BACKGROUND/RATIONALE:
Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied.
OBJECTIVE:
To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.

开始日期2021-03-11

申办/合作机构

University Medical Center Groningen

[+2]

NCT04610476 / Recruiting临床3期IIT

A Prospective, Randomized, Controlled, Open Label, Assessor-blinded, Parallel-group Phase III Clinical Trial to Evaluate the Impact of Tapering Systemic Immunosuppressive Therapy in a Treat-to-target Approach on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis

The rationale for this study is to investigate whether in psoriatic arthritis (PsA) patients in stable remission a reduction or complete discontinuation of immunosuppressive therapy can be achieved in a treat-to-target approach while maintaining in remission. Due to the lack of reliable data that answers the question of how to safely reduce medication in which patients, this study will test a pragmatic treatment algorithm that can be applied in clinical practice and that offers a gradual reduction with escape strategies in order to facilitate the maintenance of remission.

开始日期2020-10-19

申办/合作机构

Friedrich Alexander Universität Erlangen Nürnberg

NCT03885089 / CompletedN/A

Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Psoriasis Vulgaris, Psoriasis Arthropathica, Pustular Psoriasis, or Erythrodermic Psoriasis)

To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis under actual status of use.

开始日期2019-10-21

申办/合作机构

Pfizer Inc.

100 项与英夫利西单抗生物类似药 (Pfizer) 相关的临床结果

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100 项与英夫利西单抗生物类似药 (Pfizer) 相关的转化医学

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100 项与英夫利西单抗生物类似药 (Pfizer) 相关的专利（医药）

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项与英夫利西单抗生物类似药 (Pfizer) 相关的文献（医药）

2024-01-01·Discovery medicine

Antibody Response after a Booster COVID-19 Vaccine Mixing in Vietnam

Article

作者: Doan, Thien Huu ; Tran, Tram Hong ; Nguyen, Thai Duy ; Pham, Hung Van ; Phung, Toi Lam ; Nguyen, Bach Kim

BACKGROUND:

The booster vaccine is essential for maintaining the antibody against the severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) virus. This study sought to evaluate the antibody response after booster coronavirus disease 2019 (COVID-19) vaccines and compare the immunogenic by different vaccine combination strategies.

METHODS:

A cross-sectional study in Hanoi, Vietnam was conducted on 679 adult participants who received two doses of vaccines with any combination of AstraZeneca, Pfizer, and Moderna during the COVID-19 vaccination campaign in 2021. The SARS-CoV-2 S1/S2 Immunoglobulin G (IgG) antibody concentrations were measured by the LIAISON SARS-CoV-2 S1/S2 IgG and presented as arbitrary units.

RESULTS:

We found that the median (interquartile range (IQR)) of IgG level among those who completed two doses of Moderna and Pfizer was 484.55 (284.80) AU/mL and 349.00 (362.50) AU/mL, respectively. Meanwhile, the counterpart of AstraZeneca was 110.00 (128.10) AU/mL. Mixing two doses of AstraZeneca-Pfizer has higher odds of having high IgG level than two doses of Pfizer (Odds Ratios (OR) = 2.94, 95% Confidence Intervals (CI): 1.57-5.51), AstraZeneca (OR = 28.50, 95% CI: 15.00-54.14).

CONCLUSIONS:

We found that the matching two doses of mRNA vaccines are more immunogenic as compared to the DNA vector vaccines. Furthermore, mixing AstraZeneca-Pfizer has higher antibody quantities as compared to matching vaccines, while lower the rate of advert events.

2023-12-30·Acta neurologica Taiwanica

The Clinical Course of New-Onset Ocular Myasthenia Gravis Caused by Pfizer-BioNTech COVID-19 Vaccine.

Article

作者: Lu, Chien-Jung ; Su, Wei-Yu

PURPOSE:

Myasthenia gravis (MG) caused by COVID-19 vaccine had been reported, but the clinical course of new-onset ocular MG had never been described. We would like to document the clinical course of a patient with new-onset ocular MG which was caused by Pfizer-BioNTech COVID-19 vaccine.

CASE REPORT:

A 39-year-old woman noticed diplopia one week after she accepted the first dose of Pfizer- BioNTech COVID-19 vaccine. Diagnosis of ocular MG was made after investigation. Despite intravenous immunoglobulins, pyridostigmine and prednisolone therapy, she had no improvement until 10 days after treatment. She then rapidly improved, and almost fully recovered in the following 10 days. We had observed this patient for 8 months. After tapering off steroid, she remained stable to date, though she still suffered from transient diplopia on awakening.

