Biosimilar Switching Research Articles

P232 Effectiveness of adalimumab biosimilar switching: real world data from a London rheumatology centre

Abstract Background Biologic drugs have revolutionised the management of many rheumatological diseases with remission or low disease activity now the realistic targets for treatment. However, given the chronic nature of most rheumatological disease and the need for long term treatment, there has been a significant increase in the cost associated with disease treatment. The advent of biosimilars offers an attractive target in reducing drug costs for payers. Biosimilar medications are thought to be equally efficacious as originator drugs. Real world data in adalimumab biosimilar switching is limited. In this audit we aim to examine the real-world outcomes from switching from originator Humira to biosimilar Amgevita in a London teaching hospital. Methods A list of all adult rheumatology patients on Amgevita was obtained through pharmacy records. All patients had been switched from Humira to Amgevita from February 2019. Using clinic letters and an in-house biologics database, data was collected on the underlying disease and the date of switch. Outcomes reviewed were disease activity scores pre and post switch, documented side effects and flare of disease activity following switch including decision to revert to originator Humira or change treatment. Results There was a total of 289 adult patients on Humira who switched to Amgevita. Of these patients, 28 in total discontinued treatment - 13 with rheumatoid arthritis, 10 with psoriatic arthritis and 5 with ankylosing spondylitis. 22 had to be switched back to Humira, with a further 4 patients approved to switchback and awaiting to restart. Two additional patients were switched to alternative biologic therapy due to inefficacy. A further 3 patients refused to switch onto Amgevita. Sixteen patients had documented flares, with one requiring admission and ten requiring local or systemic corticosteroid therapy to control activity. Seven patients had documented side effects which included chest pain, headache, rash and site reactions and one patient developed shingles post switch. Conclusion A total of 9.6% of patients switched to Amgevita had disease flare or side effects resulting in a switchback to Humira or alternative biologic therapy. For a biosimilar to be approved, efficacy and safety profiles needs to be comparable to the originator biological therapy and usually looks at two treatment naïve groups, rather than direct switch. Thereby, data on switches in therapy is limited. One systematic review looking at 11,053 patients with inflammatory arthritis treated with Etanercept and switched to Benepali, found 768 reverting to original therapy giving a lower total of 6.9%. We find that although no previous data of Amgevita, our figure of 9.6% appears high in the context of previously controlled inflammatory disease with Humira. Disclosures S. Vigneswaran None. M. Galloway None. S. Hanlon None. A. Tynan None. A. Singh None.

Who is afraid of biosimilars? Openness to biosimilars in an Australian cohort of patients with rheumatoid arthritis

Biosimilars are increasingly adopted to improve affordability of biologics. An effective introduction of biosimilars requires an understanding of patient acceptance of these agents. We performed a cross-sectional study of 132 patients with rheumatoid arthritis prior to the introduction of biosimilar switching or prescribing in this cohort. Despite being unfamiliar with biosimilars, most patients are willing to accept biosimilar medicines if recommended by their rheumatologist. Patient concerns about biosimilar uptake mainly focus on concerns about its efficacy. There is a significant correlation between patient attitudes towards biosimilar and generic medicines.

The Argument Against a Biosimilar Switch Policy for Infliximab in Patients with Inflammatory Bowel Disease Living in Alberta.

A nonmedical switch policy is currently being considered in Alberta, which would force patients on originator biologics to biosimilar alternatives with the hypothetical aim of reducing costs to the health care system. The evidence to support the safety of nonmedical switching in patients with inflammatory bowel disease (IBD) is of low to very low quality; in fact, existing data suggest a potential risk of harm. In a pooled analysis of randomized controlled trials, one patient would lose response to infliximab for every 11 patients undergoing nonmedical switching. Switching to a biosimilar has important logistical and ethical implications including potential forced treatment changes without appropriate patient consent and unfairly penalizing patients living in rural areas and those without private drug insurance. Even in the best-case scenario, assuming perfectly executed switching without logistical delays, we predict switching 2,000 patients with Remicade will lead to over 60 avoidable surgeries in Alberta. Furthermore, nonmedical switching has not been adequately studied in vulnerable populations such as children, pregnant women, and elderly patients. While the crux of the argument for nonmedical switching is cost savings, biosimilar switching may not be cost effective: Particularly when originator therapies are being offered at the same price as biosimilars. Canadian patients with IBD have been surveyed, and their response is clear: They are not in support of nonmedical switching. Policies that directly influence patient health need to consider patient perspectives. Solutions to improve cost efficiency in health care exist but open, transparent collaboration between all involved stakeholders is required.

Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease

Background and AimsBiosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn’s disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13.MethodsA literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed to contextualize data relevance.ResultsA total of 49 reports (3 randomized controlled trials, 40 observational trials, and 1 case series) were included. Most studies revealed no efficacy, safety, or immunogenicity concerns with non-medical switch. Limitations of supporting data include a small number of randomized controlled trials; predominance of observational studies with varying outcome assessments and lack of appropriate controls; and scarcity of research on biosimilar switch long-term effects.ConclusionsThe majority of studies suggested non-medical switch is safe. However, clinicians and regulatory bodies should be aware of differences and limitations in study designs when making inferences about the risks and benefits of switching stable IBD patients to biosimilars.

P505 Different failure rates after non-medical switching of 744 patients from adalimumab originator to 2 different adalimumab biosimilars at Cambridge University Hospitals, UK: real-world experience

Abstract Background Biosimilar adalimumab became available in the UK in October 2018, with payers introducing a series of measures to drive the adoption of the ‘best value’ adalimumab.1 Consideration of value should include risk of loss of efficacy and adverse reactions, which might drive further biologic switches or ‘reverse switches’ to originator. Managing potential ‘nocebo effect’ requires high levels of patient engagement, whilst the presence or absence of citrate buffer may affect patient-reported discomfort, hence patient treatment perceptions. Methods Patients were switched to 2 different biosimilar adalimumabs, one buffered with citrate (ADA1) and one in a citrate-free buffer (ADA2). The choice of adalimumab biosimilar was made for clinical and economic reasons. Patients were informed of the switch to either ADA1 or ADA2 in advance via letter and at clinic visits. Patients who reported problems after switching were reviewed. Results A total of 744 patients were switched from originator adalimumab (ADA0) to ADA1 or ADA2. Rheumatology and dermatology patients were switched to ADA1, whilst gastroenterology patients were switched to ADA2, except for those with a latex allergy, where ADA1 was used (or ADA2 in a latex-free syringe). A total of 49 (6.6%) patients reported problems and a further switch of drug was judged necessary in 48 (Table 1). Switch failure was significantly more likely with ADA1 than ADA2 (7.7% vs. 1.8%; p = 0.006). The median time to switch failure was 97 days (range 5–196 days). The commonest reason for switch failure was disease flare (23 patients, 48%), followed by injection site pain or reaction (21 patients, 44%). Disease flare and injection site problems were more likely to be reported with ADA1 than ADA2 (flare: 23/583 vs. 0/161, p = 0.008; injection site pain 20/583 vs. 1/161, p = 0.06). For patients reporting disease flare, clinicians tended to select a reverse switch to ADA0, whilst for those with injection site problems, a further switch to a different biosimilar was the preferred approach; both strategies were effective at recapture. Conclusion In the context of an effective patient communication strategy, adalimumab biosimilar switching was associated with overall low rates of patient-reported problems in a large cohort. Despite an identical communication strategy, significantly higher rates of injection site problems and disease flares were seen between 2 different biosimilars, reflected in a higher need for further switches. These differences may impact the cost-effectiveness of any chosen strategy. Reference

