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Barriers to access to biosimilars Posted 13/10/2017

Barriers to the use of biosimilars include healthcare professional and patient opinions. But national and local guidelines, levels of funding and differing approaches to healthcare management can also influence access to biosimilars in different Member States of the European Union (EU), according to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway [1].

Prescriber and patient opinions
According to authors Uhlig and Goll, ‘in order for biosimilars to be adopted widely, both prescribers and patients need to be fully aware of their attributes and benefits to be confident in their use’. They point to a survey of members of the European Crohn’s and Colitis Organization (ECCO), which ‘indicated high levels of awareness for biosimilar attributes’ and recommended support for switching from reference infliximab to biosimilar infliximab [2]. However, the authors also point out that ‘only 24% agreed with extrapolation of use to indications without direct clinical evidence, and 61% stated that they had little or no confidence in using biosimilars in their clinical practice’. These opinions are in line with a previous ECCO survey that highlighted a lack of confidence in biosimilars and the need for more education [3].

Similar sentiments were also expressed in a more recent survey of US and European physicians, where biosimilar awareness was again found to be high, and although 47% of respondents ‘felt these agents were sufficiently safe and effective for them to prescribe, 43% said that they required more information on biosimilars’.

Similarly, patients’ surveys have also found ‘gaps in knowledge’ and the need for education on biosimilars.

The authors therefore conclude that ‘overall, the need for patient and physician education and for effective communication between physician and patient are issues that need to be addressed in order for biosimilars to be integrated effectively into clinical practice’.

Local and national policies
Despite the fact that Europe accounts for 80% of global spending on biosimilars, access to biosimilars varies considerably across Europe [4]. These differences can be somewhat attributed to different national and local guidelines, levels of funding and approaches to healthcare management.

Data from a study of 46 European countries published in 2015 showed wide variations in access to biologicals, with 22% not reimbursing for a biological for rheumatoid arthritis at all [5]. The study also estimated that, in total, 320 million people with rheumatoid arthritis in Europe (~40%) would have severe restrictions on their access to biologicals. The authors also noted that non-EU Member States tended to have eligibility criteria for access to biologicals that were more stringent than recommendations from the European League Against Rheumatism (EULAR). Use of biosimilars could, according to Uhlig and Goll, ‘enable many more patients to receive treatment’. They concluded that ‘Changes to European prescribing practices and regulations are necessary to take advantage of the potential benefits of biosimilar products and to harmonize treatment within EU Member States’. 

Conflict of interest
The authors of the research paper [1] reported conflicts of interest, including having received consulting fees, honoraria and having served as a consultant for pharmaceutical companies including AbbVie, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Orion Pharma, Pfizer, Roche and UCB.

For full details of the authors’ conflict of interest, see the research paper [1].

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References
1. Uhlig T, Goll GL. Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons. Rheumatology (Oxford). 2017;56(Suppl_4):iv49-iv62.
2. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. ECCO position statement on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from: www.gabionline.net/Biosimilars/General/ECCO-position-statement-on-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. European uptake of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from: www.gabionline.net/Reports/European-uptake-of-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Inequality in Europe over access to biologicals for arthritis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 13]. Available from: www.gabionline.net/Reports/Inequality-in-Europe-over-access-to-biologicals-for-arthritis

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