CONCLUSION:

No matter the symptoms at onset, the clinical course or the response to steroid therapy was identical to ocular MG that we had ever known. Ocular MG caused by COVID-19 vaccine could probably be an iatrogenic life-long disease.

2023-12-01·Current microbiology

Comparative Analysis of IgG Antibody Titers Induced by Three Different SARS-COV-2 Vaccines in Healthy Adults of Pakistan

Article

作者: Rizvi, Nayab Batool ; Rana, Muhammad Zeeshan ; Khan, Qaiser Alam ; Shahid, Muhammad ; Zaffar, Sehrish ; Farooq, Hassam ; Hussain, Nazim

Covid-19 is a contagious disease caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). In order to control this disease, different effective vaccines have been developed. This study is an attempt to determine the strength and duration of immunogenicity of various established vaccines. This cross-sectional, observational study was conducted to compare the efficacy of three different vaccines; Pfizer BNT 162b2, Sinovac, and CanSino, respectively, after a duration of 3 months, in the healthy adult population of Pakistan. In this study 371 healthy participants (aged 12-25 years) of both genders (male and females) were enrolled. The blood sample was drawn 90 days after the complete vaccination process. The humoral response (IgG) was analyzed by electrochemiluminescence immunoassay (ECLIA) method with Roche Anti-SARS-CoV-2 S analyzer kit. Descriptive statistical analysis was performed using IBM SPSS statistics version 22 and P < 0.05 was considered significant. The mean antibody titer in Pfizer-group was 12,536.35 U/mL, followed by 5168.68 U/mL in the Sinovac group and 4284.32 U/mL in the CanSino group. The Pfizer-group showed gender-specific significant differences, with higher antibody levels in males (P = 0.006) as compared to Sinovac and Cansino groups. The Mean IgG antibody levels of the Pfizer-vaccinated group were significantly higher than the Sinovac-vaccinated group and the CanSino-vaccinated group (P = 0.000, each). However, the mean difference between the Sinovac-vaccinated group and the CanSino-vaccinated group was not significant. Vaccine-induced seropositivity was found in the whole cohort. The mRNA-based vaccine produced the highest immune response, and thus, it is recommended for future application.

项与英夫利西单抗生物类似药 (Pfizer) 相关的新闻（医药）

2024-03-14

·PRNewswire

Psoriasis in America - Insights into Psoriasis Patient Demographics, Quality of Life, Information-seeking Behaviors, HCP Engagement and Treatment Experiences

