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2.
BMC Cancer ; 22(1): 960, 2022 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-36071409

RESUMO

BACKGROUND: Breast cancer is the most frequently diagnosed cancer and the leading reason for cancer-related death among women. Neoadjuvant treatment with dual-HER2 (human epidermal growth factor receptor 2) blockade has shown promising effects in this regard. The present study aimed to compare the efficacy and safety of a proposed pertuzumab biosimilar with the reference pertuzumab. METHODS: This randomized, phase III, multicenter, equivalency clinical trial was conducted on chemotherapy-naive women with HER2-positive breast cancer. Patients were randomly assigned (1:1) to receive six cycles of either P013 (CinnaGen, Iran) or the originator product (Perjeta, Roche, Switzerland) along with trastuzumab, carboplatin, and docetaxel every 3 weeks. Patients were stratified by cancer type (operable, locally advanced, inflammatory) and hormone receptor status. The primary endpoint was breast pathologic complete response (bpCR). Secondary endpoints included comparisons of total pCR, overall response rate (ORR), breast-conserving surgery (BCS), safety, and immunogenicity. RESULTS: Two hundred fourteen patients were randomized to treatment groups. bpCR rate in the per-protocol population was 67.62% in the P013 and 71.57% in the reference drug groups. Based on bpCR, P013 was equivalent to the reference pertuzumab with a mean difference of - 0.04 (95% CI: - 0.16, 0.09). Secondary endpoints were also comparable between the two groups. CONCLUSIONS: The proposed biosimilar P013 was equivalent to the reference product in terms of efficacy. The safety of both medications was also comparable.


Assuntos
Medicamentos Biossimilares , Neoplasias da Mama , Anticorpos Monoclonais Humanizados/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Neoplasias da Mama/patologia , Feminino , Humanos
3.
Int J Clin Pract ; 2022: 3406783, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36101813

RESUMO

Background: Infliximab (IFX) biosimilar was the first biosimilar approved in Jordan in 2014, with limited evidence of its safety and effectiveness from the Middle East and North Africa (MENA) region. Thus, this study aimed to evaluate the safety and effectiveness of IFX biosimilar in active rheumatoid arthritis (RA) patients over 34 weeks by investigating (1) the adverse events (AEs), serious adverse events (SAEs), and therapy discontinuation and (2) the score changes of the 28-Joint Disease Activity Score (DAS28) and the Health Assessment Questionnaire Disability Index (HAQ-DI). Methods: This multicenter prospective cohort study collected clinical parameters within hospital settings every four weeks. The numbers and percentages of observed AEs and SAEs were informed. The DAS28 utilizing Erythrocyte Sedimentation Rate (ESR), HAQ-DI, and ESR were reported at baseline and 14th and 30th weeks; thus, they were reported as means (SD). Results: A total of 22 RA patients were enrolled and initiated IFX biosimilar, of which nine (41.0%) discontinued the study, but their data were analyzed up to the point of withdrawal. A total of 35 AEs were reported in 14 patients, including two (5.7%) SAEs. None of the participants discontinued treatment due to AEs. The mean (SD) score of DAS28-ESR significantly decreased from 6.55 (1.16) at baseline to 4.59 (1.45) at week 14 (p < 0.0001) and to 4.77 (1.09) at week 30 (p < 0.0001). Similarly, the mean (SD) HAQ-DI score significantly decreased from 0.95 (0.74) at baseline to 0.48 (0.62) at week 14 (p=0.008) and to 0.71 (0.78) at week 30 (p=0.483). The mean (SD) value of ESR decreased from 58.75 (26.94) at baseline to 47.92 (33.89) at week 14 (p=0.082) and to 39.83 (17.38) at week 30 (p=0.005). Conclusion: IFX biosimilar demonstrated safety and effectiveness in managing RA patients bringing real-world clinical support for biosimilars' role in rheumatology.


