This summer, The Center for Biosimilars® interviewed several experts for their opinions on the current need for biosimilars and how companies are working to overcome barriers to uptake. Here are some highlights.
Biosimilars face multiple barriers to widespread use in the United States, including a lack of physician confidence and deal making between payers, pharmacy benefit managers (PBMs), and other parties. However, there are ways that companies can get around those barriers to ensure biosimilar success, according to experts interviewed by The Center for Biosimilars®.
Ryan Haumschild, PharmD, director of pharmacy at Emory Healthcare in Atlanta, Georgia, discussed an action plan that followed a survey he helped conduct that revealed many providers at Emory were hesitant to use biosimilars.
He said that the survey was the first step in solving issues relating to knowledge gaps. Emory has some of the top providers in the country, but it was still necessary to initiate a program to inform clinicians about the use of biosimilars. They were hesitant to use biosimilars, partly because of lack of familiarity, partly because they hadn’t participated in clinical trials, and partly because the FDA’s expedited approval pathway for biosimilars suggested, to them, that perhaps the approvals process wasn’t as rigorous as it could be.
Haumschild said that Emory educated providers on reimbursement opportunities that exist for biosimilars to incentivize the use of these. They also looked to Europe for examples of how biosimilars could be successfully incorporated into comprehensive cancer care.
Cheryl Larson, president and CEO of Midwest Business Group on Health, based in Chicago, Illinois, said payers and PBMs may overlook employer concerns when generating formulary lists that often favor more expensive reference biologics over biosimilars.
She explained that employers need to take steps to ensure biosimilars get added to formularies, such as negotiating with PBMs for certain contract provisions or finding a new PBM if the current PBM is not willing to take employer interests into account.
Swaminathan P. Iyer, MD, a professor of medicine in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, explained how high costs of biologics and the lack of competitive pricing prevent patients from having access to these life-saving medications.
“Finding these new medications, integrating biology, and doing clinical studies has a lot of expense attached to it. So, when these new medications come out…oftentimes, patients don't have access for one reason or another, whether it's a result of not having insurance or, if they have insurance, the insurance companies may not be in a position to approve it right away even if it's an FDA-approved label,” he said.
Although the Doha Declaration, which would allow countries to circumvent patent rights in the interest of getting vital medicines to patients, is well intentioned, Iyer said implementing this may not be the best course of action for the United States.
“I think countries like India and other Asian countries are in a much better place to implement this because they are at the receiving end. So, they're able to use the Doha Declaration and other global policies to negotiate with companies, talk to them about trying to price down a certain product, and help a larger population. It helps other countries more than [it would help] a country like the [United States],” he said.
Byoungseo Choi, head of marketing for Celltrion Healthcare, discussed ways that Celltrion is working to stand out from competitors and increase product uptake, including entering its infliximab biosimilar (Remsima) into the CATALYST trial, in which investigators are evaluating treatments for coronavirus disease 2019—related issues. Choi also discussed Celltrion’s plans to launch 1 biosimilar every year through 2030.
In addition to Remsima and its subcutaneous follow-on (Remsima SC), Celltrion is developing several other biosimilars and has plans to break into the adalimumab market, where the reference product (Humira, AbbVie) is expected to face at least 6 biosimilar competitors when patents expire in 2023.
Despite this, Celltrion plans to submit an FDA application for the biosimilar (CT-P17) and capture a share of the adalimumab market.
“It’s no doubt that AbbVie is trying to strengthen its products’ competitiveness by adopting different strategies. We plan to closely monitor the current dynamics of the market, including the new entrant strategies and market penetration strategies of our competitors,” said Choi.