DUBLIN, March 14, 2024 /PRNewswire/ -- The "Psoriasis in America 2023: Understanding the Psoriasis Patient Experience" report has been added to ResearchAndMarkets.com's offering. Approximately 7.5 million people in the United States have psoriasis. This Psoriasis in America report provides a comprehensive look at life for those living with psoriasis. Using detailed quantitative data, it gives a full picture of the psoriasis patient experience - from symptoms to treatment to HCP relationships to quality of life - so you can make informed, strategic decisions, identify opportunities, and understand potential challenges. The report offers an in-depth look at the psoriasis patient experience. This large-scale, patient-reported data leverages vital quantitative insights essential to understanding key touchpoints in the psoriasis patient journey, including condition management, HCP engagement, quality of life, treatment experience and satisfaction, and much more. This report lifts the curtain on life with psoriasis, giving stakeholders an actionable look at the behaviors, attitudes, perceptions, needs, and experiences of people living with the condition. Data can be used to inform strategic decisions, including product communications, competitive assessments, concept development, landscape analyses, patient journey overlays, and forecasting inputs. This report also addresses important questions that stakeholders may not even know to ask while offering valuable insights into must-have patient-reported data points not available anywhere else. Add-on custom data analysis opportunities are also available for an additional cost - please see the report following purchase for more information. The analyst reaches millions of people through its portfolio of 45+ condition-specific online health communities - including PlaquePsoriasis.com - to provide information, connection, and support to patients and caregivers in the U.S. This report includes a deep-dive into: Psoriasis patient demographics Age, gender, ethnicity, marital status, children, employment status, income, location, insurance, and other health conditions Impact of psoriasis on quality of life Severity, impact on quality of life, symptoms experienced, and what patients wish others better understood Information-seeking behaviors Information sources used, plus topics of interest HCP engagement Primary HCP seen for condition, satisfaction with HCP, and discussion about brands aware of/not used Psoriasis treatment awareness and experiences Aided awareness of specific treatments, treatment experience, satisfaction with current treatments, perceived control with current treatment plan, and interest/participation in clinical trials Key questions answered in this report: To what extent do people say psoriasis impacts their overall quality of life? What's the average number of flares in the past year? What do patients wish others understood about psoriasis? What percentage of patients see a specialist for psoriasis treatment? What treatments have the highest aided brand awareness among patients? What percentage of patients use a biologic? How many patients feel their psoriasis is well-controlled on their current treatment plan? What percentage of patients are likely to switch or add new treatments in the next six months? What medications have patients discussed with their HCP? What are the top online resources people with psoriasis use to find information? What kinds of content and information do patients search for? What percentage of patients search for information on treatment options? Methodology Psoriasis in America consists of: A 20-minute online quantitative survey, covering demographics, comorbidities, quality of life/impact, HCP interactions, as well as treatment awareness, experiences, and discussions Qualitative patient insights from open-ended responses Additional details: Fielded: January 16, 2023 to April 14, 2023 Convenience sample of 490 respondents diagnosed with psoriasis Respondents are age 18+, living in the U.S., and are recruited from proprietary online health communities and recruiting partners Key Topics Covered: Respondent Demographics Research Highlights Condition Status and Quality of Life Severity and Exacerbations Symptoms Experienced Impact on Quality of Life Qualitative Patient Insights Information-Seeking Behaviors Resources Used to Manage Health Types of Content/Information Sought Treatment Awareness and Experiences Primary HCP Seen for Psoriasis Care Aided Brand Awareness of Treatments Treatment Usage Condition Control on Current Treatment and Clinical Trial Interest Treatment Discussions with HCP Appendix with All Data Charts and Distributions Brands and treatments mentioned in this report include: Topical corticosteroid (such as hydrocortisone) BRYHALIT (halobetasol propionate) lotion DesOwen (desonide) SERNIVOT (betamethasone dipropionate) SORILUXT Foam (calcipotriene) TACLONEX (calcipotriene and betamethasone) TAZORAC (tazarotene) VECTICAL (calcitriol) VTAMA (tapinarof) ZITHRANOLT-RR (anthralin) ZORYVET (roflumilast) Acitretin (SORIATANE) ARAVA (leflunomide) Azathioprine (such as IMURAN, AZASAN) Cyclosporine (such as Sandimmune, NEORAL, RESTASIS) Methotrexate (eg, Rheumatrex), also sometimes given as an injection OTEZLA (apremilast) PLAQUENIL (hydroxychloroquine) RINVOQ (upadacitinib) SOTYKTUT (deucravacitinib) Sulfasalazine (Azulfidine) XELJANZ/XELJANZ XR (tofacitinib citrate) AMJEVITAT (adalimumab-atto) Hide until launched in US AVSOLA (infliximab-axxq) CIMZIA (certolizumab) COSENTYX (secukinumab) CYLTEZO (adalimumab-adbm) Hide until launched in US ENBREL (etanercept) ERELZIT (etanercept-szzs) Hide until launched in US HULIO (adalimumab-fkjp) Hide until launched in US HUMIRA (adalimumab) HYRIMOZ (adalimumab-adaz) Hide until launched in US ILUMYAT (tildrakizumab-asmn) INFLECTRA (infliximab-dyyb) IXIFIT (infliximab-qbtx) Hide until launched in US ORENCIA (abatacept) REMICADE (infliximab) RENFLEXIST (infliximab-abda) SIMPONI (golimumab) SIMPONI ARIA (golimumab for infusion) SILIQT (brodalumab) SKYRIZI (risankizumab-rzaa) STELARA (ustekinumab) TALTZ (ixekizumab) TREMFYA (guselkumab) For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

2023-11-21

·BioSpace

Sandoz launches Hyrimoz® (adalimumab) high-concentration formulation in Europe, aiming to improve patient care

Biosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) indicated for all conditions of reference medicine Humira®* Hyrimoz® HCF to launch progressively across Europe Hyrimoz® HCF strengthens well-established Sandoz biosimilar immunology portfolio in Europe Basel, November 21, 2023 – Sandoz, the global leader in generic and biosimilar medicines, today announces the launch of Hyrimoz® (adalimumab) citrate-free high concentration formulation (HCF; 100 mg/mL) in Europe. The medicine will become available to patients progressively across European markets, starting today. Hyrimoz® HCF, like the currently available 50mg/mL version of Hyrimoz®, is indicated for all conditions covered by the reference medicine*: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.1 Rebecca Guntern, President Europe Sandoz said: “People living with chronic inflammatory conditions can experience debilitating effects on daily life. The launch of Hyrimoz® HCF in Europe is a key milestone in offering an additional treatment option to those that need it and showcases our unwavering commitment to expanding access to high-quality medicines.” Hyrimoz® citrate-free HCF is an updated formulation (100 mg/mL) to the currently available Hyrimoz® 50 mg/mL and offers a 50 percent reduction in injection volume, thereby potentially decreasing the number of injections required for patients who need 80 mg/mL or higher dosing. The HCF formulation is administered with the familiar Hyrimoz® SensoReady® pen, aiming for an enhanced yet familiar patient experience. The launch of Hyrimoz ® HCF strengthens the Sandoz biosimilar portfolio in immunology, including Erelzi® (biosimilar etanercept), Zessly® (biosimilar infliximab) and Rixathon® (biosimilar rituximab, including rheumatoid arthritis indication). Hyrimoz® citrate-free HCF (adalimumab-adaz) launched in the US in July 2023. Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably across a range of areas including immunology, oncology, supportive care, and endocrinology. It has a leading global portfolio with eight marketed biosimilars and a further 25 assets in various stages of development. Since launching the first biosimilar in Europe in 2006, Sandoz has helped to create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels further innovation. About adalimumab Adalimumab is a human immunoglobulin G1 (IgG(1)) monoclonal antibody targeting tumor necrosis factor alpha (TNF-a). The adalimumab reference medicine (Humira®*) was first approved with an adalimumab concentration of 50 mg/mL.1 In 2015, the EMA and US FDA approved Humira® HCF, which contains adalimumab at a concentration of 100 mg/mL. Disclaimer This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. References EMA. Humira® EPAR Product Information. Available from: . [Accessed October 2023] *Humira® is a registered trademark of AbbVie Biotechnology Ltd # # # About Sandoz Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. 22,000 people of more than 100 nationalities work together to bring Sandoz medicines to some 500 million patients worldwide, generating substantial global healthcare savings and an even larger total social impact. Its leading portfolio of more than 1500 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to the year 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2022, Sandoz achieved sales of USD 9.1 billion and core EBITDA of USD 1.9 billion. Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer +49 171 838 4838 Karen M. King +1 609 722 0982 Chris Lewis +49 174 244 9501 Laurent de Weck +41 79 795 7364 Attachment Media Release Hyrimoz Launch Version FINAL