Assuntos
Antirreumáticos , Artrite Reumatoide , Medicamentos Biossimilares , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/efeitos adversos , Humanos , Infliximab/efeitos adversos , Jordânia , Mitoxantrona/análogos & derivados , Estudos Prospectivos
4.
Drugs Today (Barc) ; 58(9): 457-462, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-36102906

RESUMO

Medicines for Europe held its 2022 annual conference in Sitges, Spain, from June 29 to July 1. Many topics were discussed including future-proofing healthcare systems in the E.U., methods to build a sustainable European ecosystem to incentivize the development of value-added medicines (VAMs), how to reshape national market policies and build a strong European co-operation to prevent shortages. In addition, attendants discussed key challenges and barriers that need to be addressed to ensure the E.U. remains a leader and an innovator in medicines manufacturing, as well as national strategies and practices influencing the sustainability of the biosimilar medicines market and patient access to biological medicines.


Assuntos
Medicamentos Biossimilares , Ecossistema , Comércio , Europa (Continente) , Humanos , Espanha
6.
Drug Des Devel Ther ; 16: 2803-2815, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36043044

RESUMO

After 18 years and the administration of billions of doses, there is little doubt about biosimilars' safety and efficacy. Yet, only 14 molecules in the EU and 9 in the US are available as biosimilars, among the 200+ targets, due mainly to the high development cost attributed to clinical efficacy testing after extensive analytical assessment, nonclinical testing, and clinical pharmacology comparisons. So far, none of the hundreds of clinical efficacy testing has failed because it cannot fail due to its lack of sensitivity for multiple reasons, as argued in this paper. This analysis is unique since biosimilars are the first category of products that are put to comparative testing as if these were new biological drugs. Clinical efficacy testing used to overcome differences in the analytical, nonclinical, and clinical pharmacology comparisons can lead to the approval of unsafe products. Only recently the regulatory agencies have begun to talk about this risk and shown their willingness to waive these studies. However, a clear change in the regulatory guidelines is required to change the mindset of all biosimilar stakeholders to bring a pivotal change in the availability of affordable biosimilars.


Assuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/farmacologia , Aprovação de Drogas , Resultado do Tratamento
7.
Am J Clin Dermatol ; 23(5): 719-728, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35934770

RESUMO

BACKGROUND: BI 695501 is an FDA-approved biosimilar to adalimumab reference product (RP). VOLTAIRE-X was a randomized clinical trial to assess outcomes with a biosimilar monoclonal antibody in line with the FDA requirements for designation as an 'interchangeable' biosimilar. OBJECTIVE: The aim of this study was to assess whether multiple switches between adalimumab RP and BI 695501 lead to equivalent pharmacokinetics and a similar safety and immunogenicity profile compared with continuous adalimumab RP. METHODS: We conducted a phase III, double-blind, randomized controlled trial between July 19, 2017, and April 16, 2019. There were 49 investigational sites across Europe and North America. Of 323 screened patients with moderate-to-severe chronic plaque psoriasis, 259 were treated with adalimumab RP during the run-in period. Of these, 118 and 120 were randomized to the continuous or switching arms, respectively. Interventions consisted of a run-in period with adalimumab RP 80 mg subcutaneously (SC) on Day 1, then 40 mg SC every other week (EOW) Weeks 2-12. Patients were then randomized to receive adalimumab RP 40 mg EOW Weeks 14-48 (continuous arm) or BI 695501 40 mg Weeks 14 and 16, adalimumab RP 40 mg Weeks 18 and 20, and BI 695501 40 mg EOW Weeks 22 to 48 (switching arm); all interventions were given SC. Primary endpoints were pharmacokinetics parameters, area under the plasma concentration-time curve (AUCτ,30-32) and maximum observed drug plasma concentration (Cmax,30-32), measured after the third switch during the Week 30-32 dosing interval. RESULTS: 238 patients (mean [standard deviation] age 44.9 [13.8]; 66.0% male) were treated in the switching (n = 118) or continuous arms (n = 120). Adjusted mean Cmax,30-32 was 7.08 and 7.00 µg/mL in the switching and continuous treatment arms, respectively; adjusted mean AUCτ,30-32 was 2025.8 and 1925.9 µg h/mL. Point estimate for mean ratio for AUCτ,30-32 was 105.2% (90.2% confidence interval [CI] 96.6-114.6), and 101.1% (90.2% CI 93.3-109.7) for Cmax,30-32. Both CIs were within a predefined bioequivalence range of 80.0-125.0%. Treatment-emergent adverse events led to discontinuation in 0.8% and 1.7% of patients in the switching and continuous treatment arms, and Psoriasis Area and Severity Index (PASI) scores were highly similar in the two arms across the entire trial period. CONCLUSIONS: Pharmacokinetic equivalence was demonstrated, with highly similar efficacy and immunogenicity, and comparable safety observed in patients with chronic plaque psoriasis who received either adalimumab RP continuously or who switched between adalimumab RP and BI 695501. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03210259 (registered July 2017); Eudract.ema.europa.eu: 2016-002254-20.


