A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre Filled Syringe (40 mg) Continuously and Subjects Undergoing Repeated Switches Between Humira® Pre Filled Syringe (40 mg) and Hulio Pre-filled Syringe (40 mg)

Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira.
This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product.
The study will also assess safety, efficacy and immunogenicity between these two groups.

开始日期2022-11-21

申办/合作机构

Biocon Biologics, Inc.

[+2]

JPRN-jRCT2071200057 / Completed临床1期IIT

A Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study

开始日期2017-07-08

申办/合作机构-

CTRI/2016/02/006625 / Completed临床3期

A randomized, double-blind, multicenter, phase 3 study to compare the efficacy and safety of BMO-2 (adalimumab) and HumiraÂ® (adalimumab) in patients with active rheumatoid arthritis - BMO-2

开始日期2016-08-09

申办/合作机构

Biocon Research Ltd.

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100 项与阿达木单抗生物类似药 (Biocon) 相关的专利（医药）

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项与阿达木单抗生物类似药 (Biocon) 相关的文献（医药）

2022-01-01·Journal of Colloid and Interface Science2区 · 化学

Facile construction of novel organic–inorganic tetra (4-carboxyphenyl) porphyrin/Bi2MoO6 heterojunction for tetracycline degradation: Performance, degradation pathways, intermediate toxicity analysis and mechanism insight

2区 · 化学

Article

作者: Liu, Yanping ; Cai, Mingjie ; Zhang, Huiqiu ; Li, Shijie ; Wang, Chunchun ; Liu, Jianshe ; Yang, Fang

Developing durable photocatalysts with highly efficient antibiotics degradation is crucial for environment purification. Herein, tetra (4-carboxyphenyl) porphyrin (TCPP) was loaded onto the surface of Bi₂MoO₆ microspheres to gain hierarchical organic-inorganic TCPP/Bi₂MoO₆ (TCPP/BMO) heterojunctions via a facile impregnation strategy. The catalytic properties of these catalysts were comprehensively investigated through the photodegradation of tetracycline hydrochloride (TC) under visible light. Among all the TCPP/BMO heterojunctions, the highest photodegradation rate constant (0.0278 min^-1) was achieved with 0.25 wt% TCPP (TCPP/BMO-2), which was approximately 1.15 folds greater than that of pristine Bi₂MoO₆ and far superior to pure TCPP. The extremely high photocatalytic performance is attributed to the interfacial interaction between TCPP and Bi₂MoO₆, which favors the efficient separation of charge carriers and the enhancement of visible-light absorbance. TCPP/BMO-2 possesses high mineralization capability and good recycling performance. Photo-induced O₂^-, h⁺, and OH were mainly responsible for the degradation of TC. The degradation pathways of TC and toxicity of degradation intermediates were analyzed based on the intermediates detected by the high performance liquid chromatography-mass spectrometer (HPLC-MS) and the toxicity assessment by the quantitative structure-activity relationship (QSAR) prediction. A possible photocatalytic mechanism over TCPP/BMO is proposed. This work offers an insight in developing the porphyrin-based organic-inorganic heterojunctions for effectively remedying pharmaceutical wastewater.

2015-11-01·Sheng wu gong cheng xue bao = Chinese journal of biotechnology

[Cloning and expression profile of Bmyan in the silkworm (Bombyx mori) and experimental validation as one target of microRNA 7].

Article

作者: Zhou, Lanting ; Liu, Shiping ; Xia, Qingyou ; Wu, Xiaoyan ; Yin, Jiyun ; Huang, Yaxi ; Wang, Wei

microRNAs (miRNAs) are an extensive class of -22-nucleotide (nt) endogenous noncoding RNAs regulating life activities ofmetazoans through binding to 3'-untranslated regions (3'-UTRs) of their target genes. This work aimed to identify yan gene in the silkworm, reveal its expression profile and confirm if it is one target of bmo-miR-7 and, as such, have potential for contributing to better understanding of the molecular mechanisms involved in the metamorphosis of silkworm. Based on homolog searching and PCR amplification, we cloned the coding sequence (CDS) of Bmyan, which encodes 476 amino acid residues and contains SAM-PNT and ETs domains. Quantitative PCR (q-PCR), RT-PCR and microarray data revealed high expression of Bmyan in the head, body wall and ovary of day-3 fifth instar larval silkworm, low or no expression in other tissues. It was lowly expressed in the early larval stages, but highly expressed from late spinning to day 4 pupa. The 3'-UTR of Bmyan was obtained by rapid-amplification of cDNA ends (3'RACE) and predicted to contain two potential recognition sites of bmo-miR-7. The luciferase reporter vector containing the 3'-UTR of Bmyan was constructed and co-transfected into BmE cell line with the mimic of bmo-miR-7 and the decreased relative activity of luciferase showed that Bmyan is one target of bmo-miR-7. This work helps further functional analysis of bmo-miR-7 and Bmyan in the silkworm.

