Biosimilar Medications Research Articles

The cost of treating inflammatory bowel disease: step-up vs step-down, therapeutic drug monitoring and personalised medicine

Inflammatory bowel disease (IBD) is a group of lifelong immune-mediated diseases, including Crohn's disease and ulcerative colitis. IBD is traditionally treated with drugs, including 5-aminosalicylates, steroids and immunosuppressants. However, the treatment landscape is changing, owing to a number of factors of significance to the IBD clinical nurse specialist. The recent introduction of novel biologic and biosimilar medications has affected the efficacy and cost of treatment. The established step-up treatment paradigm, where patients are started on simpler, cheaper therapies, is shifting toward a step-down approach, where biologics are the first-line treatment. Meanwhile, nurse-led pro-active therapeutic drug monitoring, including patient-reported outcome measures (PROMs), is helping ensure the efficacy and safety of treatment and allows for adjustments. In the near future, personalised medicine may offer genetic testing to predict a patient's reaction to different drugs and identify the most appropriate therapies. At the author's hospital, some of these factors may have contributed to a 50% reduction in emergency surgical rates for ulcerative colitis. This clinical review examines these issues in light of real-world experience from the author's hospital.

Knowledge and Attitude of Pharmacists about Biosimilar Medications in Saudi Arabia

Objectives: This study determined knowledge and attitude of pharmacists about biosimilar mdications in Saudi Arabia. Methods: Pharmacists from different areas and regions were approached to participate in this cross-sectional study. Data were collected by a pre-validated and selfadministered research tool using a convenience sampling technique. Analyses and interpretation of the data were done using descriptive and inferential statistics with Statistical Package for Social Sciences (SPSS) version 24.0. Results: A total of 319 pharmacists from different specialties participated in the study. A total of 111 pharmacists were males, and 208 were females. All of the pharmacists had varied expertise. Around 41.4% of the studied pharmacists were practicing in the community, 34.5% in hospitals and 24.1% were in other areas. Conclusion: This study reported the current level of pharmacists’ knowledge and attitude about biosimilar medications in Saudi Arabia. Statistically, a significant association was observed between male and female pharmacists regarding the introduction of biosimilar medications in the Saudi Arabian healthcare setup.

Making the switch: a retrospective case series of our departmental experience of biosimilar medications

Making the switch: a retrospective case series of our departmental experience of biosimilar medications

Cost savings of biosimilars in oncology: A single institution experience.

10 Background: Biosimilar medications have increasingly gained regulatory approvals in recent years. Numerous conditions in the fields of hematology, oncology, rheumatology, and endocrinology have a biosimilar treatment option available. Some biosimilar agents can be obtained at a significantly lower cost than reference medications. Methods: Intermountain Healthcare Oncology Pharmacy and Therapeutics (P&T) committee manages and maintains the formulary of accepted drugs. The committee consists of pharmacists, medical oncologists and oncology nurses. Biosimilar medications were approved in place of reference medications for the following: pegfilgrastim, bevacizumab, trastuzumab, and rituximab. Results: Annually, we administer about 6,450 combined doses of pegfilgastrim, bevacizumab, trastuzumab, and rituximab. Assuming 70% conversion from the reference medication to biosimilar agent, transitioning from the above listed reference medications to biosimilar would save an estimated $6.3 million annually (Table). This includes a $1.75 million savings from transitioning to rituximab alone. In addition, transitioning trastuzumab from a single dose vial to multi-dose vials is estimated to save an addition $730,000. Conclusions: Biosimilar agents can reduce the cost of oncology care to patients treated at our institution. We are utilizing biosimilar agents as part of our ongoing mission to decrease the financial toxicity of treatment for patients with cancer. [Table: see text]

Biosimilar Uptake in Academic and Veterans Health Administration Settings: Influence of Institutional Incentives.

