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1.
J Law Med ; 29(1): 208-223, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35362289

ABSTRACT

Biosimilar medicines have the potential to increase medicine access and bring cost savings to consumers, but uptake has been slow for a range of reasons. This article analyses one such reason, namely the potential for competitors' promotional materials to use certain terms with technical meanings, such as "interchangeable" and "substitution", in a misleading way. Against the backdrop of a flawed co-regulatory system for pharmaceutical marketing, the article identifies a need for clear regulatory statements about appropriate uses of such terms in pharmaceutical marketing and promotion.


Subject(s)
Biosimilar Pharmaceuticals , Marketing , Mouth , Plastics
2.
Front Public Health ; 10: 944071, 2022.
Article in English | MEDLINE | ID: mdl-36159303

ABSTRACT

Background: Human epidermal growth factor receptor 2 (HER2) inhibitors have been approved to treat various cancers with HER2 amplification. The Chinese government has made great efforts to improve the availability and affordability of these drugs. This study aimed to analyze the trends in anti-HER2 drug consumptions in Nanjing from 2012 to 2021, and explore influencing factors. Methods: Data about use of anti-HER2 drugs in 2012-2021 were extracted from Jiangsu Medicine Information Institute. Six types of anti-HER2 drugs were included. Drug consumption was expressed as defined daily doses (DDDs) and expenditure. Time series analysis was adopted to find trends in consumption, while interrupted time series was used in analyzing the impact of policy on consumption. The correlation between DDDs and defined daily cost (DDC) was analyzed by Pearson's correlation test. Results: The DDC, DDDs, and expenditure of anti-HER2 drugs changed little from 2012 to 2016. The DDC decreased intermittently, while the DDDs and expenditure of these drugs grew continuously from 2017 to 2021. The anti-HER2 monoclonal antibodies contributed to the majority of total consumption in 2012-2019. The DDDs of anti-HER2 tyrosine kinase inhibitors surpassed the DDDs of monoclonal antibodies in 2020-2021. Trastuzumab was the predominantly prescribed drug in 2012-2019, but the DDDs of pyrotinib surpassed the DDDs of trastuzumab in 2020-2021. The ln value of DDC or self-paid DDC of trastuzumab was negatively correlated with the ln value of its DDDs. The national health insurance coverage (NHIC) and national drug price negotiation policy about anti-HER2 drugs were initiated in 2017. Low-price generics and biosimilar of trastuzumab came into the market in 2020 and 2021, separately. Interrupted time series analysis showed that the DDDs increased significantly after the implementation of NHIC, price negotiation or generic drug replacement. Conclusion: The consumption of anti-HER2 drugs has significantly increased and their DDC has decreased after the implementation of NHIC, price negotiation, or low-price generic drug replacement since 2017. Further efforts are needed to translate the high consumption into clinical benefits.


Subject(s)
Biosimilar Pharmaceuticals , Drugs, Generic , Drugs, Generic/therapeutic use , Humans , Protein Kinase Inhibitors , Receptor, ErbB-2 , Trastuzumab/therapeutic use
3.
Acta Med Indones ; 54(3): 397-405, 2022 Jul.
Article in English | MEDLINE | ID: mdl-36156480

ABSTRACT

BACKGROUND: Anemia due to chronic kidney disease (CKD) is often associated with decreased erythropoietin (EPO) levels in the blood. Treatments available are improving blood iron levels and administration of exogenous EPO (rhEPO). This study aims to assess the safety and immunogenicity of Epodion, a biosimilar rhEPO product, in haemodialysis patients with CKD-associated anaemia in three Indonesian hospitals. METHODS: This prospective, open label, single arm, and multicenter study enrolled patients with anemia associated with CKD under hemodialysis treatment. Patient eligibility was assessed within the 4-week screening period. Blood samples for determination of erythropoietin antibody (Anti-Drug Antibody) were taken at week-0, 24, and 52 using a validated and highly sensitive bridging ELISA method. Evaluation of Neutralizing Antibody (NAb) was carried out to confirm the impact of the antibody to pharmacological activity (e.g., antibody-mediated PRCA) when the ADA detection of patients was positive after screening and confirmatory assay. RESULTS: Results from all tested patients show that Epodion could maintain hemoglobin and hematocrit levels. ADA detection using ELISA assay yielded negative results for all plasma samples of week-24 and week-52, so the evaluation of NAb was not carried out. No adverse events were considered relevant to tested product. CONCLUSION: This study proves no immunogenic effect of Epodion on stimulating immune system's antibodies in Indonesian patients with CKD-associated anemia.


