ORIGINAL ARTICLE Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis Council Arnon D. Cohen, MD, MPH, PhD,a,b Ronald Vender, MD, FRCPC,c Luigi Naldi, MD,d Robert E. Kalb, MD,e Tiago Torres, MD, PhD,f Murlidhar Rajagopalan, MD,g Joelle van der Walt, PhD,h Lluıs Puig, MD (Hon), PhD,i and Helen S. Young, MB ChB, PhD, FRCPj Beer-Sheva and Tel Aviv, Israel; Hamilton, Ontario, Canada; Vicenza, Italy; Buffalo, New York; Porto, Portugal; Chennai, India; Paramus, New Jersey; Barcelona, Spain; and Salford, United Kingdom Background: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. Objective: To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. Methods: A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as [80% positive opinions. From the Siaal Research Center for Family Medicine and Primary speaker at events sponsored by AbbVie, Almirall, Amgen, Arena Care, Faculty of Health Sciences, Ben-Gurion University of the Pharmaceuticals, Biocad, Boehringer Ingelheim, Bristol-Myers Negev, Beer-Shevaa and Department of Quality Measurements Squibb, Celgene, Eli Lilly, Janssen, Leo Pharma, MSD, Novartis, and Research, Clalit Health Services, Tel Aviv, Israel,b Derma- Pfizer, Samsung-Bioepis, Sandoz, and Sanofi. Dr Rajagopalan trials Research, Hamilton, Ontario, Canada,c Department of has been a speaker on biologicals for Novartis, Pfizer, and Dermatology, Ospedale san Bortolo, Vicenza, Italy,d Depart- Janssen. Dr Puig has served as a consultant and speaker and ment of Dermatology, SUNY at Buffalo School of Medicine and has received fees and honoraria from AbbVie, Almirall, Amgen, Biomedical Sciences, Buffalo, New York,e Department of Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Jans- Dermatology, Centro Hospitalar Universitario do Porto, Porto, sen, Leo Pharma, Lilly, Merck-Serono, MSD, Novartis, Pfizer, Portugal,f Department of Dermatology, Apollo Hospitals, Chen- Regeneron, Roche, and Sandoz. Dr Puig’s institution has nai, India,g PRI Healthcare Solutions, Paramus, New Jersey,h received research funding related to the treatment of psoriasis Department of Dermatology, Hospital de la Santa Creu i Sant from AbbVie, Amgen, Janssen, Lilly, Novartis, and Pfizer. Dr Pau, Universitat Aut onoma de Barcelona Medical School, Young has served as a consultant for Johnson and Johnson, Barcelona, Spain,i and Department of Dermatology, Manchester AbbVie, UCB Pharma, Leo Pharma, and Almirall; received Academic Health Science Center, Salford Royal Hospital (Hope), grants/grants pending from Leo Pharma; received payment The University of Manchester, Salford, United Kingdom.j for developing educational presentations, including service, on Funding sources: None. speakers’ bureaus from Janssen, Novartis, MEDA, Leo Pharma, Conflicts of interest: Dr Cohen received research grants from and Almirall; and received coverage or reimbursement of Janssen, Novartis, AbbVie, and Sanofi and served as a consul- travel/accommodations expenses by Novartis and Leo Pharma. tant, advisor, or speaker to AbbVie, Amgen, Boehringer Dr Walt has no conflicts of interest to declare. Ingelheim, Dexcel Pharma, Janssen, Kamedis, Lilly, Neopharm, IRB approval status: Not applicable. Novartis, Perrigo, Pfizer, Rafa, Sanofi, Sirbal, and Taro. Dr Vender Accepted for publication September 25, 2020. has served as an advisory board member and investigator, has Correspondence to: Arnon D. Cohen, MD, MPH, PhD, Siaal been on the speakers bureau, and has received honoraria from Research Center for Family Medicine and Primary Care, Novartis, AbbVie, Janssen, Lilly, UCB, Amgen, Celgene, Pfizer, Faculty of Health Sciences, Ben-Gurion University of the and Bauch Health. Dr Naldi has received consultant fees from Negev, Beer-Sheva, Israel. E-mail: ardcohen@gmail.com. AbbVie, Almirall, Boehringer Ingelheim, Bristol Meyers Squibb, 2666-3287 Celgene, Eli Lilly, Leo Foundation, Janssen-CILAG, Menarini, Ó 2020 by the American Academy of Dermatology, Inc. Published Mylan, Novartis, Pfizer, and Sanofi. Dr Kalb has received grants by Elsevier Inc. This is an open access article under the CC and/or research funding from AbbVie, Amgen, Janssen-Ortho, BY-NC-ND license (http://creativecommons.org/licenses/by-nc- and UCB; has served as a consultant for Amgen, Janssen-Ortho, nd/4.0/). Sun Pharmaceutical, and UCB; and was a member of the Data https://doi.org/10.1016/j.jdin.2020.09.006 Safety Monitoring Board for Eli Lilly and Company. Dr Torres has received honoraria for acting as a consultant and/or as a 224 JAAD INT Cohen et al 225 VOLUME 1, NUMBER 2 Results: A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include ‘‘Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so’’ and ‘‘Patients and patients’ organisations should be involved in all decision making and policy development about the use of biosimilars.’’ Conclusion: The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis. ( JAAD Int 2020;1:224-30.) Key words: biosimilars; interchangeability; International Psoriasis Council; psoriasis; switching; tumor necrosis factor inhibitors. INTRODUCTION equivalence studies of a Biologic therapies, CAPSULE SUMMARY single indication, requiring including monoclonal anti- sample sizes usually smaller bodies and receptor fusion d This study provides consensus than those for studies on the proteins targeting tumor ne- statements from the Biosimilar Working approval of new biologic crosis factor-a or interleukins, Group about biosimilar use in patients agents, are acceptable and have significantly improved with psoriasis, providing global guidance need not be repeated for the treatment outcomes for to clinicians, patients, and other every indication of the origi- patients with psoriasis.1-3 stakeholders. nator if extrapolation is Although considerably more accepted by regulatory d Switching a stable patient from a effective than traditional sys- agencies.14 Although this ac- reference product to a biosimilar temic therapies, the high cost celerates the developmental product is appropriate if the patient and of biologic agents has limited process and reduces the cost physician agree to it. their use and contributed to of biosimilar production, the inequalities in the care pro- dermatology community vided to patients with psoria- may find it difficult to inter- sis in many countries.1,4,5 pret data collected from biosimilar trials conducted One way in which healthcare systems can maxi- in dissimilar disease states.15,16 Formerly, most of the mize the value derived for patients from the money it clinical testing of antietumor necrosis factor bio- spends on biologic medicines6 and widen access to similars approved for use in psoriasis had been biologic therapies is through the use of biosimilars.7,8 performed in patients with rheumatoid arthritis. Biosimilars are drugs that are highly similar, with no The International Psoriasis Council (IPC) called for clinically meaningful differences, to originator bio- clinical studies to be conducted in patients with logic medicines, as proven by high-level clinical psoriasis, and studies have now been conducted in studies.9 The development and approval of bio- patients with psoriasis.14,17,18 similars according to the rigorous standards of By definition, biosimilars and originators have pharmaceutical quality, safety, and efficacy are still identical primary amino acid sequences. However, associated with significant costs.10 However, in com- there may be minor differences in glycosylation, parison to the developmental process for originator deamination, oxidation, or 3-dimensional structures biologics, there is significant emphasis on the phys- between biosimilars and originator biologics, which icochemical and functional characterization of bio- may affect their end-target interactions and help similars, which is considered the foundation for the determine differences in efficacy and safety.19,20 regulatory approval of biosimilars, rather than on Patients and clinicians may be concerned about a clinical testing per se.11,12 Clinical testing for regula- potential loss of efficacy, altered immunogenicity, or tory approval must be conducted in a patient unanticipated differences in adverse effects when population sensitive enough for the detection of switching to a biosimilar.21,22 differences in efficacy or safety between the bio- Dermatologists worldwide are faced with the similar and reference products.13 Noninferiority or need to choose between an originator or a biosimilar 226 Cohen et al JAAD INT DECEMBER 2020 participate in the debate. Thus, the IPC BSWG Abbreviations used: members were at liberty to express their opinions. BSWG: Biosimilar Working Group The consensus statements were reached using the IPC: International Psoriasis Council NGT: nominal group technique nominal group technique (NGT).25 NGT is a process used for solution generation, decision-making, and consensus agreement considering each participant’s opinion. The NGT exercise used in this study had 3 in biologic-na€ıve patients or to switch from an stages: 1) Identification of essential issues on the originator to a biosimilar in patients established on use