To compare uptake in the ordering of biosimilars at a Veterans Affairs Medical Center (VAMC) to that at an academic medical center, where institutional incentives for infused medications differ. We performed a cross-sectional study of medical record data and estimated institutional financial incentives at 2 medical centers in Philadelphia: 1) the University of Pennsylvania Health System (UPHS), and 2) the local VAMC.All ordering events for filgrastim or infliximab products were quantified over time and stratified according to product (biosimilar versus reference product) and center. Financial incentives to the institutions over time were determined based on actual drug costs for the VAMC and average sales prices (ASPs) and Medicare Part B reimbursement rates for UPHS. There were 15,761 infusions of infliximab at UPHS, of which 99% were for the reference product. There was a sharper decline in the use of reference products at the VAMC; 62% of the 446 infliximab infusions ordered at the VAMC were for the reference product. ASPs were consistently lower for biosimilar infliximab products, but the estimated institutional financial incentives remained similar over time for biosimilar and reference infliximab at UPHS. At the VAMC, the costs for 100-mg vials of reference infliximab and infliximab-abda were $623.48 and $115.58, respectively: a $507.90 (81%) savings per vial. The uptake of infliximab biosimilars has been slow at an academic medical center compared to a nearby VAMC, where financial savings are realized by the institution from its use. Slow adoption of biosimilar medications may impact the rates of decline in costs.

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.

Potential and Realized Cost Savings with the Use of the Biosimilar Grastofil Vs Neupogen

Background: Filgrastim was first introduced to the Canadian marketplace as Neupogen® in 1992 to treat neutropenia caused by chemotherapy regimens. In 2009, the first biosimilar drug was approved for use in Canada, and in March 2016, a biosimilar for filgrastim (Grastofil®) became available. Biosimilars represent safe, effective, and cost effective alternatives to originator biologic medications. However, although biosimilar medications present opportunities for significant cost savings to the health care system, overall uptake and use of biosimilar medications in North America has been low. The aim of this study was to describe the overall use of the filgrastim products Grastofil® and Neupogen® in Canada. Methods: A retrospective analysis of Canadian drug purchases between July 2016 and June 2018 was performed for the drug filgrastim (Neupogen®, Grastofil®). The data used to estimate drug purchases were obtained from IQVIA™, a multi-national healthcare analytics company. Samples from the IQVIA™ Canadian Drugstore and Hospital Purchases (CDH) audit covered greater than 88% of the hospital market and one-third of the retail market. Samples were stratified by region, market size, and type of outlet (e.g. cancer centers, long-term care). For each drug, the total purchase dollar amounts were provided by province on a month by month basis. Potential cost-savings were calculated as a product between the units of each product purchased and the cost difference between Neupogen® and the biosimilar Grastofil® on a quarterly basis for each province. Results: Between July 1st, 2016 and June 30th, 2018, Grastofil® accounted for 27.0% (382,254/1,415,762 units) of filgrastim purchases. During this time period, $62,061,576 was spent on Grastofil® purchases and $204,152,590 was spent on Neupogen® purchases. Through use of the biosimilar Grastofil®, $13,443,873 (37.0%) in savings were realized. Had there been 100% use of the biosimilar Grastofil®, it would have resulted in $36,348,476 in cost savings. In the first quarter (July to September 2016) Grastofil® accounted for 1.5% of filgrastim purchases, whereas in the April to June 2018 quarter it increased to 43.6% of filgrastim purchases. The overall percentage of filgrastim units purchased by Canadian province varied substantially. The market share captured by Grastofil® ranged from a low of 0.08% ($4007/$5,189,623) in the province of Nova Scotia, to a high of 81.62% ($932,864/$1,142,905) in the province of Saskatchewan. Canada's largest province, Ontario, saw Grastofil® account for 44.7% ($9,047,489/$20,229,421) of purchases during this time period. Discussion: Although the biosimilar Grastofil® only accounted for 27% of filgrastim purchases between 2016 and 2018, there was substantial growth over this time period. By the end of June 2018, Grastofil® accounted for approximately 44% of filgrastim purchases, which is substantially higher than other biosimilar medications currently available in Canada. There are also stark differences between each province, whereas some had little to no use of the biosimilar, whereby in other provinces the purchases of Grastofil® outnumbered the purchases of Neupogen®. Had there been exclusive use of the biosimilar, an additional $23 million dollars in savings could have been realized. Conclusions: The use of biosimilars represents an opportunity for cost savings to be realized in an over-extended health care system. Although there appears to be acceptance for the use of Grastofil® as the overall purchases trended up from 2016 to 2018, there are still significant cost savings that could be realized by greater use of biosimilar drugs. Disclosures Mansell: Apobiologix: Research Funding.