2013-03-01·Russian Journal of Bioorganic Chemistry

Bmo-miR-9a down regulates the expression of Bm-ase Gene in vitro

Article

作者: Xingjia Shen ; Fei Song ; Xin Wang ; Shunming Tang ; Yong C Huang

MicroRNAs (miRNAs) are a class of non-protein coding small RNAs of 18-24 nucleotides in length that regulate expression of genes at post-transcriptional levels and play multiple roles in biological processes. Bm-ase plays an important role in the course of nerve development of the silkworm, Bombyx mori. Bmo-miR-9a is a conservative miRNA. By using target prediction software RNA22 and RNAhybrid, we found a target site of Bmo-miR-9a in the 3'UTR of Bm-ase gene. To verify the regulation function of Bmo-miR-9a on the expression of Bm-ase gene, a Bmo-miR-9a over-expressing vector and Bm-ase 3'UTR fused firefly luciferase gene reporter plasmid were constructed, respectively. Then they were used to co-transfect the BmN cells. The result showed that luciferase activity in the co-transfected cells was suppressed compared with the control. A similar result was obtained when BmN cells were co-transfected with artificial synthetic Bmo-miR-9a mimics and Bm-ase 3'UTR fused luciferase reporter plasmid. These results suggest that Bmo-miR-9a can down regulate the expression of Bm-ase gene.

项与阿达木单抗生物类似药 (Biocon) 相关的新闻（医药）

2024-09-25

·PRNewswire

Biocon Biologics Announces New Dermatology Data to Be Presented at EADV Congress 2024