Assuntos
Medicamentos Biossimilares , Doença Enxerto-Hospedeiro , Psoríase , Adalimumab/efeitos adversos , Adulto , Medicamentos Biossimilares/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Equivalência Terapêutica , Resultado do Tratamento
9.
Artigo em Inglês | MEDLINE | ID: mdl-35988497

RESUMO

Biopharmaceuticals, such as monoclonal antibodies, are considered as life-saving drugs for autoimmune diseases, cancer and infectious diseases. However, biotherapeutics tend to undergo chemical degradation during various stages of manufacturing. The conditions of chemical degradation, along with the physical degradation pathways, have a direct influence on the overall stability, safety and efficacy of these therapeutics. While site-specific chemical changes have been well-explored and investigated using various analytical approaches, the resulting conformational and structural changes have not been much studied. Thus, we explored various biophysical techniques for assessing the influence of three representatives forced degradation conditions viz. oxidation, deamidation, and glycation, in a model therapeutic trastuzumab biosimilar. The site-specific modifications caused by these stress conditions were analysed using high resolution mass spectrometry. While their thermodynamic and conformational consequences were investigated by using differential scanning colorimetry (Nano-DSC), circular dichroism (CD) spectroscopy, analytical ultracentrifugation (AUC), and dynamic light scattering (DLS). The investigated stress conditions resulted in reduced thermodynamic stability of mAb, as confirmed using Nano-DSC. Secondary structure analysis performed with CD spectroscopy indicated detectable structural alterations in the beta sheets of stressed samples. DLS and SV-AUC studies demonstrated an enhanced level of aggregation and fragmentation in presence of all stress conditions. Thus, the biophysical analytical toolkits, when used simultaneously, could offer deeper insights into the subtle conformational changes that result from site-specific chemical modifications in mAbs. Hence, these analytical approaches may serve as significant additions to the battery of techniques used for forced degradation analysis of biopharmaceuticals.


Assuntos
Medicamentos Biossimilares , Aminoácidos/química , Anticorpos Monoclonais/química , Medicamentos Biossimilares/química , Difusão Dinâmica da Luz , Trastuzumab
10.
J Pharm Biomed Anal ; 220: 115004, 2022 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-35988306

RESUMO

A recombinant humanized monoclonal antibody (mAb) Eculizumab, C5-complement cascade inhibitor, is an important treatment of complement-based diseases recommended by international guidelines. Elizaria® Drug Product (DP), developed by IBC Generium, Russia, is the world's first registered biosimilar of eculizumab (Soliris®, Alexion Pharmaceuticals). Using sensitive state-of-the-art analytical techniques extensive similarity assessment has been conducted to demonstrate the structural and functional similarity of original Soliris® (Eculizumab Reference Product, RP) and the biosimilar Elizaria®, focusing on the physicochemical and biological quality attributes, including those known to affect the mechanisms of action. A multitude of analyses revealed that amino acid sequence is identical, the higher order structures, post-translational modifications, purity, and product variants are highly similar between Elizaria® DP and Eculizumab RP, except for minor differences in the relative abundance of the charge variants and glycan moieties considered not clinically significant. The results demonstrate that Elizaria® is highly analytically similar to Eculizumab RP in terms of physicochemical properties and biological activities.