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

Multiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT). These medications include injectable complex nonbiological drugs (CNBD), the injectable biological products β-interferons-1a and -1b, and the infusible monoclonal antibodies (MAB), as well as oral synthetic therapeutic molecules. The degree of efficacy and adverse effects profile is variable. By the end of 2019, all medications have been approved for relapsing forms of MS, including five with indication for clinically isolated syndrome (CIS), two for active secondary progressive MS, and one for primary progressive MS. With the advent of the first generation or “platform” injectable DMT in the 1990s the cost of MS care increased substantially driven basically by the cost of these therapies. As new drugs licensed by health agencies appeared in the global market, the cost of these agents notably increased augmenting the economic gravamen of disease particularly in North America This industrial phenomenon has been promoted by the remarkable profits obtained by the biopharmaceutical companies producing these medications, costs increasing about seven times per patient per year in the span of two decades. The global MS drug market was valued at US$16.3 billion in 2016, expecting to reach US$27.8 billion by 2025. The societal and economic effect of these costs constitute an international concern for health systems which adjudicate an increasing portion of financial resources to MS care. This effect has had a more notorious impact in emerging countries with economies in development. In the early 2000s the industry producers of biosimilar molecules initiated the concept of manufacturing follow-on biosimilar therapeutic options for MS available at a reduced cost without affecting efficacy and safety. Latin American biotechnological companies from Mexico, Argentina and Uruguay, introduced into the regional markets biosimilar β-interferons. These products were licensed by the local regulatory agencies without challenging pharmacological profile and their claims of similarity with the innovator medications. In the licensing process, biosimilar manufactures have typically utilized published literature and phase III clinical trials data previously acquired by the brand medication (“third approval pathway’’). This has raised concerns among local neurological communities and patient organizations in the area. This situation is compounded by the fact that no discernible health cost savings have resulted since their introduction in Latin American countries. In some European countries where the health care system, public and private systems, regulated by Ministries of Health, negotiate with the pharmaceutical industry drug pricing and payment systems. The business scenario has stimulated local industries to produce follow-on biosimilar medications, theoretically to compete or replace the original brands. Countries such as Iran who have experienced a substantial increase in MS prevalence (101.19 per 100,000 inhabitants) has enabled their national Food and Drug Organization (FDO) to license locally produced biosimilar interferon 1-a and 1-b based on somewhat limited clinical studies. The Ministry of Health of the Russian Federation, approved the first biosimilar β-interferon-1a (44 mcg subcutaneous administration) manufactured in the country and developed in accordance to the guidelines of the European Medicine Agency (EMA) for phase I and phase III studies. The EMA, however, along with other international licensing agencies: United States Food and Drug Agency (FDA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the UK Medicines and Healthcare Products Regulatory Agency (MHPRA), and others, have produced strict guidelines regulating registration of biosimilar medicines. Thus far these agencies have not approved any interferon or MAB for MS based on these principles. The main obstacles for the approval of biosimilar medications by international health agencies is their consistent inability to demonstrate therapeutic equivalence through physiochemistry, biology, immunogenicity aspects, molecular behavior and clinical studies, preferably through a controlled phase III study, or ideally, utilizing a comparative head-to-head trial with the innovator. Recommendations proposed by experts from the Latin American region to guarantee production quality of biosimilar products, efficacy and safety, include strict application of current regulations; avoid uncontrolled interchangeability; implement strong pharmacovigilance; educate healthcare professionals and regulatory officials on the different issues involved in the biosimilarity concept and use evidence-based decision for therapy selection. The main priority should always be the protection and well-being of the patient irrespectively of therapy availability or pharmacoeconomic issues.

Knowledge, Behaviours and Attitudes of Pharmacy Professionals regarding Biosimilar Medications

Knowledge, Behaviours and Attitudes of Pharmacy Professionals regarding Biosimilar Medications

Efficacy of Biosimilars in Psoriasis

Biologic therapies have revolutionized the treatment of moderate-to-severe psoriasis, and several biologic agents are currently available to patients. However, the high cost associated with these drugs contributes to the underutilization of biologics and the resultant undertreatment of disease. In recent years, biosimilars have been developed for several of the commonly used biologic agents, with reported similar efficacy and safety profiles to the original agents. They are also somewhat less costly than the original biologic agents that they are similar to. Despite this, many dermatologists are still skeptical of biosimilars for a variety of reasons. It is important for dermatologists to familiarize themselves with the emerging safety and efficacy data for the biosimilar agents, so as to provide patients with safe, efficacious, and potentially affordable treatment options as biosimilars become available over the next several years. In this article, we set out to review available data regarding biosimilar medications in the treatment of psoriasis. A literature review was performed utilizing the PubMed database. The results of these studies indicate that biosimilars have a high degree of similarity regarding safety and efficacy when compared to their originator biologics for the treatment of psoriasis.