Switching between adalimumab and adalimumab-fkjp in Phase 3 study in patients with chronic plaque psoriasis supports interchangeability between adalimumab and adalimumab-fkjp Biosimilarity between Bmab 1200 and reference biologic-Ustekinumab in pivotal Phase 3 trial in patients with moderate to severe chronic plaque psoriasis AMSTERDAM and BENGALURU, India, Sept. 25, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "The extensive range of new data being presented at EADV this year underscores Biocon Biologics' commitment to a high-science portfolio of biosimilar medicines that meet the clinical needs of physicians and patients while providing important sustainability benefits to health systems. These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity without variation of clinical outputs in patients with chronic plaque psoriasis." Poster Title: Multiple switching between the biosimilar adalimumab-fkjp low concentration and reference adalimumab high concentration in patients with chronic plaque psoriasis: a phase 3, double-blind, randomised, parallel-group study Authors: Sarika Deodhar, Subramanian Loganathan, Ramesh Ks, Gopi Ranganna, Shiyao Liu, Matthew A. Hummel Hummel, Stefan Daniluk, Anna Hanczewska, Kamelia Vekovska, Maria Zegadlo-Mylik, Grazyna Pulka, Elena Wolff-Holz Abstract ID: 3809 Poster ID: P3241 Date/Time: 9:00am EDT, September 25, 2024 This study evaluated the pharmacokinetics (PK), efficacy, safety, and immunogenicity in patients with moderate to severe chronic Plaque Psoriasis (PPs) receiving adalimumab continuously and those undergoing repeated switches between reference adalimumab and adalimumab-fkjp. The primary objective was to evaluate interchangeability of low-concentration adalimumab-fkjp (40 mg/0.8ml) and high-concentration adalimumab (40 mg/0.4ml) by comparing adalimumab steady-state PK between switching and non-switching arms. The overall number and proportion of patients with Psoriasis Area and Severity Index (PASI) responses and static Physicians Global Assessment (sPGA) success were highly similar between the two arms at week 28. Treatment-emergent Adverse Events were comparable between switching [54 subjects (29.8%)] and non-switching arms [66 subjects (34.2%)]. The overall number and proportion of patients with PASI responses and sPGA success were highly similar between the two arms at week 28. This study confirmed that the subjects receiving adalimumab-fkjp low concentration and adalimumab high concentration in alternate fashion had highly similar time concentration curves compared to continuous administration of high-concentration reference adalimumab, and demonstrated PK equivalence between switching and non-switching arms. The overall data supports interchangeability between high-concentration adalimumab and low-concentration adalimumab-fkjp. This study was conducted to fulfill the U.S. Food and Drug Administration (FDA) requirement for designation as an "interchangeable" and has been submitted to the FDA. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "For physicians, an important unmet need is understanding the comparative safety, efficacy and exposure of an adalimumab biosimilar formulated at a low concentration and high-concentration adalimumab at dose parity. The data from the study shows clearly that in patients the same safety, efficacy and exposure when used at dose parity can be expected for both products. This in the context of multiple switches between the reference product and the biosimilar as required of an interchangeability study." Poster Title: A Randomized, Double-blind, Parallel Group, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Bmab 1200 and Reference Biologic-Ustekinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis 28-week Results Authors: Jacek Szepietowski, Adam Reich, Steven Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Junior Tsiskarishvili, Inese Kolontaja-Zaube, Airi Poder, Gursharan Singh, Subramanian Loganathan, Elena Wolff-Holz, Sarika Deodhar, Ashwani Marwah, Sandeep Athalye Abstract ID: 4382 Poster ID: P3266 Date/Time: 9:00am EDT, September 25, 2024 This pivotal Phase 3, randomized, double-blind, active controlled, parallel-group, multicenter study compared the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of Bmab 1200 with the reference product ustekinumab in adult patients with moderate to severe chronic plaque psoriasis (Pso). A total of 384 patients were evaluated for 52 weeks and the primary efficacy endpoint was percentage change from baseline (%CFB) in PASI at Week 12. In the primary efficacy analysis at 28 weeks, Bmab 1200 and ustekinumab were equivalent and the data support biosimilarity. The study established equivalent efficacy and comparable safety of Bmab 1200 with ustekinumab in patients with moderate to severe chronic plaque Pso. Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, "This pivotal trial of bUstekinumab clearly met the safety and efficacy endpoints, thereby fulfilling the expectations set for a biosimilar. bUstekinumab offers tangible promise for all patients qualifying for treatment with Ustekinumab." About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives. It is capitalizing on its 'lab to market' capabilities to serve millions of patients across 120+ countries by enabling affordable access to high quality biosimilars. The Company is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases. The Company has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, it is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website ; Follow us on X (formerly Twitter): @BioconBiologics and LinkedIn: Biocon Biologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow-us on X (formerly Twitter) @bioconlimited and LinkedIn: Biocon for company updates. SOURCE Biocon Biologics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果免疫疗法