Assuntos
Medicamentos Biossimilares , Hemoglobinúria Paroxística , Anticorpos Monoclonais Humanizados/uso terapêutico , Medicamentos Biossimilares/química , Inativadores do Complemento , Hemoglobinúria Paroxística/tratamento farmacológico , Humanos , Preparações Farmacêuticas
11.
PLoS One ; 17(8): e0271299, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35939424

RESUMO

OBJECTIVE: The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. MATERIAL AND METHODS: Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn's disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn's Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. RESULTS: In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. CONCLUSIONS: This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.


Assuntos
Medicamentos Biossimilares , Colite Ulcerativa , Doença de Crohn , Doenças Inflamatórias Intestinais , Adalimumab/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Estudos Prospectivos , Indução de Remissão , Resultado do Tratamento
12.
Expert Opin Drug Metab Toxicol ; 18(7-8): 519-527, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35961948

RESUMO

BACKGROUND: Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males. RESEARCH DESIGN & METHOD: Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study. RESULTS: The geometric mean ratios (GMRs) of AUC0-t, Cmax, and AUC0-∞ for bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial. CONCLUSION: This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.


Assuntos
Medicamentos Biossimilares , Área Sob a Curva , Bevacizumab/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , China , Método Duplo-Cego , Voluntários Saudáveis , Humanos , Masculino , Equivalência Terapêutica
13.
Drugs R D ; 22(3): 225-234, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35933639

RESUMO

AIM: The purpose of this study was to evaluate the extended physicochemical and biological stability of Sandoz Rixathon®/Riximyo® (SDZ-RTX) after exposure to out-of-fridge (OOF) conditions. MATERIALS AND METHODS: The impact of the short-term temperature excursion on stability parameters of SDZ-RTX was simulated by subsequently exposing the three batches of SDZ-RTX (100 and 500 mg) to OOF conditions, (I) 25 ± 2 °C/60 ± 5% relative humidity (RH) and (II) 30 ± 2 °C/65 ± 5% RH, for up to 21 days after more than the claimed 36-month shelf-life storage in long-term conditions (5 ± 3 °C). Analytical methods used included the cation exchange chromatography (CEX), size exclusion chromatography (SEC), and non-reducing capillary electrophoresis-sodium dodecyl sulfate (nrCE-SDS), as well as biological activity by complement-dependent cytotoxicity (CDC)-bioactivity as well as further methods, for example, related to identity and pharmacopoeia test methods. RESULTS: No notable changes were observed across all batches with respect to identity (charge and primary structure), pharmaceutical tests (clarity, visible and subvisible particles analytics, container appearance, degree of coloration, pH, osmolality, extractable volume, and container closure integrity testing), protein content by UV and microbiological parameters (sterility and bacterial endotoxins) under both OOF conditions. Only minor changes were observed for parameters evaluated via SEC, CEX, and nrCE-SDS. For potency (CDC-bioactivity) only one of the batches showed a relevant change. Even for these stability-indicating test methods, all analyzed parameters complied with the shelf-life specifications. CONCLUSION: SDZ-RTX is safe for use even under worst-case conditions, for example, after subjecting it for up to 21 days at OOF conditions (25 ± 2 °C/60 ± 5% RH or 30 ± 2 °C/65 ± 5% RH) after the batches had reached an age that was already beyond the claimed shelf-life.


Assuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/química , Estabilidade de Medicamentos , Humanos , Rituximab/química , Temperatura
14.
Expert Rev Clin Pharmacol ; 15(7): 851-861, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35980222

RESUMO

INTRODUCTION: Paroxysmal nocturnal hemoglobinuria (PNH) is characterized by uncontrolled activation of the terminal complement pathway, leading to intravascular hemolysis (IVH) and a prothrombotic state. Treatment with terminal complement (C5) inhibitors, the current standard of care, suppresses IVH and reduces the risk of thrombosis and the associated morbidity and mortality. Opportunities exist to further improve care by alternative modes of administration and the reduction of clinically significant anemia and transfusion dependence caused by extravascular hemolysis in some patients. AREAS COVERED: This review describes the pathophysiology of PNH, provides an overview of the current standard of care, and discusses potential avenues for enhancing patient care, with a focus on the literature describing new and emerging treatments that target the alternative pathway. Emerging treatments include biosimilars and novel C5 inhibitors as well as agents with novel mechanisms of action that target the proximal complement pathways (C3 inhibitors, factor B inhibitors, and factor D inhibitors). EXPERT OPINION: Alternative complement pathway inhibitors may offer further benefit as long as terminal complement is completely inhibited to reduce IVH and disease activity. This may lead to improvements in adherence and health-related quality of life for patients with PNH.