上市批准生物类似药专利到期免疫疗法

2023-06-19

·生物制药小编

失落的价格屠夫，生物类似药逆袭失败真相

本文作者为「氨基观察」特约研究员杨翼每一家生物类似药的制造商们，最乐于等待的必然是重磅炸弹日薄西山的到来。在他们看来，“敢教日月换新天“就是一夜之间的事情。可以理解。全球第一个生物类似药于2006年在欧洲上市，此后逐渐抢班夺权，瓜分品牌生物制剂打下的江山。美国生物类似药市场起步较晚，第一个game changer直到2015年底才姗姗来迟。但大幕迅速拉开，截至2022年12月底，FDA已批准40 款生物类似药。2023年，更是生物类似药大事记年份。在这一年，药王阿达木单抗在美国的专利正式到期，将有多达10种生物类似药一拥而上。之后，或许会诞生诸多生物类似药的传奇。但是，问题也由此而来：成为game changer，真的这么容易吗？答案是否定的。从过去十几年的历程来看，生物类似药不如意者，虽然称不上十之八九，但市场占有率不佳的后来者绝不罕见。也就是说，并非每一款生物类似药，都能颠覆前辈们的game changer。/ 01 /从低迷的英夫利昔单抗类似药说起英夫利昔单抗的挑战者们，便吃了瘪。英夫利昔单抗由强生研发，是一种用于治疗多种自身免疫性疾病的嵌合单克隆抗体，适应证包括克罗恩病、溃疡性结肠炎、类风湿性关节炎、强直性脊柱炎、银屑病、银屑病关节炎和白塞病。由于囊括众多适应症，英夫利昔单抗销售额峰值超过80亿美金。在这一背景下，随着其专利的到期，类似药挑战者大举入侵。首个英夫利昔单抗生物类似药infliximab-dybb，于 2016 年进入美国市场。随后，又有多款类似药相继上市：• infliximab-qbtx: Ixifi®，辉瑞，2017年12月获批• infliximab-axxq: Avsola®, Amgen, 2019年12月获批• infliximab-abda: Renflexis®, Samsung Bioepis Co., 2017年4月获批然而，这些挑战者们入侵失败了。虽然已进入市场多年，但英夫利昔单抗类似药的日子并不如意。有研究人员调查了英夫利昔单抗生物类似药在美国的使用情况。研究发现，2016年至2022年间，32916人使用了生物原研药英夫利昔单抗。与之相对的是，只有不到7000人使用了英夫利昔单抗生物类似药。也就是说，面对生物类似药的市场侵蚀，生物原研药仍然掌握84%的患者群体，而三款生物类似药只能在剩下的16%的市场里面“取一瓢饮”。截至2022年12月，英夫利昔单抗原研药仍然牢牢占据超过70%的市场。这也得到了医院的证实。在102家具有一定规模的风湿病学机构中（英夫利昔单抗使用者超过20人），16.6%的机构中根本就没有患者使用生物类似药，处于“查无此药”的状态；有27.4%的机构，其生物类似药的患者使用率在1%到10%之间。只有15.6%的机构，它们拥有超过一半的患者在使用这些生物类似药。从统计学角度看，年龄、性别、种族、民族、保险、地区和风湿病诊断的标准偏差均不大于0.5，说明不同组别的患者特征差异非常微小。这意味着，没有一个突出的因素导致了患者选择不同类比的药物。在美国，类似英夫利昔单抗生物类似药水土不服的情况，比比皆是。一项针对“2019 年至 2021 年间拥有雇主赞助保险的人群生物类似药使用现状”的分析显示，7款总支出接近310亿美元的药物，其中5种生物类似药使用率低于三分之一。要知道，7种药物的原研药价格均显著高于生物类似药。价格差异最大的是filgrastim 和trastuzumab，比相对应的生物类似药贵50%以上。Bevacizumab生物制剂比生物类似药高 36%，其他四种品牌生物制剂的价格比仿制药高20%以上。这是一种包藏悖论的现象，价格更高的生物原研药（除epoetin之外）比价廉但效果可比的生物类似药更受欢迎。这又是为什么呢？/ 02 /难以跨越的中间商最大的因素之一，是难以跨越的中间商。与我国药品采购实行“两票制”不同。美国药物流通过程纷繁复杂，涉及到多个机构。其中，药房福利管理者是最关键的角色。药房福利管理者虽然不在流通环节中，但它却拥有审核医生处方、处方集的制定、药物价格的谈判等多项权力。根据EVERSANA数据显示，2017年，前三大药房福利管理者就已经影响全美73%的处方药销售。难以绕开的药房福利管理者，让原研药企有了狙击生物类似药的机会。通常来说，原研药制造商会在生物类似药上市前夕，与付款者签订多年回扣协议。回扣比例一般惊人。例如风湿病学使用的药物，如anti-TNF（抗肿瘤坏死因子），计划的回扣可接近药物标价的50%。除此之外，原研药生物制造商还为仿制药设置了所谓的“回扣陷阱”，即“有它无我“的威胁。很显然，如果将生物类似药列于处方集头牌位置，原研生物制品制造商就会向付款者发出威胁，撤回对于后者来说非常可观的回扣。对于PBM来说，显然不愿意见到这一局面。