2024-07-19

·Pharmaceutical Technology

Boehringer Ingelheim offers Humira biosimilar at 92% discount

Boehringer Ingelheim is a key player in the Humira biosimilars market. Image credit: Shutterstock / Tada Images. Boehringer Ingelheim will sell an unbranded version AbbVie’s reference drug at a 92% discount to gain traction in the Humira (adalimumab) biosimilar market. Patients will be able to purchase adalimumab-adbm exclusively through GoodRx, an online telemedicine company that works with pharma manufacturers to offer prescription drugs at reduced prices. Effective immediately, the price for a two-pack pre-filled syringe or autoinjector has been set at $550, representing a 92% discount on Humira’s list price, Boehringer Ingelheim and GoodRx said in a joint 18 July press release. AbbVie’s Humira lost patent protection last year, paving the way for a market proliferation of biosimilars. Biosimilars are drugs that are similar to US Food and Drug Administration-approved biologics. AbbVie’s anti-inflammatory blockbuster generated sales of $21.2bn in its last year of market exclusivity. Sales are expected to weaken, with an analysis by GlobalData predicting a revenue slump to $2.6bn by 2030. Humira previously cost $7,000 for a four-week supply at the list price. See Also: Exscientia acquires oral CDK7 inhibitor for $20m, plans breast cancer trial Gene therapy: How the CRO of Veristat cut trial database costs by 30% Humira’s weakening performance was captured when healthcare giant CVS Health dropped the medication from its list of covered drugs. CVS instead opted to launch a new subsidiary called Cordavis tasked with creating biosimilars. The company previously reported that the biosimilar market in the US is expected to top $100bn in revenues by 2029. Since Humira’s patents expired, 11 competitors have come to market with copycat drugs. Boehringer Ingelheim joined the arena last July with a branded version named Cyltezo – priced 5% lower than Humira. The company’s unbranded version, launched later, provided an 81% markdown on Humira. This price split strategy—launching branded and unbranded versions—was shared by Amgen and Biocon with their own Humira biosimilars Amjevita and Hulio. However, Boehringer Ingelheim had an underwhelming rollout with Cyltezo, with uptake slower than expected. The company even had to lay off employees earlier this year as a result. The GoodRx team-up is the latest effort by Boehringer Ingelheim to gain a share in the Humira biosimilar market. Boehringer Ingelheim’s value and access senior vice president Chris Marsh said: “Patients with certain chronic inflammatory diseases who do not have insurance or are underinsured may not be able to afford essential biologic medicines, including biosimilars, to treat their disease.” “Partnering with GoodRx to offer our biosimilar adalimumab-adbm at a low price to these patients helps us deliver on our commitment to lowering financial barriers and improving access to critical treatments.” AbbVie meanwhile has pinned hopes on its autoimmune drugs Skyrizi (risankizumab) and Rinvoq (upadacitinib) to counteract revenue losses from Humira. GlobalData analysts say that AbbVie’s two-pronged approach with these next-generation drugs means it has rebuffed much of its potential autoimmune sector marginalisation. For competitors on the other hand, it was a “missed opportunity”.

生物类似药上市批准基因疗法

2024-06-03

·药研网

为何十款类似药上市，修美乐仍能“独乐乐”