Assuntos
Medicamentos Biossimilares , Hemoglobinúria Paroxística , Anticorpos Monoclonais Humanizados/farmacologia , Anticorpos Monoclonais Humanizados/uso terapêutico , Complemento C3/metabolismo , Complemento C5 , Hemoglobinúria Paroxística/tratamento farmacológico , Hemoglobinúria Paroxística/etiologia , Hemólise , Humanos , Qualidade de Vida
15.
Artigo em Inglês | MEDLINE | ID: mdl-36011946

RESUMO

INTRODUCTION: The increasing availability of biosimilars can increase patient access to these drugs and reduce the economic burden. Nurses play a key role in the education, administration, pharmacovigilance and management of the side effects of biosimilars. The aim of this study was to assess the knowledge and attitudes of nurses towards biosimilar drugs in different countries. METHODS: An international cross-sectional study was conducted from November 2021 to February 2022. The survey was carried out using Computer-Assisted Web Interview (CAWI), sent by the CAWI panel via the website. RESULTS: The results showed that nurses with a greater level of education felt most knowledgeable about biosimilars (χ2 = 105.813, df = 2, p < 0.001). One-third of nurses with a doctorate and a second degree said biosimilars are used in their workplace (χ2 = 48.169, df = 4, p < 0.001); most nurses with a second degree said that they had never heard of biosimilars (41%). Doctorate-level nurses thought knowledge is the key factor to increasing biosimilar uptake (97%). CONCLUSIONS: Nurses are not knowledgeable about biosimilars. Most would like to participate in training on biosimilars. This is a very important topic, because biosimilars are constantly evolving in medicine.


Assuntos
Medicamentos Biossimilares , Enfermeiras e Enfermeiros , Competência Clínica , Estudos Transversais , Enfermagem Baseada em Evidências , Humanos , Farmacêuticos , Projetos Piloto
16.
BioDrugs ; 36(5): 639-644, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35960446

RESUMO

BACKGROUND: Despite growing awareness of the nocebo effect, few studies have evaluated the nocebo effect using combined assessment of patient-reported outcome measures (PROMs), clinical indices, and objective biomarkers in inflammatory bowel disease (IBD) patients switching from originator to biosimilar medicines. OBJECTIVE: This study aimed to compare these outcomes across switch and non-switch cohorts to evaluate the nocebo effect in patients with IBD. METHODS: Parallel cohorts of IBD patients who (1) switched from originator to biosimilar (CT-P13) infliximab and (2) continued biosimilar (CT-P13) infliximab were evaluated over 32 weeks. Clinical disease activity, objective biomarkers and PROMs were assessed at baseline, and weeks 16 and 32 across both cohorts. The PROM of interest was patient-perceived disease activity evaluated using a 0-100 visual analogue scale (VAS) per the IBD-Control Questionnaire. RESULTS: Of 81 patients, 47 switched from originator to biosimilar (CT-P13) infliximab. A negative change from baseline patient-reported disease control was observed across the switch cohort compared with the non-switch cohort at week 16 (mean VAS - 8.21 vs. 1.26; p = 0.03), but not at week 32 (mean VAS - 1.21 vs. 1.38; p = 0.58). Corresponding clinical and objective biomarker assessments over these timepoints were comparable across both cohorts. CONCLUSION: This study demonstrated a temporary yet discernible nocebo effect in the first 16 weeks following non-medical switching that was not sustained at week 32. Negative patient perceptions may be overcome by a patient-inclusive approach to non-medical switching in conjunction with close clinical follow-up and disease monitoring.


