Additional interchangeability studies will not be sufficient to solidify arguments for using copycats of biologics, or so-called biosimilars, instead of the original products in the US, experts said. The heterogeneity of how states interpret federal regulations on biosimilars as well as the lack of understanding of biosimilars among patients, physicians and payers ultimately stand in the way of biosimilar success.
The Biologics Price Competition and Innovation Act, which passed with the Patient Protection and Affordable Care Act signed into law in 2010, provided an expedited biosimilars approval pathway and guidance on litigation. Biosimilars are to biologic drugs what generics are to traditional pharmaceutical drugs, with a slight difference; i.e., less expensive but distinct compounds that have similar pharmacological effects to the original.
Yet, unlike generics and small molecules, biosimilars need to first establish their interchangeability through studies for pharmacists to be able to swap out an originator biologic prescription with its biosimilar, and no biosimilars have established that yet. This lack of interchangeability has reportedly impeded market traction.
Ever since the FDA published its guidance for the need for biosimilar interchangeability studies in January 2017, impressions have built up that establishing interchangeability plays a key part in uptake, said Cate Lockhart, program director, Biologics & Biosimilars Collective Intelligence Consortium (BBCIC), Alexandria, Virginia, speaking on the sidelines of last month’s meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). While research organizations such as the BBCIC — which presented developments in postmarket biosimilar and biologics research at an ISPOR panel — can help biosimilar companies become better equipped to ascertain interchangeability, uptake may still remain lacklustre unless legal infrastructures across different states are streamlined and weak physician and patient education is improved, she noted.
Despite there being 11 biosimilars approved in the US, only three have been launched so far, said Mark Cziraky, vice president of research, Healthcore, Wilmington, Delaware, during a panel. Launched biosimilars are: Zarxio (filgrastim-dyyb) from Novartis’ subsidiary Sandoz, which was in March 2015 became the first approved biosimilar, Pfizer and Celltrion’s Inflectra (infliximab-dyyb) and Merck and Samsung Bioepis’ Renflexis (infliximab-abda). Eight other biosimilars including Sandoz’s Erelzi (etanercept-szzs), approved in August 2016, have been approved but some do not have definite launch dates yet or have been delayed due to legal wrangles.
Legal complications to uptake
Biosimilars’ legal snarls have to be addressed for uptake success in the US, said Nicolas Arkells, CEO, and Avijeet Chopra, chief scientific officer, Manticore Consulting Group, Scottsdale, Arizona. As individual states can have varying interpretations on biosimilar adoption, uptake might be limited due to market uncertainty in each state, Chopra added.
As of May, about 41 states have some sort of state-level regulation regarding biosimilars and they might not be applicable across state or regional circuit lines, creating market uncertainty for manufacturers, Arkells said. While some lower courts seem to have shown favourable attitudes towards biosimilars, the current Supreme Court’s federalist tendencies — especially with the recent appointment of Supreme Court judge Neil Gorsuch — would ultimately let state interpretations of federal rules stand, making certain states less favourable for uptake, he noted.
Some states such as New York have rules that require pharmacists to adopt a less expensive biosimilar if available by default, but other states have regulations that complicate biosimilar use, Arkells said. These could include provisions to inform providers and patients on the intention to change prescriptions, with some states requiring explicit patient consent.
While patient consent in itself is not a detriment to uptake, the lack of patient or even physician understanding of biosimilars could lead to misinformed decisions not to switch, Arkells said. For example, in states with legal language that require patient consent, patients subject to advertising messages from branded drugs or misinformed by word of mouth about the efficacy or safety of biosimilars could result in greater rejections of biosimilars, Chopra noted.
States need to learn from each other, but there is little push to do so if local lawmakers are ignorant on the issues behind biosimilar adoption, Arkells said. Many state lawmakers are unaware that their local laws contain language that could prevent cost-savings from adopting biosimilars, such as imprecise language on interchangeability.
With the lack of movement to harmonise legal frameworks between states, combined with the FDA currently focused on pushing biosimilar approvals through, pharmaceutical companies will have to take on the burden to approach state lawmakers and educate them about the changes needed to promote biosimilar uptake, Arkells and Chopra said.
Better education needed
Meanwhile, the general lack of enthusiasm, awareness and understanding on biosimilars among many physicians could dampen the outlook for competition, said Dipen Patel, executive director, Pharmerit International, Bethesda, Maryland. A 2015 American Gastroenterological Association survey found that 78% of gastroenterologists were very concerned about biosimilars’ safety and immunogenicity, despite convincing clinical trial data, Cziraky said in the panel.
Inflectra’s 2017 sales were $419m, with expected peak sales of $1bn in 2024. Renflexis, launched in 2017, has expected peak sales of $1.5bn in 2024. Novartis has not disclosed Zarxio’s sales.
Manufacturers have ramped up outreach to physicians, as real-world evidence of biosimilars increases, and awareness seems to be on the rise but is still a far cry from where it should be compared to Europe, Patel and Lockhart said. Physicians want to see more US-derived data, given that biosimilars in the US are still nascent, and a bulk of evidence of switching to biosimilars has been European-focused, Patel said.
Payers play a crucial role in biosimilar success too, Patel said. From his experience with payers, those who have existing contracts with biologic companies and have balanced their near-term budgets find little incentive to reexamine their coverage to switch to biosimilars, he noted. While biosimilars’ current potential seems to capture only new patients, payers need to be convinced that they have the power to move the uptake needle beyond status quo to realize the long-term financial benefits of covering biosimilars, Patel said.
Attitudes towards biosimilars are gradually warming, and many consultants, manufacturers and research organizations raise the question on how to generate better data for payers to consider biosimilars more, but perhaps what is needed for greater awareness is also time, Lockhart said. It might take about five years before biosimilars become really embraced in the US, but the FDA has shown a strong commitment to expanding the presence of biosimilars, which physicians and payers are taking into consideration, Patel noted.
Shuan Sim is a reporter for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.