老药王修美乐已经从制药领域的宝座上退位，然而它在面对生物类似药的冲击时却表现得坚如磐石，其市场地位依然岿然不动。虽然销售量因为更高的回扣而大幅缩水，但处方量份额仍然高居不下。这种现象引发了行业内对于生物类似药法规策略的广泛讨论。首款修美乐生物类似药，Amgen的Amjevita (adalimumab-atto) 上市已经过去了一年多的时间了（2023年1月31日上市），之后又有九款类似物出现在了美国市场，它们针对的都是包括类风湿性关节炎、克罗恩病等自免疫疾病。5月2日，FDA最新批准了勃林格殷格翰公司的 Cyltezo的高浓度、无柠檬酸盐版本，它是修美乐的可互换生物类似药。本来，行业对于修美乐生物类似药上市之后市场占有率变化是相当期待的。但一年过去，这些生物类似药的市场占有率令人沮丧。通过生物类似药降低这些疾病治疗成本的愿景远未实现。从根源上来讲，政策制定者尚未采取必要行动来确保患者能够获得这些低成本产品。如果他们继续这种不作为的姿态，美国医疗保健系统可能会损失高达 1330 亿美元的成本，而且很多患者将无法获得所需的药物。Part.1无视类似药上市，修美乐价格不断攀升修美乐对于美国医疗保健体系的问题在于它的高价格和广泛患者群体，因此这款影响力巨大的药物才能收获历史超过2000亿美元的收入，但其对于医保体系的成本威胁也是不言而喻的。自从2003年上市以来，修美乐的价格每年都在攀升。2013年，每支40 mg 剂量的修美乐注射剂的价格已经从刚推出时的522美元上涨到了1024美元（图1）。就在首款生物类似药上市的2023年，艾伯维仍然选择对修美乐进行提价，达到了每针4000美元。从其生命周期管理来看，修美乐价格已经整体上涨了570.1%，达到如今每年84000-96000美元的水准。图1. 40 mg剂量修美乐注射器价格走势图。（图片来源：AbbVie）Part.2修美乐生物类似药2023年营销惨淡然而医疗保健系统对于打破修美乐“独乐乐”的愿景并没有随着生物类似药的登场而实现。根据生物类似药论坛（Biosimilar Forum）收集的修美乐生物类似药使用数据，2023 年，在 42000 名潜在的联邦政府保险计划Medicare的受益患者中，只有不到1000人接受了成本较低的 Humira生物类似药。生物类似药制造商 Samsung Bioepis 的另一份报告发现，尽管 9 种修美乐生物类似药的标价比修美乐低 85%，但它们在美国市场的占有份额甚至不到 2%（图2）。考虑到它们本可能带来的巨大成本节约，对这些药物的“束之高阁”使得医疗保险受益者和纳税人一年内损失30亿美元。在修美乐生物类似药中，Hadlima和Yusimry 提供的很低的WAC（Wholesale Acquisition Cost，批发收购成本），比 Humira 低约 85-86%；Idacio 和 Yuflyma 的WAC 较高，仅比 Humira 低约 5-6%；Cyltezo、Amjevita、Hyrimoz、Abrilada 和 Hulio 提供双重定价选项，包括低 WAC 和高 WAC（图3）。图2. 修美乐及其生物类似药2023年下半年市场占有份额走势图。（图片来源：Samsung Bioepis）图3. 修美乐生物类似药WAC价格图。（来源：Samsung Bioepis）根据美国联邦政府监察长办公室（Office of the Inspector General）的说法，如果患者可以使用修美乐和Enbrel（etanercept，另一种治疗自身免疫性疾病的药物）的生物类似药，并将其放在处方集的首选位置的话，那么联邦政府的Medicare计划每年可以节省数千万美元。但至少在2023年，这样的愿望没有得以实现。值得注意的是，修美乐生物药的市场占有率在PBM政策杠杆的影响下出现了抬头的趋势。BI的Cyltezo 的高浓度、无柠檬酸盐配方获得批准之际，生物类似药占据了更多的修美乐品牌药市场。本月早些时候，领先的药品福利管理公司 CVS Caremark 将修美乐从其主要的全国商业处方中剔除后，生物仿制药的处方量激增 36%。但需要注意的是，修美乐类似药抬头的背后是PBM开始垂直整合的策略。Sandoz 的生物仿制药 Hyrimoz (adalimumab-adaz) 由 CVS Health 子公司 Cordavis 共同开发和商业化，这一款类似药就占据了修美乐类似药增长的 93% 以上。其它类似药的占有率变化仍然有待观察。Part.3 美国与欧洲对修美乐生物类似药覆盖的巨大差异美国相对较低的市场吸纳率与整个欧洲的情况形成鲜明对比。欧洲的修美乐生物类似药已经上市五年多了（美国的专利丛林导致了修美乐生物类似药在美国延迟上市）。欧洲付款人的购买行为总是倾向于价格较低的治疗替代品，这从逻辑上来说是合理的。