PBI55 FUTURE TRENDS ON THE BIOSIMILAR UPTAKE IN THE EU5 AND THE US

Biosimilar use creates an opportunity for increased patient access, drug competition and cost-savings, especially in a landscape driven by imminent patent-expiration of biologics. Study aimed to assess anticipated trends and incentives to enhance biosimilar uptake in the United States (US) and Europe’s big 5 (EU5: France, Germany, Italy, Spain, the United Kingdom). Targeted literature review was conducted in Medline/Embase, complemented with desk research. Differences in supply- and demand-side policies for biosimilars are impacting global market uptake. Successive policy shifts are seen following collection of biosimilar switching evidence and continuous debate to support further penetration of biosimilars to generate more economic savings. In France, biosimilar use became a part of the health strategy (2018-2022), aiming to achieve 80% of biosimilar penetration in 2022. Although automatic substitution was introduced by law in France (2014), it is still not implemented due to the lack of a published decree. In Germany, a bill allowing biosimilar substitution by pharmacists awaits for the legislative approval since 2018; due to criticism and revisions, implementation of this reform will be postponed by 3 years. Meanwhile, G-BA was mandated to introduce a list of interchangeable biosimilars to support physician-authorised switching. In Spain and the UK, hospital pharmacy stocking of a one preferred drug over tendering for multiple products is expected. Real-world evidence for Italy shows the increasing trend for biosimilar use with great variability among regions. Despite infancy in the US biosimilar uptake, the FDA released the Biosimilars Action Plan (2018) outlining 11 key actions to boost the biosimilar industry and facilitate access, with a guideline for demonstrating interchangeability (2019). Even though market share of biosimilars remains low, with except to some drug-tendering processes, regulations are evolving rapidly and a number of tools should be implemented in the near future to boost the biosimilar uptake in the following years.

Same but different? A thematic analysis on adalimumab biosimilar switching among patients with juvenile idiopathic arthritis

BackgroundBiologic medications have dramatically enhanced the treatment of many chronic paediatric inflammatory conditions. Their high cost is a factor that prohibits their broader use. Cheaper generic versions, or biosimilars, are increasingly being used. Healthcare services are switching some patients over to biosimilars for economic reasons, known as ‘non-medical switching’. Some patients unsuccessfully switch due to perceived decreases in efficacy or non-specific drug effects. The implications of failed switching include exhaustion of therapeutic options, unnecessary exposure to other medications, increased healthcare utilisation, worse patient outcomes and higher overall healthcare costs. Patient perceptions almost certainly play a role in these ‘failed switches’.MethodsA thematic analysis was performed to better understand patient and parent perceptions on non-medical biosimilar switching. The study was conducted in accordance with the Consolidated Criteria for Reporting Qualitative Research recommendations. Patients with juvenile idiopathic arthritis currently taking adalimumab were included.ResultsNine families were interviewed just prior to a hospital trust-wide non-medical switch to an adalimumab biosimilar. Several common themes were identified. The most frequent concerns were regarding practical aspects of the switch including the medication administration device type; the colour of the medication and administration device; and whether the injections would sting more. The relative safety and efficacy of the biosimilar was raised although most families felt that there would be no significant difference. Anxieties about the switch were largely placated by reassurances from the medical team.ConclusionsWe derived recommendations based on existing adult literature and the observations from our study to optimise the benefits from non-medical biosimilar switching.

P48 The puppet prescriber or custodian of the NHS purse: are patients really at the centre of what we do?

Abstract Background Biologic therapies have revolutionised the management of patients with rheumatological conditions; with considerable cost to the NHS. The switch of originators to biosimilar products was challenging. We aim to share our experience of adalimumab biosimilar switch and believe this is reflective of the challenges experienced in some other centres. The development of biosimilar aims to challenge the excesses of pharma profits by encouraging competition in the market place. Previous switches to intravenous biosimilar products had been uneventful. We were informed that the trust was implementing switch of biologics to biosimilar and later told biosimilar A was the biosimilar version allocated to us. This was a decision beyond the Trust, with NHS England deciding on the allocation. For our Trust, biosimilar A was allocated for patients weighing 30kg requiring a 40mg dose and biosimilar B allocated for patients weighing less than 30kg requiring a 20mg dose (NB: no 20mg preparation available for biosimilar A). Patients commenced on biosimilar B 20mg preparation can remain on biosimilar B and move on to its 40mg preparation once they weigh 30kg. Biosimilar A, the cheaper of the two preparations, contains preservative, citrate. Both biosimilars are double the volume of the originator biologic. Case a biologic-naïve 16 year-old patient was the first to be treated with the chosen biosimilar A, and, upon self-administrating; the patient clearly expressed a high level of pain. Following the experience with the patient the team felt that this was not an appropriate option. Methods With the feedback from the patient, rheumatology team highlighted the issues and focussed on high quality patient centred care not just focussing on the short term cost saving option but understanding that the patient engagement and compliance is cost saving in the long run. The team enquired with other specialities and regional paediatric rheumatology centres regarding their biosimilar switch. Results Liaising with the High cost pharmacy team, we successfully obtained authorisation to prescribe biosimilar B. We promptly switched the patient to biosimilar B and prescribe this now for all suitable to switch and new patients. So far there have been no negative comments or issues from the switch to the citrate free product. Conclusion It is vital that we provide an evidence based cost saving medication to treat children with long term conditions. However when new medications are being introduced, there needs to be greater consideration for the paediatric population which currently seems lacking. Collaborative working with the high cost pharmacy team, regular communications with other specialities, adult colleagues and involving the national nurse specialists group greatly benefitted us in managing this situation. More studies are required to identify patient factors involved in these scenarios. Conflicts of Interest The authors declare no conflicts of interest.

