In 2014, Germany had the highest use of biosimilars in Europe, with around 50% volume uptake. Yet data found that German patients have shown some reluctance to accept biosimilars.
The European Medicines Agency (EMA) approved marketing of 2 infliximab biosimilars (Inflectra and Remsima) in 2013, and both products were launched in major European markets, including Germany, in February 2015. By 2014, Germany was said to be leading the way in its fast uptake of biosimilars and had the highest use of biosimilars in Europe, with around 50% volume uptake.
Germany prevents pharmacists from automatically substituting originators with biosimilars, but the nation does have recommended biosimilar prescribing quotas. Despite these quotas, only a quarter of German rheumatologists said they felt pressure from healthcare authorities to switch patients to biosimilar therapies, and less than a third were aware that the 2 licensed infliximab biosimilars were approved for all indications of the originator.
In 2017, prescriptions for biosimilars account for fewer than 10% of total biologic therapy prescriptions in Germany, and more than 95% of rheumatologists would choose to prescribe the originator over its biosimilar as the first- or second-line therapy if they were unrestricted, according to a recent German study published in Patient Preference and Adherence.
What motivates rheumatologists to prescribe infliximab biosimilars, and do their preferences match actual prescribing of infliximab biosimilars? What is the level of understanding and acceptance among rheumatology patients for treatment with infliximab originators versus biosimilars of infliximab? John Waller, PhD, and colleagues sought answers to these questions, asking rheumatologists and their patients with rheumatoid arthritis (RA), ankylosing spondyloarthritis (AS), or psoriatic arthritis (PA), questions about their attitudes toward, and practices related to, innovator and biosimilar infliximab. The study was funded by Merck.
The study was conducted between December 2015 and March 2016, using the Adelphi Real World Disease Specific Programmes methodology, which seeks to provide real-world data from clinical practice in chronic disease management. Fifty rheumatologists and 261 of their patients participated in the study. The physicians provided data on their prescribing behavior and attitudes toward biosimilars via an online survey, and recruited the next 8 consecutive consulting patients, aged 18 and over, with a confirmed diagnosis of RA (n = 133), AS (n= 63), or PA (n = 65), who were being treated with an originator or a biosimilar. Patients were invited to complete online forms containing detailed questions on demographics, current conditions, level of satisfaction with current treatment, and perspectives and opinions on using biologic therapies, including originators and biosimilars.
Based on prescribing behavior and attitudes towards biosimilars, physicians were divided into 3 groups:
Patients were divided into 4 groups:
The data found that patients showed some reluctance to accept biosimilars, and a small proportion of patients were unhappy when switched to a biosimilar. Satisfaction with treatment was highest in patients who started treatment with an originator prior to biosimilar availability. Patients’ concerns with starting treatment with an originator or biosimilar included the following:
When asked about their preferences for prescribing (assuming unrestricted circumstances), more than 95% of rheumatologists said that they would prefer to prescribe an originator to a biosimilar as either the first-line therapy or the second-line therapy. This number decreased to 80% to 92% when considering third-line therapy. Further, cost and desire for experience were key factors driving physicians to prescribe biosimilars.
The researchers conclude that patients’ reluctance to accept biosimilars shows a need for patient education, especially for those who are unsure about biosimilars—education would allow patient engagement in decision making. Their reluctance also highlights the importance of patient and physician communication. “There remains a need for further research into nonclinical switching and the long-term impact of prescribing biosimilars,” the authors said.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.