s critical manufacturers look at the launch from all perspectives – provider, payer, patient and regulator. If manufacturers are not educating these key stakeholders on the issues they find most important, the full potential of biosimilars in the U.S. may not be realized.
Companies like AmerisourceBergen are able to harness expertise from many sides of the business to help innovator companies develop a successful, customized biosimilar model. For example, biosimilar manufacturers, like their innovator competitors, should invest in and provide hub services or patient support programs. Patient access to education on proper administration, management, handling and storage can help maximize outcomes. Lash Group, a part of AmerisourceBergen, works with manufacturers to develop and implement successful patient support programs.
How do strategies to bring biosimilars into the market differ from generics?
A big challenge for manufacturers is determining the life cycle of the drug they are bringing to market. As biologics and biosimilars are relatively new to the health care market, accurately predicting their life cycle or the space they occupy can be a challenge. Unlike traditional generics, manufacturing and patient support costs can affect the price of biosimilars. Therefore, manufacturers need to strategize with partners who can help plan for future competition and what the entire care continuum needs to do to adopt and support the use of biosimilars.
Once a second biosimilar enters the market, the manufacturer’s strategy will change from one of pricing to distribution. Full-line distribution offers manufacturers the ability to grant the widest possible access for their product. Today, the first biosimilar entrants for unique indications will drop the market price by 15 to 20 percent. However, experts predict that percentage will increase in the future when there are two to three competitors for the same molecule, driving the costs down by as much as 50 percent. For an innovator, pivoting to a full-line distribution model after the second entrant is in market will be difficult and could cause disruption in the market from a pricing perspective, which will ultimately not benefit any stakeholders.
Aside from distribution, patient and provider education is especially crucial for biosimilars. In time, providers and patients will build.
What do the next 5-10 years hold for biosimilars?
Despite the slowing of approvals that we’ve recently seen over the last six months there is general consensus in the industry that the global market for biosimilars will grow exponentially in the coming years, some projected that it will climb to $15 billion by 2020. In the United States, about $100 billion worth of biologics will lose patent exclusivity by 2020, creating an opportunity for more product launches and fueling competition.
As the marketplace for biosimilars in the U.S. matures, issues such as reimbursement and patient support will evolve and questions concerning interchangeability will need to be addressed. In January 2017, the FDA took a step toward more clearly defining the regulation of interchangeability. However, manufacturers will need to continue building confidence with providers to prescribe biosimilars. Reimbursement rates will need to be clearly defined, and manufacturers can work with partners to affect legislative change for coding.
What hurdles will manufacturers face in terms of these products being adopted in the clinic?
In my previous role at AmerisourceBergen, I worked closely with our community oncology partners. Community oncologists consistently provide high quality service at a lower cost than some larger health systems. So, you would think that the promise of biosimilars, as a lower cost treatment option for their patients would be met with a lot of enthusiasm. But, regardless of generic, branded, innovator or biosimilar, community oncologists are looking for specific things: confidence in the product, a sustainable pricing strategy and patient support that can all be facilitated through a trusted partner.
In my experience, community oncologists and other providers are excited about the prospect of biosimilars, yet there is still a lot of apprehension. Manufacturers must take the appropriate steps to educate providers and establish a relationship as a trusted partner.
This is a point we continue to reinforce to our manufacturer partners. Community oncologists are savvy in buy and bill, and we’ve learned that price is just as important as clinical efficacy. Community oncologists, like all health care stakeholders today, are looking to biosimilar products as one part of the solution for lowering the total cost of care while achieving the best patient outcomes.
For its part, AmerisourceBergen is creating a program specifically tailored to help drive our customers’ awareness and utilization of biosimilars. Our position in the market allows us to have meaningful relationships with providers; we take that information to manufacturers so they can learn from our experiences. Working with a partner who has already built trust in a key audience will benefit manufacturers as they bring biosimilars for oncology to market.