Implementing and delivering a successful biosimilar switch programme – the Berkshire West experience

Biosimilars used in multiple rheumatic conditions offer the -potential for cost savings. We present the outcomes of a -service evaluation of switching rheumatic patients established on originator etanercept (Enbrel) to biosimilar Benepali, using a managed switching programme funded through a novel fixed price incentivisation model. Evaluation outcomes included savings in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes and patient experience. A total of 154 patients on Enbrel were identified for switching. A total of 113 patients (43 had rheumatoid arthritis, 43 had axial spondyloarthritis and 27 had psoriatic arthritis) were switched from originator etanercept to Benepali from August 2016 to March 2017. The Royal Berkshire NHS Foundation Trust had the highest percentage of switches in the Thames Valley in this period. There was no increased incidence of side effects before and after switch. Drug acquisition costs were decreased by £95,000 with an overall reduction in prescribing costs of £186,000 for the local health economy. A managed switching programme from originator etanercept to biosimilar Benepali, using a novel fixed price model, delivers significant cost savings and investment in clinical services while maintaining similar patient-reported outcomes and good patient experience.

P447 The impact of therapeutic drug monitoring during biosimilar infliximab switch in inflammatory bowel disease

P447 The impact of therapeutic drug monitoring during biosimilar infliximab switch in inflammatory bowel disease

Switching to Biosimilars in Inflammatory Rheumatic Conditions: Current Knowledge

Biosimilars are more affordable versions of previously approved biopharmaceuticals that are designed to reduce healthcare expenditure and increase patient access to this therapeutic class. To achieve their economic potential, many European countries have started to switch patients from reference drugs to biosimilars. The purpose of this article is to provide a comprehensive perspective on the biosimilar switching controversy, to assess interchangeability regulation and switching policies, and to review current evidence on switching and immunogenicity in the context of inflammatory rheumatic conditions. Patients and physicians feel uncertain about switching highly complex and difficult-to-replicate biosimilars of monoclonal antibodies due to a theoretical risk of increased immunogenicity, especially in extrapolated indications and in a multiple switch scenario involving various biosimilars. However, past experience with smaller biosimilars (somatropin, filgrastim, epoetin), the high standards required for approval of biosimilars of monoclonal antibodies in the European market, and current evidence on switching to infliximab and etanercept biosimilars (especially CT-P13 and SB4) are reassuring. Furthermore, no increased immunogenicity has been reported after switching to biosimilars. Decisions on switching and interchangeability are not covered by the European Medical Agency (EMA) guidelines and are left to individual European states, as opposed to the U.S. Food and Drug Administration (FDA), which has set standards to assess interchangeability. In summary, current knowledge is in favour of switching to biosimilars but the authors consider that this should be a physician-led decision with the active contribution of patients and hospital pharmacists to the pharmacovigilance chain.

Biosimilar switching and related medical liability

Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of naïve patients is different from that of non-naïve patients. In the case of naïve patients, physicians make their choice from a range of medicinal products that pose the same risk, since it is not possible to know with any certainty the patients' response to each therapeutic option until they have taken the drug. If physicians, instead, switch to a biosimilar for a patient already in treatment with the originator, they are switching from an option where the individual response is known, to an option where it is unknown.Given the evolving framework of biosimilar legislation, sharing choices with patients and obtaining their informed consent when switching to a biosimilar could represent an effective approach on the part of the prescribing physician. Moreover, a supranational database containing real-life data about patients in treatment with biological medicines, including information on the actual biological medicinal products administered, could complement the data obtained from clinical studies.

Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

Background The efficacy, safety and immunogenicity risk of switching between an originator biologic and a biosimilar or from one biosimilar to another are of potential concern.Objectives The aim was to conduct a systematic literature review of the outcomes of switching between biologics and their biosimilars and identify any evidence gaps.Methods A systematic literature search was conducted in PubMed, EMBASE and Cochrane Library from inception to June 2017. Relevant societal meetings were also checked. Peer-reviewed studies reporting efficacy and/or safety data on switching between originator and biosimilar products or from one biosimilar to another were selected. Studies with fewer than 20 switched patients were excluded. Data were extracted on interventions, study population, reason for treatment switching, efficacy outcomes, safety and anti-drug antibodies.ResultsThe systematic literature search identified 63 primary publications covering 57 switching studies. The reason for switching was reported as non-medical in 50 studies (23 clinical, 27 observational). Seven studies (all observational) did not report whether the reasons for switching were medical or non-medical. In 38 of the 57 studies, fewer than 100 patients were switched. Follow-up after switching went beyond 1 year in eight of the 57 studies. Of the 57 studies, 33 included statistical analysis of disease activity or patient outcomes; the majority of these studies found no statistically significant differences between groups for main efficacy parameters (based on P < 0.05 or predefined acceptance ranges), although some studies observed changes for some parameters. Most studies reported similar safety profiles between groups.Conclusions There are important evidence gaps around the safety of switching between biologics and their biosimilars. Sufficiently powered and appropriately statistically analysed clinical trials and pharmacovigilance studies, with long-term follow-ups and multiple switches, are needed to support decision-making around biosimilar switching.Electronic supplementary materialThe online version of this article (10.1007/s40259-017-0256-z) contains supplementary material, which is available to authorized users.

Pharmacotherapy: Biosimilar switching - "To set a form upon desired change".

The highly anticipated NOR-SWITCH trial results provide valuable information for patients and physicians concerned about the effects of switching between a biologic agent and a biosimilar product. However, the possibility of frequent switches, potentially involving more than one biosimilar, raises more questions.

P527 Infliximab biosimilar switching program overseen by specialist pharmacist saves money, realises investment and optimises therapy

P527 Infliximab biosimilar switching program overseen by specialist pharmacist saves money, realises investment and optimises therapy

PWE-017 Prospective Evaluation of The Safety and Efficacy of Switching Stable Patients with Inflammatory Bowel Disease from Remicade™ to Biosimilar Infliximab (IFX)

Introduction Biosimilar IFX (CT-P13; RemsimaTM/InflectraTM) became available in the UK in February 2015 offering significant savings to the NHS. Efficacy and safety data in inflammatory bowel disease (IBD) is limited. From May 2015 IBD patients at the Royal Devon and Exeter NHSFT were switched from RemicadeTM to Biosimilar IFX. We reviewed efficacy and safety data during this switch. Methods Treatment was evaluated in IBD patients who met the following criteria: i) RemicadeTM treatment for greater than 6 months prior to switch ii) minimum follow-up data of 6 months following switch. Disease activity scores (Harvey-Bradshaw Index for Crohn’s disease [CD] and Simple Colitis Score for ulcerative colitis [UC]), CRP, drug levels and total anti-drug antibody levels were collected immediately prior to biosimilar switch and then every 16 weeks. All adverse events were recorded. Results 104 patients (54 male) met the inclusion criteria with a mean age of 43 years (range 17–71). 73 had CD, 29 had UC and 2 had IBD-unclassified. The median duration of RemicadeTM therapy prior to switch was 1137 days (95% confidence interval = 933–1290). Missing cases were excluded on a variable by variable basis. There was no significant difference in CRP (median pre-switch = 2, post-switch = 2, P = 0.81) or disease activity score (median pre-switch = 1, post-switch = 1, P = 0.44) after switching from RemicadeTM to Biosimilar IFX. 85% were in remission before compared with 81% six months following switch (P = 0.51). There was no difference in the number of people with detectable total anti-drug antibody levels (pre-switch = 29, post-switch = 27, P = 0.88) but a fall in drug levels was noted after switching (median pre-switch =5.4, post-switch = 2.8, P = 0.01). 41% had significant anti-drug antibodies pre-switch compared to 36% at 6 months post switch (P = 0.50). 11% of patients had positive anti-drug antibodies with undetectable drug levels pre-switch compared to 7% at 6 months (P = 0.35). 4 patients had adverse events within eight months of switching to biosimilar IFX; 2 minor infusion reactions and 2 anti-TNF induced skin disease. 19 patients stopped within six months of switching; 6 electively, 9 due to loss of response and 4 for other reasons. Conclusion This uncontrolled data suggests biosimilar IFX is safe and effective with no significant change observed in CRP, disease severity index and drug antibody levels six months after switch. The fall in IFX drug level after switch warrants further investigation. Disclosure of Interest K. Bennett: None Declared, G. Heap Grant/research support from: Hospira, Knapp, Abbvie, MSD, S. Hawkins: None Declared, T. Ahmad Grant/research support from: Hospira, Knapp, Abbvie, MSD