Assuntos
Medicamentos Biossimilares , Doença de Crohn , Doenças Inflamatórias Intestinais , Biomarcadores , Medicamentos Biossimilares/uso terapêutico , Doença Crônica , Doença de Crohn/tratamento farmacológico , Substituição de Medicamentos , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/uso terapêutico , Efeito Nocebo , Resultado do Tratamento
17.
BioDrugs ; 36(5): 645-655, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35962911

RESUMO

BACKGROUND: Biosimilars account for 30-40% of biologic medications dispensed in the United States (US), yet healthcare providers in relevant medical specialties have limited awareness of biosimilars and their characteristics. Likewise, many providers perceive biosimilars as less safe and effective than original biologics and are more comfortable prescribing original biologics to patients. METHODS: We conducted in-person focus groups at three clinical sites in California and Texas (n = 49) to explore the reasons behind US healthcare providers' limited understanding of, cautious attitudes toward, and reluctance to prescribe biosimilars. We conducted thematic analysis by having three researchers independently analyze verbatim transcripts and identify patterns in provider responses. RESULTS: Providers' limited knowledge of and cautious attitudes toward biosimilars are driven by uncertainty about how biosimilarity is defined and operationalized as well as negative past experiences with generic drugs that did not perform as well as branded counterparts. Additionally, healthcare providers are unfamiliar with the Food and Drug Administration's (FDA's) approval pathway for biosimilars and are skeptical that an abbreviated approval process is rigorous enough to ensure biosimilars deliver the same efficacy and have the same side effect profiles as original biologics. Physicians also expressed concerns about pharmacy substitution of biosimilars and interchangeables, explaining they would be unaware of which medication was ultimately given to their patients. CONCLUSIONS: Educating physicians and pharmacists about biosimilars-including how biosimilarity is defined and operationalized, the structure of the biosimilar approval process, and how analytical data can ensure biosimilar safety and efficacy-will be important for reducing healthcare providers' concerns and increasing biosimilar adoption in the US.


Assuntos
Medicamentos Biossimilares , Médicos , Medicamentos Biossimilares/uso terapêutico , Aprovação de Drogas , Medicamentos Genéricos , Humanos , Farmacêuticos , Estados Unidos , United States Food and Drug Administration
18.
Am J Manag Care ; 28(7): 329-335, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35852882

RESUMO

OBJECTIVES: Biologics account for an increasing share of US prescription drug spending. Biosimilars could lower biologic prices through competition, but barriers to increasing both supply and uptake remain. We projected US biosimilar savings from 2021 to 2025 under different scenarios. STUDY DESIGN: We projected US spending on biologics over a 5-year period under 3 scenarios: (1) a baseline scenario holding quarter 4 (Q4) of 2020 market conditions constant; (2) under main assumptions allowing for biosimilar market growth and entry; and (3) an upper-bound scenario assuming greater biosimilar uptake, more robust price competition, and quicker biosimilar entry. METHODS: We first analyzed 2014-2020 US volume and price data from IQVIA's MIDAS database for biologics already facing biosimilar competition to inform model parameter values. We used these inputs to project biosimilar entry, biosimilar volume shares, biosimilar prices, and reference biologic prices. We calculated 2021-2025 new savings from biosimilar competition vs the Q4 2020 baseline. RESULTS: Estimated biosimilar savings from 2021 to 2025 under our main approach were $38.4 billion, or 5.9% of projected spending on biologics over the same period. Biologics first facing biosimilar competition from 2021 to 2025 accounted for $26.1 billion of savings, with $12.2 billion from evolving market conditions for already-marketed biosimilars. Furthermore, $24.6 billion of savings under our main approach were from downward pressure on reference biologic prices rather than lower biosimilar prices. Savings were substantially higher ($124.5 billion) under the upper-bound scenario. CONCLUSIONS: Biosimilar savings from 2021 to 2025 were $38.4 billion under our main assumptions. Greater savings may be feasible if managed care and other settings increase biosimilar utilization and promote competition.