Subject(s)
Anemia , Biosimilar Pharmaceuticals , Erythropoietin , Renal Insufficiency, Chronic , Anemia/drug therapy , Anemia/etiology , Antibodies, Neutralizing/therapeutic use , Epoetin Alfa/therapeutic use , Erythropoietin/therapeutic use , Hemoglobins/analysis , Humans , Iron/therapeutic use , Prospective Studies , Renal Dialysis/adverse effects , Renal Insufficiency, Chronic/drug therapy , Renal Insufficiency, Chronic/therapy
4.
Int J Mol Sci ; 23(18)2022 Sep 14.
Article in English | MEDLINE | ID: mdl-36142600

ABSTRACT

Scientific, technical, and bioinformatics advances have made it possible to establish analytics-based molecular biosimilarity for the approval of biosimilars. If the molecular structure is identical and other product- and process-related attributes are comparable within the testing limits, then a biosimilar candidate will have the same safety and efficacy as its reference product. Classical testing in animals and patients is much less sensitive in terms of identifying clinically meaningful differences, as is reported in the literature. The recent artificial intelligence (AI)-based protein structure prediction model, AlphaFold-2, has confirmed that the primary structure of proteins always determines their 3D structure; thus, we can deduce that a biosimilar with an identical primary structure will have the same efficacy and safety. Further confirmation of the thesis has been established using technologies that are now much more sensitive. For example, mass spectrometry (MS) is thousands of times more sensitive and accurate when compared to any form of biological testing. While regulatory agencies have begun waiving animal testing and, in some cases, clinical efficacy testing, the removal of clinical pharmacology profiling brings with it a dramatic paradigm shift, reducing development costs without compromising safety or efficacy. A list of 160+ products that are ready to enter as biosimilars has been shared. Major actions from regulatory agencies and developers are required to facilitate this paradigm shift.


Subject(s)
Biosimilar Pharmaceuticals , Animals , Artificial Intelligence , Biosimilar Pharmaceuticals/pharmacology , Government Agencies
5.
Int J Clin Pract ; 2022: 3406783, 2022.
Article in English | MEDLINE | ID: mdl-36101813

ABSTRACT

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.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/adverse effects , Humans , Infliximab/adverse effects , Jordan , Mitoxantrone/analogs & derivatives , Prospective Studies
6.
Drugs Today (Barc) ; 58(9): 457-462, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36102906

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Ecosystem , Commerce , Europe , Humans , Spain
7.
BMC Cancer ; 22(1): 960, 2022 Sep 07.
Article in English | MEDLINE | ID: mdl-36071409

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Breast Neoplasms , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Breast Neoplasms/pathology , Female , Humans
8.
Immunotherapy ; 14(15): 1183-1190, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36065786

ABSTRACT

WHAT IS THIS SUMMARY ABOUT?: Here, we summarize the results from the VOLTAIRE-RA study, originally published in the journal Annals of the Rheumatic Diseases. The VOLTAIRE-RA study looked at how effective and safe BI 695501 is in treating people with rheumatoid arthritis (also known as RA). BI 695501 is a biosimilar whose reference product is adalimumab (known by the brand name Humira). A biosimilar is one that is made to be very similar to, and less expensive than the original biologic, also known as the reference product. The VOLTAIRE-RA study aimed to show that BI 695501 is as effective and safe as Humira in treating people with moderate-to-severe RA. WHAT WERE THE RESULTS?: Participants of the VOLTAIRE-RA study took either Humira for 24 weeks and then switched to taking BI 695501 for a further 24 weeks, or BI 695501 for 48 weeks. The participants treated with BI 695501 and Humira had very similar outcomes in terms of reducing symptoms, as well as experiencing side effects. This was also seen for those participants who switched from taking Humira to BI 695501. WHAT DO THE RESULTS MEAN?: These results show that both Humira and BI 695501 could be used to treat people with RA as very similar treatment outcomes could be expected. Clinical Trial Registration: NCT02137226 (ClinicalTrials.gov).


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Adalimumab/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Biosimilar Pharmaceuticals/therapeutic use , Double-Blind Method , Humans , Language
9.
Drug Des Devel Ther ; 16: 2803-2815, 2022.
Article in English | MEDLINE | ID: mdl-36043044

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Biosimilar Pharmaceuticals/pharmacology , Drug Approval , Treatment Outcome
11.
Int J Environ Res Public Health ; 19(16)2022 08 19.
Article in English | MEDLINE | ID: mdl-36011946

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Nurses , Clinical Competence , Cross-Sectional Studies , Evidence-Based Nursing , Humans , Pharmacists , Pilot Projects
12.
Chem Biol Interact ; 366: 110116, 2022 Oct 01.
Article in English | MEDLINE | ID: mdl-36007632

ABSTRACT

Many biologic drug products, particularly monoclonal antibodies (mAbs), were off-patented between 2015 and 2020, and this process is continuing as the number of biologics approvals has increased. However, the availability of affordable biosimilars is delayed by secondary patents related to the formulation and manufacturing process. Therefore, an alternative formulation development is required to avoid infringement of formulation related patents. Several variables must be considered while developing alternative non-infringement formulations, including the time gap between the expiration of the molecule patent and the formulation patent, the ability not to infringe other secondary patents (process-related), and project timelines. As a part of life cycle management, innovator companies are adopting multiple strategies to delay biosimilar competition. Biosimilar companies could use the innovator formulation knowledge space to develop alternative formulations at the expense of time and cost. The present review discusses the key approaches in biosimilar formulation development, and further summarizes the use of innovator formulation knowledge space for biosimilar mAbs product development.