这就解释了，为什么只有很少量的商业医疗保险 D 部分计划涵盖生物类似药，而绝大多数的保险仍然主推生物原研药。英夫利昔单抗生物类似药难以打开市场，一个重要负面因素就是品牌生物制剂制造商与药房福利管理者之间的回扣安排。强生向 PBM 提供大量回扣，有效地降低了付款人的品牌产品费用。这使得生物类似药很难在价格上竞争，因为回扣安排通常有利于参考产品。除了英夫利昔单抗生物类似药之外，掣肘于类似因素的生物类似药，还包括Pegfilgrastim，Bevacizumab，Trastuzumab和胰岛素等生物类似药。可以说，回扣和折扣的制约是生物类似药绕不开的障碍。/ 03 /医生的处方惯性除了回扣制度外，医生的处方惯性同样不容忽视。一项研究显示，超过三分之一的医生从未开过生物类似药的处方。这背后，影响的因素较多，大致可以分为以下几类：1）不熟悉：惯性是物体自带属性，人也一样，对于新鲜事物的接受总需要一个时间和过程，或长或短。医师可能更熟悉并更愿意开出上市时间较长的品牌参考产品。而生物类似药是相对较新的产品，医生对其使用的经验和熟悉度可能较低。这种不熟悉会导致在开具生物类似药处方时犹豫不决。2）功效和安全性担忧：虽然生物类似药经过严格测试并证明与参考产品相似，但与参考产品相比，一些医生可能仍对其功效和安全性担忧。这导致，医生可能会导致在开处方时犹豫不决，即使监管机构已确定它们高度相似。这就好比足球比赛中那句众人皆知的箴言：永远不要改变赢球的阵容。3）患者接受程度和类似药推广介绍：医生在做出处方决定时，也可能考虑患者对生物类似药的接受和理解。如果患者不熟悉生物类似药或对从参考产品转换有保留意见，医生可能会选择“就坡下驴”，视类似药而不见。4）风险规避：在医药领域这个可能荆棘遍布、步步惊心的领域，医生可能有一种自然而来的规避风险倾向，更愿意坚持熟悉的治疗方法。不良事件的潜在后果，就像悬在他们头顶上的达摩克利斯之剑一样，无形地推动者医师对新生事物采取敬而远之的态度，尤其是在真实世界数据尚不重组的情况下，以不变应万变也算是一种“明哲保身”的策略。5）报销和激励：与处方参考产品相关的报销结构和经济激励，会影响医生的行为。虽然药房福利管理和保险机构是获利的大户，但医师也是这个环节中重要的参与者。参考产品的折扣和更高的报销，以及复杂的回扣系统，可能会阻碍医生开出生物类似药的处方，尽管它们的标价较低。而报销政策可能会不利于价格较低的生物类似药。付款人通常对品牌参考产品和生物类似药采用不同的成本分摊结构。与品牌参考产品相比，生物类似药可能需要患者支付更高的自付费用，即使生物类似药的标价较低。/ 04 /监管问题和互换性生物类似药的监管非常复杂，也影响了类似药的商业前景。与小分子药物不同，生物药物不具有100% 相同的结构。例如蛋白质糖基化是可变性的一个重要来源，可以影响免疫原性、稳定性和临床疗效。根据现行的 FDA 法规，制造商需要提供数据证明从原研生物制剂和生物类似药的“生物相似性“，即安全性和有效性没有显著影响。如果一种生物原研药有多种适应症，那么生物类似药应用于原研药已经批准的其他适应症（而生物类似药自身没有临床数据），即所谓的”外推“（extrapolation），需要具有信服力的科学证明。除了外推正当性外，每个适应症的不同独占期可能会造成额外的批准延迟。除了一般性的监管批准挑战之外，生物类似药还要面临一个“可互换性“（interchangeability）的问题。所谓可互换，指的是一种生物类似药有望产生与原研药相同的临床结果。要获得此认定，生物类似药制造商需要向 FDA 提供额外信息，以评估产品之间交替或转换的风险。你可以理解为，国内的一致性评价。拥有“interchangeability“头衔的生物类似药，能够被医疗保健提供者替代参比产品，而无需处方医师的干预或批准。虽然，可互换性并不是生物类似药进入市场或开处方的必要条件，但会显著影响医疗保健提供者、患者和付款人的接受度。然而，要想获得该头衔，类似药制造商需要投入更多的成本，进行更多的临床以获得充足的数据。但面对巨大的不确定性，只有少部分药企愿意进行“生物相似性”的更多实验。这也导致，只有相当小一部分得到了FDA的“可互换”指定。也正因此，大部分没有获得认定的生物类似药，迟迟未能获得市场认可。/ 05 /总结生物类似药的推出，必然具有时代意义。在一家产品独大多年之后，它的价格也会像修美乐那样有恃无恐地“天天向上”，而生物类似药则是打破这一垄断的决定性因素。只是，如何去打破垄断，需要挑战者们耗费更多心思和精力去思考。正如本文所讨论的，并非每款生物类似药的上市，都能撼动原研药一家独大的局面。生物类似药要想脱颖而出，不能只靠价格取胜。这其中，还包括生物类似药本身的成本问题，也有监管因素、原研药制造商人为设置的障碍、保险过程中的利益瓜分者以及过程的不透明性，甚至包括患者和医师对于仿制药的不正确认识等。要想成为game changer，需要挑战者秀出更多肌肉。