Assuntos
Medicamentos Biossimilares , Previsões , Humanos , Programas de Assistência Gerenciada
19.
Int J Clin Pract ; 2022: 8080308, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35832802

RESUMO

Aims: Pharmacists in all clinical settings are recognized drug experts and integral educators of biosimilar medicines. Therefore, the objective of this study was to assess pharmacists' knowledge, predictors of knowledge, and views toward biosimilar medicines in Jordan. Methods: A cross-sectional study was conducted in Jordan during October-December 2020. An Internet-based self-administrated questionnaire on knowledge and views was distributed using social media groups to the pharmacists among different areas in Jordan. A descriptive and univariate analysis was performed. Binary logistic regression was conducted to determine the predictors of knowledge including all variables with p < 0.20 on univariate analysis. Results: A total 536 responses were received, 502 of which were completed (93.7% response rate). A total of 52.6% of the pharmacists were knowledgeable about biosimilar medicines and the mean of knowledge level was 6.47 ± 1.62 (range 2-10). Multivariate analysis identified that respondents who had heard about biosimilars before (OR = 1.942, 95% CI = 1.231-3.063, p < 0.05) was more likely to be knowledgeable. Respondents who had not taken the course or the postgraduating training course about biosimilars that were less likely to be knowledgeable (OR = 0.548, 95% CI = 0.357-0.839, p < 0.05). A positive response was noted in pharmacist's view regarding the implementation of biosimilar medicines in healthcare setting, biosimilar medicine prescription related to decreased costs, self-study about biosimilar medicine, and incorporating biosimilar education program at the pharmacy school curriculum universities level. Conclusions: Pharmacists' views and knowledge vary regarding the particularities and key issues on biosimilar medicines in Jordan. Incorporating biosimilar course in pharmacy school curriculum could improve their acceptance for future pharmacy jobs.


Assuntos
Medicamentos Biossimilares , Farmacêuticos , Medicamentos Biossimilares/uso terapêutico , Estudos Transversais , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Jordânia , Inquéritos e Questionários
20.
BioDrugs ; 36(4): 489-508, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35776294

RESUMO

BACKGROUND AND OBJECTIVE: While biosimilars are less expensive than their originator biologics, various factors are known to impede their uptake in clinical practice including concerns regarding their interchangeability, efficacy, and safety. Pharmacists are well positioned to promote the adoption of biosimilars, thus, the aim of the review was to assess pharmacists' knowledge and perceptions of biosimilars to identify the need for pharmacist-directed biosimilar education. METHODS: We conducted a systematic literature search for published articles indexed in MEDLINE via EBSCOHOST, Web of Science, Scopus, Cochrane Library, Dimensions, and Google Scholar databases. We included studies written in English from their earliest publication dates until December 2021. Only studies concerning pharmacists' perspectives on biosimilars were included. Two reviewers extracted data from the studies that included pharmacists' knowledge, perceptions, and opinions about interchangeability and automatic substitution of biosimilars. We also assessed the methodological quality of the included studies using the Joanna Briggs Institute Analytical Cross-Sectional Studies Assessment (JBI-ACSSA) for quantitative studies and the Critical Appraisal Skills Programme (CASP) for qualitative studies. RESULTS: Out of the 22 studies included in the review, 19 were cross-sectional quantitative studies, and the other three were qualitative studies. The sample size of the included studies ranged from 19 to 1500 participants. The level of knowledge of biosimilars graded as good, considerable, above average, or excellent among pharmacists varied from study to study, with a range of 47-86%. Only 22-51% of pharmacists were comfortable if biosimilars were prescribed for all of the indications previously used for the originator products. Pharmacists' acceptability of switching from the originator to a biosimilar also varied, with a range of 26-84%. However, most pharmacists viewed the substitution of the originator with a biosimilar without physicians' permission as unacceptable. Data from three studies reported that 22-74% of pharmacists had attended biosimilar training. They obtained information about biosimilars from scientific publications, pharmaceutical companies, and continuing education. Based on the criteria of JBI-ACSSA and CASP, the overall methodological quality of the studies ranged from moderate to high. The majority of the studies did not describe the sampling methods used and the strategies to deal with confounding factors. CONCLUSIONS: Pharmacists' knowledge and perception about biosimilars varied and were limited, especially about interchangeability and substitution, efficacy, safety, and indication extrapolation. A better understanding of biosimilars amongst pharmacists could help them to encourage prescribers' acceptance of biosimilars.


Assuntos
Medicamentos Biossimilares , Medicamentos Biossimilares/uso terapêutico , Humanos , Farmacêuticos
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