Patient attitudes about non-medical switching to biosimilars: results from an online patient survey in the United States

Objective: To evaluate patient attitudes regarding non-medical switching (NMS) to biosimilars among patients with autoimmune disease currently receiving a biologic.Methods: An online survey was conducted among patients meeting the following criteria: ≥18 years of age; residing in the US; diagnosis of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis or psoriatic arthritis; currently taking a biologic; and consenting to participate. Patients answered questions about their attitudes and experiences related to NMS. Descriptive statistics were used to summarize responses.Results: A total of 1696 patients completed the 20-min survey. Eighty-five per cent of patients were concerned that biosimilars wouldn’t treat their disease as well; 85% didn’t want to switch to a biosimilar if their current biologic was helping their disease; and 83% were concerned that switching may cause more side-effects. Twenty per cent of patients had previously received notification about a potential NMS to another biologic (that was not a biosimilar) from their insurance company. Of these, 79% took at least one action to avoid the NMS and 45% ultimately switched. Of these patients (n = 150), 67% indicated that their previous biologic worked well for them and 70% didn’t want to switch to another biologic. Most patients who switched (67%) did so to avoid paying a higher cost. More than half (56%) went without therapy for administrative reasons during the period of transition from the old biologic to the other treatment.Conclusions: Patients reported multiple concerns about NMS that might impact treatment outcomes, and many of the patients who non-medically switched in this survey missed treatments. Future studies should be conducted on patient expectations and experiences with NMS to understand the impact on healthcare delivery, treatment persistency, and patient outcomes. The patient perspective and experience should be considered by decision-makers when developing coverage policies for biosimilar medications and associated communication strategies.

Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States.

The utilization of trastuzumab biosimilar medications is of particular interest in HER2-positive breast cancer as these drugs have the potential for cost savings and increased utilization/access to HER2 targeted therapy in both early stage and metastatic HER2-positive breast cancers. Five trastuzumab biosimilars: MYL-1401O (Ogivri), CT-P6 (Herzuma), SB3 (Ontruzant), PF-05280014 (Trazimera), and ABP980 (Kanjinti), have now been approved by the US Food and Drug Administration (FDA) for use in HER2-positive breast cancers. This review provides an overview of these agents with special consideration of the development and approval process, including available clinical data results for these trastuzumab biosimilars. Adoption in the clinic will depend on the degree of comfort with the overall evidence.

Farmakoekonomiczna ocena kosztów terapii reumatoidalnego zapalenia stawów wybranymi lekami biologicznymi