of biosimilars in patients with psoriasis, 2) treatment.23 However, with significant financial in- Discussion and collapsing of the statements, and 3) centives driving the prescription of biosimilars in Prioritizing and ranking of the statements by voting. many health economies, biologic treatment deci- In the identification stage, the participants were sions may become more physician-independent in requested to submit statements about the use of the future.24 Multiple biosimilar medications now biosimilars via e-mail correspondence. These state- exist, which may result in numerous changes in ments were collected by a group facilitator, who led a therapy for individual patients, making it almost consensus-reaching meeting of the IPC councilors impossible to attribute safety signals to a specific of the BSWG. The meeting took place in February biosimilar medication.14 Interchangeability is a major 2019. During the meeting, it was possible to submit challenge for dermatologists, and traceability is additional statements. In the second stage of the NGT imperative in order to collect accurate pharmacovi- exercise, the participants discussed each idea on the gilance data on adverse events in patients with list so that the meaning of the statements was made psoriasis who have been managed with biosimilar clear to everyone. Thereafter, the statements were and originator biologic treatments.24 collapsed to 38 major statements. The IPC, a network of more than 100 experts on Twenty-three councilors of BSWG participated in psoriasis dedicated to improving psoriasis care the consensus voting of the statements on bio- around the globe, has previously urged dermatolo- similars, which were grouped into 10 different gists to actively participate in developing policies categories (in alphabetical order): biosimilar policy, for biosimilar prescription worldwide and has cost of biosimilars, education, extrapolation of indi- published reports on many aspects of biosimilar cation, interchangeability, naming, pharmacovigi- prescription.11,14,16,23,24 As clinicians continue to lance, regulatory considerations, substitution at the wrestle with the opportunities and challenges that pharmacy level, and traceability. In the voting stage, biosimilar therapeutics offer, the IPC has identified the participants were asked to express their agree- the need for clear guidance on the use of biosimilars ment on each statement using an online survey in the treatment of psoriasis. In the current report, we conducted using SurveyMonkey (https://www. describe a semiqualitative structured process em- surveymonkey.co.uk/). The degree of agreement ployed by the IPC and the consensus statements on with each statement was ranked into 5 categories: biosimilar prescription that have been agreed upon ‘‘not at all,’’ ‘‘slightly,’’ ‘‘moderately,’’ ‘‘very much,’’ by IPC councilors. and ‘‘extremely,’’ with the latter 3 implying a positive opinion. Approval of the consensus statements was MATERIALS AND METHODS predefined as [80% positive opinions in the survey. The study was conducted within the framework The study was approved for publication by the of the IPC Biosimilar Working Group (BSWG), which IPC. All 38 consensus statements were reviewed and includes IPC councilors who are interested in bio- voted upon by 100% of the participants in the survey. similars. The group conducted 1-2 meetings per year, in which the various aspects of biosimilars were RESULTS discussed. The meeting attendees included members The consensus approval was reached for 36 out of the IPC BSWG, as well as external experts and of the 38 statements (94.7%), with 100% positive pharma representatives. Pharma representatives opinions (‘‘moderately,’’ ‘‘very much,’’ and participated in the meeting to present data from their ‘‘extremely’’) in 21 (55.3%) (Table I). In approxi- respective companies. Discussions were held with mately one-third (33.8%) of the statements, the the participation of the BSWG members, guests, and ‘‘slightly’’ agreement choice was recorded. The ‘‘not pharma representatives. When sensitive matters at all’’ response was recorded in less than 1 quarter of were discussed (eg, prioritization of drug use in the statements (23.7%). The categories with 100% psoriasis), the guest scholars and pharma represen- positive opinions included cost, pharmacovigilance, tatives were asked to leave the meeting room and not and traceability. The categories with [90% positive JAAD INT Cohen et al 227 VOLUME 1, NUMBER 2 Table I. Statements About the Use of Biosimilars for the Treatment of Patients With Psoriasis Positive Statement opinions (n) % 1 Evaluation of biosimilar products must meet the rigorous standards of regulatory guidance 23 100% (EMA, FDA, WHO). 