例如在部署卫生技术评估时，英国国家健康与护理卓越研究所（NICE）等机构建议医疗保健提供者，在同等有效的替代方案之间选择成本最低的治疗方法。欧洲和英国采购生物类似药的招标系统有助于提高生物类似药的吸收率。投标报价总是遵循正式程序，医院或医疗保健系统的招标过程，需要考虑替代方案在控制药品支出方面的贡献，因此物美价廉的生物类似药总能获得青睐。纵观整个欧洲，报销机构都强烈支持修美乐生物类似药，在许多司法管辖区获得了超过80% 的整体市场份额。而且很多监管机构都没有美国的“可互换性”指定，也促进了生物类似药处方量的增加。欧洲药品管理局许可的生物类似药数量是美国的两倍多（总共 93 种，截止2023年12月初），并且在大多数已批准生物类似药能够迅速占领市场。反观美国，生物类似药委员会（Biosimilars Council）进行的一项新分析发现，美国最大的五个提供Medicare Part D计划的保险公司（United Healthcare、Humana、CVS、Centene 和 Cigna）对于修美乐生物类似药的覆盖仅有6%，而对修美乐“本乐”的覆盖率达到99%（图4）。图4. 美国五大Medicare Part D健康保险机构对修美乐和修美乐生物类似药覆盖程度对比图。（来源：Biosimilars Council）Part.4修美乐“独乐乐”的根源从根源上讲，生物类似药无法与修美乐“同乐乐”的症结，并不在于这些类似药的安全性和有效性，也不在于它们是否带有“可互换性”（interchangeable）标签。问题出现在它们能否被PBM（药品福利管理者）纳入他们的“处方集”之中。这个处方集就是PBM之所以能够在60多年间，以一个不嫁不穑的角色在美国医疗系统中呼风唤雨、左拥右抱的关键。作为美国医疗健康系统中独特存在的“中间人”，PBM在上世纪60年代成立时的宗旨就是帮助单独的雇主保险机构进行行政方面的管理。PBM的产生源于对医疗保健系统中药品成本的管理和控制的需求。随着时间的推移，药品费用逐渐成为医疗支出中的重要部分。医疗保险公司、雇主和政府计划等支付者需要一种方式来管理和降低药品费用，以确保医疗保健系统的可负担性，并为受益人提供质量和经济效益。PBM 作为第三方管理者填补了这一需求的空白，通过谈判、合同管理、药品定价和利润管理等手段，协助支付者有效地管理药品成本，同时保障受益人的用药需求。因此，PBM 的产生是为了在医疗保健系统中更好地管理药品费用，实现成本控制和效率提升的目标。为什么PBM能够“一伸手就碰到天”？这主要在于他们在整个行业中的地位，尤其是他们制定的处方集（formulary）来决定的。处方集就像是PBM“挟天子以令诸侯”的法器一样。处方集是由 PBM制定的药品清单，用于指导医疗保险计划成员获得哪些药品的福利覆盖。这些药品被认作符合特定的临床标准、成本效益或其他标准，因此可以被医疗保险计划提供者批准并且支付。对于未被列入处方集的药品，医疗保险计划成员可能需要支付更高的费用或者根本不享受保险支付的福利。因此，PBM制定的处方集对于药品的市场准入、销售量、定价折扣和医生处方选择等方面具有重要影响。没有被纳入处方集的药品很难实现高市场吸收率，至少在美国如此。了解了PBM和处方集之后，我们再审视一下修美乐生物类似药被处方集吸纳的情况。从目前来看，Medicare 的D 部分对低成本修美乐生物类似药的吸纳率最低。在已推出的几种生物类似药中，有六种的定价结构具有低成本、低回扣的选择。折扣范围为 5% 至 86%，患者本应该获得这些低成本的选择。但实际情况却并非如此，如果医生开具了这些低价生物类似药，而它们并不被相应保险的处方集覆盖的话，让患者自掏腰包去购买这些相对便宜但仍然要每月500美元左右的生物类似药是非常困难的。因此在知道患者的倾向性的情况下，医生一般也不会开具不被纳入处方集的药物。就目前情况而言，PBM 继续青睐成本较高的品牌修美乐生物制剂，将其置于优先的处方集等级，患者更容易获得，而那些成本较低的生物类似药则设置了重重障碍。一些PBM甚至直接拒绝修美乐生物类似药进入处方集，并且没有解释原因（没有解释，就是解释了）。了解了处方集的重要性，下一步的问题就是，为什么PBM选择无视那些等效低价的修美乐生物类似药。道理也很容易理解，爱恨情仇都绕不开一个“钱”字。PBM 也是企业，它们也追求利润。纳入成本高的药物可以为 PBM 带来更高的回报，因为这些药物通常具有更高的利润率，表现在折扣和回扣的设定上。PBM 通常与药品制造商进行谈判，以获取更有利的定价和折扣条件。成本高的药物通常意味着更高的利润空间，制药公司可能会提供回扣或者折扣给PBM，“鼓励”他们将自己的高价药物纳入其处方集。这种回扣或折扣可能以多种形式出现，例如现金返还、折扣药价、赞助活动等。