How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009-2014.

Granulocyte colony-stimulating factors (G-CSFs) are biological products for which the main indication of use is chemotherapy-induced neutropenia. Biosimilars of G-CSFs have been available in Europe since 2007. The objective of this study was to investigate the prescribing pattern of G-CSFs in five Italian centres using different healthcare policy interventions to promote the use of biosimilars in routine care. This retrospective, population-based drug utilization study was conducted during the years 2009-2014 using the administrative databases of the Caserta, Treviso and Palermo Local Health Units (LHUs) and the Tuscany and Umbria regions. G-CSF users were characterized and the prevalence of use, proportion of biosimilar users and switching pattern of different G-CSFs were evaluated over time and across centres. Overall, 30,247 patients were treated with G-CSFs in the years 2009-2014, of which 29,083 (96.2%) were naïve users. The overall prevalence of G-CSF use increased from 0.8 per 1000 inhabitants in 2009 to 1.1 per 1000 in 2014. An increase in the proportion of the use of the biosimilar filgrastim by the total G-CSF users was observed in all centres: from 0.2% (2009) to 66.2% (2014). However, heterogeneity across different centres was reported, with the largest increase in Treviso LHU (from 0 to 89.1% from 2009 to 2014). During the first year of treatment, switching between different G-CSFs was frequent (20.3%). Heterogeneity in the use of G-CSF and, in particular, biosimilar filgrastim across different Italian centres was observed, probably due to different regional healthcare policy interventions. During the first year of treatment, switching between different G-CSFs was frequent. Considering the impact of biological drugs on pharmaceutical expenses, it is necessary to harmonize healthcare policies promoting the use of biological drugs with the lowest cost.

Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia

Clinical efficacy and safety of SB309, a biosimilar recombinant human erythropoietin, in the management of anemia Alaa Bagalagel,1,2 Abdulaziz Mohammed,1,2 Karen MacDonald,3 Ivo Abraham1,3&ndash;5 1Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA; 2College of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 3Matrix45, Tucson, AZ, USA; 4Department of Pharmacy Practice and Science, College of Pharmacy, 5Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA Abstract: In this second part of a series of three reviews of approved biosimilar erythropoietins, we review the evidence pertaining to the clinical efficacy and safety of SB309 relative to the originator product Eprex&reg;/Erypo&reg;. As in the first review, clinical efficacy is assessed with respect to the therapeutic equivalence of the biosimilar and originator product, while safety is evaluated in terms of immunogenicity, venous thromboembolism, and mortality. Seven studies in chronic renal failure and oncology populations are reviewed. In the renal setting, these include two randomized controlled trials on hemoglobin correction and maintenance in patients receiving long-term hemodialysis; open extension safety studies from both trials analyzed as a pooled database; a post hoc analysis on biosimilar and originator switching; a therapeutic equivalence study of subcutaneously administered SB309 and Eprex/Erypo; and a single-center experience study. In the cancer setting, one open-label non-controlled study is reported. Based on the available therapeutic equivalence and safety data, the clinical and safety outcomes of treatment with SB309 are likely to be similar to those of the originator product Eprex/Erypo. Both products can be considered interchangeable in the management of anemia for the approved indications. Patients transferred from reference product to biosimilar can be expected to show the same efficacy and safety outcomes. There is no evidence of the interchangeability of SB309 with other biosimilar or originator erythropoietins. In keeping with European Medicine Agency guidance regarding traceability, it is recommended that clinicians document the product by its commercial name, especially when switching patients from originator to biosimilar or vice versa. Keywords: biosimilars, biosimilar pharmaceuticals, efficacy, safety, erythropoietin, recombinant proteins