2 Biosimilar assessments, including physiochemical, pharmacokinetic, and functional analytical 23 100% assays, must meet rigorous standards. 3 In comparison to the reference product, a biosimilar product should demonstrate no clinically 23 100% meaningful differences in efficacy, safety, or immunogenicity. 4 Biosimilar trials are intended to demonstrate clinical equivalence to the reference product. Use 23 100% of the same endpoints (efficacy and safety) of the pivotal trials of the reference product is preferable. 5 Biosimilar clinical trials should include both elements of crossover and parallel design. 23 100% 6 Biosimilar clinical trial designs incorporating at least 2 switches between the reference product 22 96% and biosimilar are preferable. 7 Studies designed to examine switching between multiple biosimilars can provide relevant 22 96% information. 8 Trials of biosimilars for the indication of psoriasis should be performed in patients with 21 91% psoriasis. 9 Extrapolation of indications from trials in other diseases, as determined by the regulatory 19 83% agencies, is acceptable. 10 Published clinical trial data demonstrated that a single switch from an innovator to a biosimilar 22 96% is safe and effective. 11 Prescribing biosimilars to biologic-na€ıve patients with psoriasis is appropriate if the patient and 22 96% physician agree to do so. 12 Switching a stable patient from a reference product to a biosimilar product is appropriate if the 20 87% patient and physician agree to do so. 13 Multiple switches between various biosimilars and reference biologics is not the preferred 15 65% option but is acceptable. 14 Treatment switches should not occur in less than an adequate period of time (usually 6 months) 23 100% from initiation of the reference product, allowing full assessment of its therapeutic effect. 15 Switching between different biosimilars should be performed with caution, until more evidence 17 74% is generated supporting this practice. 16 Clinicians should be notified and should provide approval prior to any originator or biosimilar 22 96% drug substitution being made. 17 Clinicians should be given explicit authority to override any suggested substitutions. 21 91% 18 Registries, consortia, and large, prospective databases of patients treated with biosimilars 23 100% should be established. 19 Health claims data should be used to provide pharmacovigilance when using biosimilars and 23 100% reference products. 20 Traceability should be ensured so that a specific biosimilar, and/or reference product, its 23 100% producer, and its manufacturing history (eg, lot number) can be reliably identified. 21 Each biosimilar name should be easily distinguishable from its biologic reference product and 22 96% other biosimilars. 22 Using a biosimilar brand name may be a suitable option. 20 87% 23 One biosimilar name is preferable to use in every country. 22 96% 24 Patients and patients’ organizations should be involved in all decision-making and policy 22 96% development about the use of biosimilars. 25 Dermatologists and professional organizations should take an active role in the development of 23 100% biosimilar prescribing policies in their respective healthcare and governmental agencies. 26 Biosimilars should not prevent or delay access to the use of new biologic drugs. 23 100% 27 Dermatology leadership should develop guidelines for the use of biosimilars. 23 100% 28 Biosimilar resources for physicians should include summarized information on the quality of the 23 100% comparability data used to demonstrate biosimilarity for approval (PK and PD profiles, clinical trial data). 29 The impact of biosimilar education on prescribers should be measured with an emphasis on 23 100% prescriber confidence and attitudes toward clinical use of biosimilars. Continued 228 Cohen et al JAAD INT DECEMBER 2020 Table I. Cont’d Positive Statement opinions (n) % 30 Practice guidelines for biosimilars should be developed at a local level, which will differ across 20 87% countries throughout the world. 31 Translation of biosimilar information from physicians to patients is needed for clear 23 100% understanding. 32 Dermatology leadership should develop educational programs for dermatologists about the 22 96% complexity of manufacturing and use of biosimilars. 33 Biosimilar companies are advised to communicate the quality of manufacturing to 23 100% dermatologists. 