通过提供这些利益，制药公司可以确保他们的药物在PBM的处方集中占据有利位置，从而增加销售量和利润。PBM作为商业实体，其主要目标是盈利。在面临诸如回扣、折扣等利益的诱惑时，他们可能更倾向于选择高价药物，因为这些药物往往会带来更高的利润。虽然高价药物的成本更高，但如果PBM能够通过折扣或回扣等手段获取更多的利润，他们可能会更愿意选择这些药物。除此之外，一些制药公司可能与PBM签订药物回扣或利润共享协议。PBM可能会获得销售特定药物所带来的额外回报。因此，为了最大化其收益，PBM可能会优先选择这些药物，即使它们价格较高。至于谁最终承担了高价格的压力，是委托它们的国家保险机构或者雇主保险，还是更背后的广大患者和保户，PBM就不需要太多关心。他们当然不会把制药公司给他们的利益完全独吞，而是拿出一部分来“恩泽”他们的雇主，但究竟拿出了多少，就是外界很难获取的信息了。明白了这个道理，就不难理解为什么质量等同但价格更低的生物类似物入不了PBM“法眼”的原因了。生物类似药的低市场吸收率阻碍了自由市场竞争的发挥，但这并不是出于它们质量的问题，而且是立法机构如何支持这些低成本药物进入市场的调控政策出了问题。当处方药，特别是医疗保险处方药，优先考虑高成本、高回扣的产品时，最终遭受影响的是提供医疗保险的机构，包括Medicare和Mediaid这样联邦和州政府背景的保险机构，以及雇主保险，当然还有患者本人。今年第一季度出现的新情况，就是上文提及的PBM垂直整合，PBM从最初的裁判员变成了直接入场的运动员。在PBM的操作下，它们合作的生物类似药必然得到更快的市场占有率增长。尽管市场份额扩大，但PBM在整个流程中只手遮天的能力还是令人忧虑。Part.5“众乐乐”当从立法入手针对生物类似药市场吸收慢的问题，政策制定者明心见义地针对问题的根源，即PBM 的反竞争计划阻止患者获得低成本处方药。政策必须优先考虑患者，确保他们可以获得成本较低的生物类似药。迫使PBM吐出通过高价药物获得的高回扣和折扣利益，是政策制定者应当着重发力的方向。实际上，美国参议院财务委员会已经讨论并通过了立法草案，包含支持生物类似药的条款。该草案建议，从 2026 年开始，Mediacre D 部分计划必须涵盖“高折扣生物类似药”，而这些生物类似药的价格比其参考生物制剂至少低 45%，以此促进使用安全、有效和低成本的生物类似药，并直接降低患者的费用。生物类似药的积极“入市”，需要政策制定者“扶上马，送一程”。应尽快采取政策解决方案，让自由市场竞争成为主宰沉浮的主要力量。Ref.Humira cost savings and tips. Single Care. 05. 08. 2023.Brennan, Z. House committee uncovers how Humira’s price spiked by 470% as AbbVie execs cashed bonuses tied to the hikes. Endpoints News. Biosimilars Forum Supports Senate Finance Committee Legislative Discussion Draft Promoting Biosimilars. Biosimilar Development. 03. 11. 2023.Samsung Bioepis. Biosimilar Market Report. 4th Edition. Q1 2024.Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use. U.S. Department of Health and Human Services. Office of Inspector General. Mar. 2022.Cohen, J. Humira Biosimilars Not Gaining Traction Epitomizes Dysfunctional U.S. System. Forbes. 04. 12. 2023.Humira Biosimilar Landscape: Still Waiting. Biosimilars Council. 30. 01. 2024.Reed, J. M. A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira. STAT. 14. 02. 2024.End细胞系产品查询投稿丨商务合作转载丨加交流群往期回顾15月| 20家药企裁员（附名单）218亿美元，ADC又出海! 宜联生物宣布新授权32024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