ObjectivesAmong autoimmune diseases, rheumatoid arthritis (RA) is the most common chronic inflammatory disease of the joints. Its pathogenesis is still not fully understood, but the gained knowledge has contributed to the development of modern treatment. The introduction of biological therapy for RA has been a breakthrough in the standard approach to the treatment of this disease.Material and methodsThe study material was retrospectively collected in the Rheumatology and Systemic Tissue Diseases Clinic and Rheumatology Outpatient Clinic in dr. Jan Biziel University Hospital No. 2 in Bydgoszcz. Patients were divided into 3 groups: patients receiving infliximab – 43 patients, etanercept – 27 patients and adalimumab – 34 patients. In the study, the pharmacoeconomic analysis included direct and indirect medical costs. Direct medical costs analyzed in the study included costs for the purchase of medications, diagnostic and imaging costs, and medical consultations and hospitalization costs. The analysis included all direct medical costs incurred by the hospital and the patient, as well as indirect costs outside the healthcare sector – that is, the Polish Social Insurance Institution benefits (disability benefits, rehabilitation benefits, sickness absences). Direct medical costs are also presented from the perspective of the payer – The Polish National Health Fund – taking into account the cost and percentage share of medical expenses.ResultsThe analysis concerned resources used since the beginning of treatment with a given biological medication for 24 months or earlier if disease remission occurred.A cost-benefit analysis was carried out in the study using biosimilar medications present on the market in relation to the treatment regimens. Considering the total cost, if only Inflectra were used in therapy, PLN 18 151.98 per patient could be saved, and in the case of Remsima, PLN 16 385.14. In less than 19 months, to use infliximab for 43 patients, PLN 780 475.80 more would have to be spent than in the case of the biosimilar medication Inflectra, and PLN 704 561 in the case of Remsima.The highest total cost is generated by treatment with adalimumab, followed by etanercept, and infliximab. Of the costs analyzed, a significant majority was for biological treatment.ConclusionsGiven the Polish financial conditions, the best solution now is to reduce the prices of biological medications. This is possible through the introduction of biosimilar medications that, when placed on the market, reduce the price of the original medication, as is currently the case with Remicade and Enbrel. The introduction of Inflectra and Remsima, as well as Benepali and Erelzi, has reduced the price base of original medications to similar levels of treatment with biosimilar medications. The wider use of biological treatment would also reduce indirect costs.

GP2015 as a promising therapy for rheumatoid arthritis

ABSTRACTIntroduction: Rheumatoid arthritis is a common inflammatory joint disease with a myriad of systemic manifestations. Over the last 20 years its treatment has been revolutionised by the introduction of a number of different biologic drugs, including the TNF-receptor Fc fusion protein, Etanercept. However, these drugs are expensive and their widespread use puts a financial burden on healthcare systems. As many biologic treatments begin to come off patent new ‘biosimilar’ versions are being developed which can lead to significant cost savings. GP2015 (Erelzi®) is the second biosimilar version of Etanercept which is licensed for the treatment of rheumatoid arthritis.Areas covered: We discuss the Chemistry, pharmacokinetics and pharmacodynamics of GP2015 in relation to reference Etanercept. Preclinical trials have shown pharmacokinetic equivalence between GP2015 and the reference drug. The recently completed Phase III, randomised, double blind EQUIRA study has shown equivalent efficacy and safety between GP2015 and Etanercept in patients with rheumatoid arthritis.Expert opinion: GP2015 has shown equivalent efficacy and safety to reference Etanercept. With a growing number of biosimilar medications becoming available and another biosimilar Etanercept already being widely prescribed it is likely to be the cost of the drug that will determine if it is used widely.

Patient Perceptions Regarding the Use of Biosimilars in Inflammatory Bowel Disease

Introduction: Inflammatory bowel disease (IBD) often requires treatment with immune modulating medications (biologics). Although biologic agents have been shown to have excellent efficacy in treating IBD patients, the substantial cost has become a barrier to treatment for many patients. Recently, biosimilar drugs have been developed. Many clinical trials have demonstrated similar efficacy of biosimilars compared to originator biologics in IBD patients. Patients' perception and knowledge regarding these drugs is not known. We surveyed IBD patients to assess perceptions and knowledge regarding biosimilar medications and willingness to switch from biologics to biosimilars.Table: Table. Characteristic DataMethods: 121 consecutive adult patients in a single outpatient gastroenterology clinic with a pre-existing diagnosis of IBD were surveyed between March and May 2017. Data was then compiled and analyzed. Patients were excluded if they were not able to read English. Results: The mean age of the survey participants was 37.8 ± 15.5 years. Sixty-three percent of the participants were male. Fifty-three patients (43.8%) carried a diagnosis of UC. Sixty-seven patients (55.3%) had Crohn's disease (CD). One patient was not sure of his/her diagnosis. Significantly more CD patients than UC were currently on infliximab or adalimumab (35 vs 16, p=0.014). Only 33 participants (27%) have heard of “biosimilar medications” prior to this study. Seventy-six percent of all participants were uncomfortable using a biosimilar medication that had not been tested in clinical trials specifically for UC or CD. 57% participants were uncomfortable exchanging their current medication for a biosimilar. 92% of all participants wanted to be informed prior to switching to a biosimilar medication. There was a statistically significant correlation between the number of years since diagnosis and the patient's comfort with switching to a biosimilar medication (r=0.203, p=0.027). Conclusion: By investigating patient perceptions and knowledge regarding biosimilars, we hope to better understand patients' level of comfort, preferences, and potential barriers to implementation. Most IBD patients were uncomfortable using a biosimilar that has not been evaluate in a clinical trial in IBD. Of interest, a longer time since diagnosis of CD was associated with increased comfort of switching from biologic to biosimilar. This information will help physicians form their approach to introducing and discussing these biosimilars with patients.Table: Table. Patient Pereceptions Regarding Biosimilar Medications