34 Cost of biosimilars should be low enough to genuinely improve patients’ access to these drugs. 23 100% 35 Biosimilars are therapeutic options over their originator products if their use provides cost 23 100% savings to patients and/or reduces financial burden to healthcare system. 36 Biocopies, ’’intended copies‘‘, and/or ’’biomimic products‘‘, which are not biosimilars, should 23 100% not be used. 37 Education is needed to distinguish biosimilars from biomimics. 23 100% 38 Biomimics should not have the same name as biosimilars or originator products. 23 100% EMA, European Medicines Agency; PD, pharmacodynamics; PK, pharmacokinetics. opinions included cost, education, pharmacovigi- The patents of several key biologic therapies for lance regulatory considerations, substitution at phar- the treatment of psoriasis have either already expired macy level, and traceability. or will expire by 2020.28 This is driving interest in A consensus was reached, and all the statements biosimilar drug development by pharmaceutical were agreed upon ([80% positive opinions) in the manufacturers.28 However, biosimilar use and their following categories: biosimilar policy, cost of bio- subsequent market uptake are contingent on physi- similars, education, extrapolation of indication, cians’ confidence and willingness to prescribe bio- naming, pharmacovigilance, regulatory consider- similars in clinical practice.28 In this paper, the IPC ations, substitution at pharmacy level, and trace- provides a suite of consensus statements on the use ability. A consensus was not reached for only 2 of biosimilars for the management of psoriasis across statements, both of them in the interchangeability 10 different categories: biosimilar policy, cost of category. The statement ‘‘Multiple switches between biosimilars, education, extrapolation of indication, various biosimilars and reference biologics is not interchangeability, naming, pharmacovigilance, reg- the preferred option but is acceptable’’ received ulatory considerations, substitution of pharmacy only 65.7% positive opinions and was, therefore, level, and traceability. However, some IPC members not agreed upon. A consensus on the statement expressed concerns regarding switching of therapies ‘‘Switching between different biosimilars should be between different biosimilars and did not reach a performed with caution, until more evidence is consensus regarding multiple switches between generated supporting this practice’’ was not reached originator biologics and biosimilars. either, with only 73.9% positive opinions (28/38 The US Food and Drug Administration’s (FDA) voters). These results indicate that single or multiple designation of interchangeability means that a bio- switching between biosimilars in patients with pso- similar is expected to produce the same clinical riasis is still open to argument in the councilors’ results as the reference product when substituted at opinions. any point in therapy and to present no greater safety risk than continuous treatment using the reference DISCUSSION product; therefore, an interchangeable product may Biologic therapies have led to significant improve- be substituted without the intervention of the pre- ments in the outcomes of patients with psoriasis, scribing provider.26 Draft guidance for full inter- with the downside of increased healthcare costs.26 changeability, including automatic substitution, of a The signature promise of cost-effective biosimilars is biologic medicine, as developed by the FDA, pro- to improve patient access to highly effective treat- posed that drug manufacturers perform at least 1 ments earlier in the therapy cycle, decrease costs, randomized clinical trial comparing patients who and maintain improved health outcomes.27 This undergo multiple treatment switches (at least 3) presents an opportunity for dermatologists to deliver with those continued on the same treatment.29 In high-quality and high-value care.14,26,28 the past, many randomized trials have involved only JAAD INT Cohen et al 229 VOLUME 1, NUMBER 2 1 treatment switch.30 However, in the phase III reflects the debate that we, as experts, have been EGALITY trial with a biosimilar of etanercept, considering in recent years, including the general, GP2015, randomized patients with moderate-to- specific, and controversial aspects of biosimilar pre- severe chronic plaque psoriasis to continue on the scription for psoriasis. Second, for the statements for same treatment with the originator or were made to which