生物类似药

100 项与阿达木单抗生物类似药 (Biocon) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
白塞氏葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
溃疡性结肠炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
全葡萄膜炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
类风湿关节炎	日本	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2020-06-29
幼年特发性关节炎	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
幼年特发性关节炎	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
小儿克罗恩病	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
斑块状银屑病	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17
葡萄膜炎	冰岛	Biosimilar Collaborations Ireland Ltd.	2018-09-17
葡萄膜炎	挪威	Biosimilar Collaborations Ireland Ltd.	2018-09-17
葡萄膜炎	欧盟	Biosimilar Collaborations Ireland Ltd.	2018-09-17
葡萄膜炎	列支敦士登	Biosimilar Collaborations Ireland Ltd.	2018-09-17

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
斑块状银屑病	临床3期	印度	Biocon Ltd.	-
类风湿关节炎	临床2期	德国	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	保加利亚	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	乌克兰	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	俄罗斯	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	秘鲁	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	智利	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	西班牙	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	波兰	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01
类风湿关节炎	临床2期	罗马尼亚	Fujifilm Kyowa Kirin Biologics Co., Ltd.	2014-12-01

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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


NCT05637515 (CTgov)	临床3期	斑块状银屑病	374	Humira (Group 1 :- Humira Continuously)	製醖窪廠觸鏇遞鹽顧膚(鬱廠鑰廠鑰憲製膚廠獵) = 鑰齋糧構糧憲顧鏇願鹹觸壓膚糧淵鬱築醖膚衊 (艱願選觸築壓遞築淵願, 壓積選範範憲願鬱觸艱 ~ 構壓淵襯夢醖繭鏇製鹹) 更多	-	2024-10-15
				Hulio+Humira (Group 2:- Repeated Switches Humira - Hulio)	製醖窪廠觸鏇遞鹽顧膚(鬱廠鑰廠鑰憲製膚廠獵) = 鹽醖鹽築壓艱鏇餘觸鹹觸壓膚糧淵鬱築醖膚衊 (艱願選觸築壓遞築淵願, 廠範憲繭積遞選襯鏇糧 ~ 網鏇淵鏇製襯顧壓餘廠) 更多
UEGW	N/A	炎症性肠病	-	Adalimumab originator	觸鹽醖醖醖獵艱製鏇壓(願鏇網醖窪鹽觸獵築蓋) = 33% stopped the biosimilar medication due to an allergic reaction 齋糧鑰範願襯簾繭鏇襯 (築網顧鹽鏇鬱選願鑰壓 ) 更多	-	2020-10-01
				Adalimumab biosimilar (Hulio)
NCT02260791 (Pubmed \| J Rheumatol) 人工标引	临床3期	类风湿关节炎	730	Methotrexate+Adalimumab-FKB-327	(鑰願積襯願觸築壓夢選) = 獵淵鑰鏇鬱積網簾窪膚壓糧醖夢築鑰簾蓋築鹹 (窪遞齋獵夢積構網廠醖 )	相似	2019-12-12
				Methotrexate+adalimumab	(鑰願積襯願觸築壓夢選) = 積顧網襯選積鑰醖鹽顧壓糧醖夢築鑰簾蓋築鹹 (窪遞齋獵夢積構網廠醖 )
EULAR2019	临床3期	类风湿关节炎	728	FKB327	(衊築積鏇襯憲壓淵製遞) = 遞遞糧積顧網範選築壓餘蓋鏇蓋蓋獵淵廠構鑰 (鹹膚繭獵鏇壓積網憲繭, 77.1 ~ 88.3) 更多	积极	2019-06-12
				Adalimumab RP	(衊築積鏇襯憲壓淵製遞) = 選製鬱鬱夢衊鬱醖醖壓餘蓋鏇蓋蓋獵淵廠構鑰 (鹹膚繭獵鏇壓積網憲繭, 74.8 ~ 90.4) 更多
NCT02260791 (ARABESC \| FKB327-002, CTgov)	临床3期	类风湿关节炎	728	FKB327 (FKB327)	醖蓋選顧積壓網鑰築顧(鑰廠衊鑰廠顧選糧廠蓋) = 構壓網顧淵顧網顧窪鹽鏇壓網艱餘簾鬱鏇製糧 (簾鏇獵築製願憲獵鏇積, 網觸壓壓觸醖願積網範 ~ 觸襯夢蓋遞餘簾鹽鬱餘) 更多	-	2017-09-20
				Humira® (Humira®)	醖蓋選顧積壓網鑰築顧(鑰廠衊鑰廠顧選糧廠蓋) = 遞衊願製齋繭遞衊衊獵鏇壓網艱餘簾鬱鏇製糧 (簾鏇獵築製願憲獵鏇積, 網窪齋網餘簾觸醖糧蓋 ~ 衊艱蓋窪鏇窪憲網鹽壓) 更多
NCT02260791 (FKB327-002, EULAR2017)	临床3期	类风湿关节炎 C-reactive protein \| antidrug antibodies	730	FKB327	(觸鏇糧鏇遞鬱淵願選淵) = 網繭窪遞範網選窪網憲衊淵襯遞獵廠窪簾膚蓋 (繭壓窪鹽鏇淵構網淵蓋 )	积极	2017-06-14
				ADL	(觸鏇糧鏇遞鬱淵願選淵) = 製顧衊夢艱淵蓋窪膚憲衊淵襯遞獵廠窪簾膚蓋 (繭壓窪鹽鏇淵構網淵蓋 )