专利到期生物类似药

100 项与英夫利西单抗生物类似药 (Pfizer) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB02	DB00065

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
葡萄膜炎	日本	Pfizer Inc.	2020-04-22
小儿溃疡性结肠炎	美国	Pfizer Manufacturing Ireland Unlimited Co.	2020-01-16
红皮病性银屑病	日本	Pfizer Inc.	2018-07-02
脓疱型银屑病	日本	Pfizer Inc.	2018-07-02
银屑病	欧盟	Sandoz GmbH	2018-05-18
银屑病	冰岛	Sandoz GmbH	2018-05-18
银屑病	列支敦士登	Sandoz GmbH	2018-05-18
银屑病	挪威	Sandoz GmbH	2018-05-18
强直性脊柱炎	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
银屑病关节炎	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
溃疡性结肠炎	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
克罗恩病	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
小儿克罗恩病	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
斑块状银屑病	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13
类风湿关节炎	美国	Pfizer Manufacturing Ireland Unlimited Co.	2017-12-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02222493 (REFLECTIONS B537-02, Pubmed \| BioDrugs) 人工标引	临床3期	类风湿关节炎	650	infliximab+methotrexate+PF-06438179	鬱製顧蓋願積齋範膚製(獵遞廠蓋淵鑰淵鏇膚醖) = 醖網簾夢遞憲構窪製築網蓋遞夢繭艱願簾鑰製 (築淵糧醖壓鬱鑰醖遞鏇 ) 更多	相似	2020-04-01
ACR2017	N/A	类风湿关节炎	-	SB2	餘顧築選簾夢鬱網廠鏇(鹹醖鑰壓築鬱願廠鹽衊) = 鬱艱壓齋襯繭繭網鑰衊夢鏇網範鹹壓鑰窪鑰構 (憲憲鹽鹽齋鬱襯簾顧糧 )	-	2017-11-07
				Reference Infliximab	餘顧築選簾夢鬱網廠鏇(鹹醖鑰壓築鬱願廠鹽衊) = 艱構鏇獵選艱糧夢簾蓋夢鏇網範鹹壓鑰窪鑰構 (憲憲鹽鹽齋鬱襯簾顧糧 )
NCT02222493 (REFLECTIONS B537-02, CTgov)	临床3期	类风湿关节炎	650	PF-06438179 (Period 1: PF-06438179)	鏇艱廠糧繭構糧淵襯繭(蓋繭襯窪觸襯膚窪醖選) = 鹹觸獵製鹹艱膚淵構襯糧夢壓繭觸願糧膚壓選 (廠蓋餘艱艱鹽獵膚鹹壓, 淵網齋構蓋憲糧築衊壓 ~ 鑰鹽淵顧願鑰範淵獵繭) 更多	-	2017-09-11
				Remicade (INX)+Infliximab (Period 1: Infliximab-EU Remicade (INX))	鏇艱廠糧繭構糧淵襯繭(蓋繭襯窪觸襯膚窪醖選) = 鏇廠夢襯鹹壓鹹範壓觸糧夢壓繭觸願糧膚壓選 (廠蓋餘艱艱鹽獵膚鹹壓, 獵製鹹願獵獵鬱繭獵範 ~ 餘鏇廠醖願窪艱構蓋構) 更多
EULAR2017	临床3期	类风湿关节炎	-	SB2	餘膚選糧築蓋簾襯蓋積(獵範夢壓選餘簾願遞廠) = 網窪夢製鹽壓繭製範構鹹選淵艱夢淵鹹構製廠 (夢製願製繭願廠糧蓋獵 )	-	2017-06-14
				Reference infliximab (INF)	餘膚選糧築蓋簾襯蓋積(獵範夢壓選餘簾願遞廠) = 窪艱廠願網廠艱願憲憲鹹選淵艱夢淵鹹構製廠 (夢製願製繭願廠糧蓋獵 )