a consensus was not reached, we did not undergo a sequence of 3 switches between the elucidate the areas of disagreement as this was originator and the biosimilar at 6-week intervals.31 beyond the scope of this study. Finally, our paper The study assessed the effect of the treatment does not provide a comprehensive review of the switches on efficacy, safety, and immunogenicity literature and evidence regarding biosimilars as this and showed that the triple switching had no effect has been provided by our previous papers on on the safety or efficacy of the therapy.31,32 During biosimilars.11,14,23,24 the study, 6 patients exhibited transient presence of In this paper, the IPC BSWG provides consensus low titers of non-neutralizing anti-drug antibodies (5 statements for the use of biosimilars in the treat- patients during the first 4 weeks of treatment and 1 ment of patients with psoriasis. These consensus patient at week 36).31 During the second (triple statements are intended to offer guidance to clini- switching) phase of the treatment, none of the patient cians, healthcare organizations, pharmaceutical in- participants exhibited the presence of anti-drug dustry, regulators, and patients regarding the antibodies, confirming the low immunogenic poten- development and use of biosimilars for the treat- tial of both the biosimilar and originator etanercept.31 ment of psoriasis around the world. In conclusion, Furthermore, a 51-week, double-blinded, phase the IPC endorses evidence from clinical trials and III study demonstrated the biosimilarity between increasing experience from daily clinical practice, GP2017 and the reference biologic adalimumab, which show that biosimilars are equivalent to with equivalent efficacy and similar safety and reference products in terms of quality, efficacy, immunogenicity levels, in adult patients with and safety profiles, including the extrapolation of active, clinically stable, moderate-to-severe plaque the indications. However, switching clinically stable psoriasis.33 Further investigation demonstrated that patients from originator biologics to their biosimilar switching between GP2017 and the reference prod- alternatives still raises some concerns, although uct up to 4 times had no detectable impact on the according to the available clinical trials and litera- efficacy, safety, or immunogenicity.33 ture reviews, a single switch from an originator to a On the other hand, a Dutch multicenter prospec- biosimilar is not associated with any significant risk tive open-label study of patients with inflammatory or loss of efficacy.36 Nevertheless, clinical evidence arthropathies, including psoriatic arthritis, anky- regarding the safety of multiple switches is limited, losing spondylitis, and rheumatoid arthritis (the and the IPC strongly endorses continued patient BIO-SWITCH study), investigated switching from monitoring using a registry and long-term observa- the originator infliximab to the biosimilar CT-P13.31 tional studies to provide more data. The IPC also Overall, 24% of 197 patients discontinued the treat- recognizes the need for careful monitoring of ment with the biosimilar because of a perceived lack patient after a treatment switch and detailed of effect, adverse events, or a combination of both.34 recording of the therapy prescribed in the medical Further analysis disclosed that 78% of the reported records. adverse events could be classified as subjective The manuscript was developed through the work of health complaints.34 This might be attributed to the the IPC BSWG. The IPC BSWG members who hold a nocebo effect associated with the patients’ negative postion in the paper are: Robert Strohal, Denis Jullien, expectations concerning the therapy, which may Wolf-Henning Boehncke, Nancy Podoswa, Marc Bourcier, have led to the subjective health complaints (ie, Claus Zachariae, Cesar Gonzalez, Omid Zargari, Menno de symptoms perceptible only by the patient) and Rie, Yves Poulin, Andr e Vicente Esteves de Carvalho, discontinuation of the therapy.35 The nocebo effect, Caitriona Ryan, Colby Evans, Peter Foley, Fernando which can also be defined as the opposite of placebo Valenzuela, Murlidhar Rajagopalan, Lone Skov, and Peter effect, may explain why the rate of discontinuation of van de Kerkhof. the therapy can be higher in open-label studies than in randomized controlled trials.30 These data suggest REFERENCES that acceptance and persistence rates after switching 1. Carrascosa JM, Jacobs I, Petersel D, et al. 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