The growing role of biologics and biosimilars in the United States: Perspectives from the APhA Biologics and Biosimilars Stakeholder Conference

ObjectivesThe American Pharmacists Association (APhA) convened the Biologics and Biosimilars Stakeholder Conference on November 30, 2016, in Washington DC. The objectives of the Conference were to determine the key issues and challenges within the marketplace for biologics, follow-on biologics (FOBs), and biosimilars, identify potential roles and responsibilities of pharmacists regarding biologic and biosimilar medications, and identify actions or activities that pharmacists may take to optimize the safe and cost-effective use of biologics and biosimilars. Data sourcesNational thought leaders and stakeholder representatives, including individuals from the Food and Drug Administration, Centers for Medicare and Medicaid Services, a private third-party payer, manufacturers, and several national organizations of health care professionals, participated in the conference. Information shared by this group was supplemented with relevant legal and regulatory information and published literature. SummaryBiologics play a valuable role in the treatment of numerous health conditions, but their associated costs, which tend to be greater than those of small-molecule drugs, place a burden on the health care system. Biosimilars (both noninterchangeable and interchangeable) are highly similar copies of the originator biologic and offer the potential to reduce costs and improve patient access to biological products by increasing treatment options and creating a more competitive market. Despite the potential benefits of biosimilars, certain factors may limit their uptake. The conference participants explored issues that different stakeholders think influence the use of biologics, including biosimilars, in the United States. Barriers included technology, prescriber–pharmacist communication, legislation and regulations, limited patient and health care practitioner knowledge of biological products, patient and health care practitioner perceptions of biosimilars, and evolving science or lack of long-term data. After participants identified issues, they discussed strategies to address these concerns, including the need to enhance the education of pharmacists, prescribers, and patients regarding biologic products, including biosimilars and FOBs; the passage of state laws and regulations that do not impede the use of biosimilars, including interchangeable biosimilars; the use of product-specific tracking information in electronic health records and surveillance systems; bidirectional communication among pharmacists, prescribers, and other members of the care team to support pharmacovigilance and the maintenance of accurate patient records; and the development of evidence-based third-party payer policies. ConclusionPatient access to safe and cost-effective treatments is an important goal for the health care system. As the availability and use of biosimilars, including those determined to be interchangeable, increases, their potential to lower costs and improve patient access to treatment grows. However, the extent of such growth is, in part, dependent on various stakeholders’ decisions to provide, pay for, or use these products in a safe and thoughtful manner. Ongoing stakeholder collaboration, educational activities, and review of current government or payer policies are required to optimize the uptake of biological products, including biosimilars.

The Role of Infliximab Biosimilar CT-P13 in Inflammatory Bowel Disease

The advent of targeted biologic therapies for debilitating disorders such as Crohn’s disease (CD) and Ulcerative Colitis (UC) has changed management and significantly improved outcomes. However, biologic agents are expensive, and the introduction of biosimilar medications for the treatment of inflammatory bowel diseases presents a lower-cost alternative. In this review, the mechanism of action, pharmacokinetics, efficacy and adverse effects associated with biosimilar CT-P13 in the treatment of inflammatory bowel disease are discussed.

Biosimilars: new promise for reducing healthcare costs

After much anticipation, approval of the first U.S. biosimilar medications may be around the corner. Biosimilars hold the promise of reducing healthcare spending by offering lower-cost alternatives to high-priced biologic drugs. Biosimilars are not generic versions of existing biologics, however. Generic medications contain an active ingredient identical to that in the reference (“brand-name”) product. A biosimilar may contain an active ingredient slightly different from the reference product, as long as the differences are not clinically meaningful. The Food and Drug Administration (FDA) describes a biosimilar as highly similar to the reference product notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency of the product.[1].