Subject(s)
Biosimilar Pharmaceuticals , Antibodies, Monoclonal/therapeutic use , Drug Approval
13.
J Chromatogr B Analyt Technol Biomed Life Sci ; 1209: 123430, 2022 Oct 15.
Article in English | MEDLINE | ID: mdl-35988497

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Amino Acids/chemistry , Antibodies, Monoclonal/chemistry , Biosimilar Pharmaceuticals/chemistry , Dynamic Light Scattering , Trastuzumab
14.
J Pharm Biomed Anal ; 220: 115004, 2022 Oct 25.
Article in English | MEDLINE | ID: mdl-35988306

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Hemoglobinuria, Paroxysmal , Antibodies, Monoclonal, Humanized/therapeutic use , Biosimilar Pharmaceuticals/chemistry , Complement Inactivating Agents , Hemoglobinuria, Paroxysmal/drug therapy , Humans , Pharmaceutical Preparations
15.
Expert Rev Clin Pharmacol ; 15(7): 851-861, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35980222

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Hemoglobinuria, Paroxysmal , Antibodies, Monoclonal, Humanized/pharmacology , Antibodies, Monoclonal, Humanized/therapeutic use , Complement C3/metabolism , Complement C5 , Hemoglobinuria, Paroxysmal/drug therapy , Hemoglobinuria, Paroxysmal/etiology , Hemolysis , Humans , Quality of Life
16.
JAMA Health Forum ; 2(9): e212634, 2021 09.
Article in English | MEDLINE | ID: mdl-35977178

ABSTRACT

This cross-sectional study describes changes in annual Medicare Part B spending for biologic drugs after biosimilar entry, focusing on the first 4 products to experience biosimilar competition: filgrastim, infliximab, epoetin alpha, and pegfilgrastim.


Subject(s)
Biosimilar Pharmaceuticals , Medicare Part B , Cross-Sectional Studies , Infliximab , United States
17.
J Med Econ ; 25(1): 1118-1126, 2022.
Article in English | MEDLINE | ID: mdl-35965481

ABSTRACT

OBJECTIVE: To model changes in prices, utilization, and expenditures of targeted immune modulators (TIMs) for rheumatoid arthritis, accounting for biosimilar entry. METHODS: Using IQVIA National Sales Perspective data between 2013 and 2019, we examined sales and expenditures of biologics and non-biological complex molecules, 20 quarters before and after patent exclusivity milestones. We estimated the impact of a molecule's exclusivity milestones and biosimilar entry on prices, using a regression discontinuity design (RDD). We then combined the RDD estimate with historical trends to assess the impact of adalimumab's exclusivity milestones on future TIM expenditures. RESULTS: Changes in average molecule prices were associated largely with biosimilar uptake. For molecules with relatively high biosimilar uptake (>60%), prices fell considerably (-21.2% to -59.3%) one year after exclusivity milestones, whereas molecules with lower biosimilar uptake (<10%) experienced smaller price decreases (-2.4% to -8.4%). Average price reduction at the molecule level after biosimilar entry was not significant (-18.6%; p = .657). When applying the RDD results after adalimumab's exclusivity milestones, its projected share of total TIM market expenditures decreased from 48.0% in 2019 to 26.0% in 2025, whereas expenditures on Janus kinase inhibitors increased from 4.0% to 34.0%. CONCLUSIONS: Biologics facing biosimilar competition may experience price decreases, potentially offering substantial savings to payers, patients, and society, although the magnitude of these estimates depends on biosimilar uptake. Formulary placement, along with manufacturer-payer dynamics, may also play a role in determining the impact on price and market uptake of biosimilars.


Subject(s)
Arthritis, Rheumatoid , Biosimilar Pharmaceuticals , Janus Kinase Inhibitors , Adalimumab/therapeutic use , Arthritis, Rheumatoid/drug therapy , Biological Factors , Biosimilar Pharmaceuticals/therapeutic use , Health Expenditures , Humans
18.
BioDrugs ; 36(5): 645-655, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35962911

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Physicians , Biosimilar Pharmaceuticals/therapeutic use , Drug Approval , Drugs, Generic , Humans , Pharmacists , United States , United States Food and Drug Administration
19.
Expert Opin Drug Metab Toxicol ; 18(7-8): 519-527, 2022.
Article in English | MEDLINE | ID: mdl-35961948

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Area Under Curve , Bevacizumab/adverse effects , Biosimilar Pharmaceuticals/adverse effects , China , Double-Blind Method , Healthy Volunteers , Humans , Male , Therapeutic Equivalency
20.
BioDrugs ; 36(5): 639-644, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35960446

ABSTRACT

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.


Subject(s)
Biosimilar Pharmaceuticals , Crohn Disease , Inflammatory Bowel Diseases , Biomarkers , Biosimilar Pharmaceuticals/therapeutic use , Chronic Disease , Crohn Disease/drug therapy , Drug Substitution , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Nocebo Effect , Treatment Outcome
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