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Biorbyt科研专题/ 生物仿制药 Biosimilars

发布时间:2021-03-05 15:13 点击次数:

Biorbyt科研专题/ 生物仿制药 Biosimilars

原创 biorbyt 英国biorbyt 1
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#biorbyt 32
 
#研究领域产品 28
 生物仿制药背景 Biosimilars Background  生物仿制药定义为与预先批准的参考生物药物高度相似的生物药品(也称为生物制剂)。生物仿制药是根据药品质量,安全性和功效的相同标准批准的,该标准适用于药品监管机构(例如EMA(EU)和FDA(US))设定的所有生物药品。与通过化学合成方法生产的非专利药物不同,生物药物包含一种或多种源自生物来源的活性成分,例如重组蛋白。与更常见的基于小分子的药物相比,生物制剂通常表现出高分子复杂性,并且对制造过程中的变化较敏感。 A biosimilar is defined as a biopharmaceutical product (also known as a biologic), which is highly similar to a pre-approved reference biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines set by drug regulatory authorities, such as EMA (EU) and the FDA (US). Unlike generic medicines manufactured via chemical synthesis, biologic medicines contain one or more active components derived from a biologic source, such as recombinant proteins. In contrast to the more common small molecule-based drugs, biologics usually exhibit high molecular complexity and can be sensitive to changes during the manufacturing processes. 

● 欧盟是世界上第一个建立生物仿制药批准框架的地区。The EU was the first region in the world to establish a framework for the approval of biosimilar medicines.

 

● 自2006年以来,EMA已授予50多种生物仿制药的授权。The EMA has granted authorization for over 50 biosimilars since 2006.

 

● 欧盟批准了第一个基于英夫利昔单抗的单克隆抗体生物仿制药。The EU approved the first biosimilar of a monoclonal antibody based on infliximab.

 

● 2015年,FDA批准了美国第一个生物仿制药产品filgrastim-sndz。In 2015 the FDA approved the USA’s first biosimilar product, filgrastim-sndz.

 

 生物制剂与传统药物的比较Biologics versus Traditional Drugs   Fig. 1. Biologics versus Traditional Drugs

 

传统药物 生物制剂
● 通过化学合成生产Produced by chemical synthesis ● 低分子量 Low molecular weight ●稳定的理化特性Stable physicochemical properties ●经常有特殊毒性 Often specific toxicity ●通常是非抗原的 Often non-antigenic ●由宿主细胞系生物技术生产Biotechnologically produced by host cell lines ●高分子量 High molecular weight ●主要是受体介导的毒性Mostly receptor-mediated toxicity ● 通常是抗原性的Usually antigenic

 

 

生物制品和生物仿制药的生产

Manufacturing Biologics and Biosimilars 

 

自人类生长激素,胰岛素和红血球刺激剂开发以来,生物制剂已经生产了数十年。通过基因组学研究的指数增长以及对亚细胞级联和疾病病理学的更深入了解,潜在靶标库已迅速增加。用于开发生物制剂的科学领域包括基因组学和蛋白质组学,以及微阵列,细胞培养和单克隆抗体技术。

Biologics have been manufactured for decades since the development of human growth hormone, insulin, and red-blood cell stimulating agents. The library of potential targets has increased rapidly through the exponential growth in genomics research coupled with a greater understanding of subcellular cascades and disease pathology. Scientific fields used in developing biologics include genomics and proteomics, as well as microarray, cell culture, and monoclonal antibody technologies.

 

生物制剂的治疗靶标始终是基因或蛋白质。重组DNA是生物制剂生产中的重要组成部分,它需要从细胞中分离DNA并可能修饰该DNA片段,将其插入细菌或哺乳动物细胞宿主中并诱导表达。

The therapeutic target of a biologic is always a gene or a protein. Recombinant DNA, an important component in the production of biologics, requires the isolation of DNA from cells and potentially modifying that DNA segment, inserting it into a bacterial or a mammalian cell host, and inducing expression.

 

 

开发生物仿制药的步骤

Steps in developing Biosimilars 

Fig. 2. Steps in developing Biosimilars

 

开发过程中需要几个步骤:

所有新近鉴定的目标蛋白都经过一系列基于细胞的分析,从而提供了有关其参与各种生物过程的进一步信息。然后利用生物活体或组织中的常见生物学指标进行生物测定以确定效力。这些可以包括基于细胞的组织培养,微阵列表达技术,基因敲除/转基因动物模型以及反义或抗体技术,例如诊断性抗体表征。 

Several steps are required in the development process:

All newly identified proteins of interest undergo a series of cell-based assays providing further information on their involvement in various biological processes. Bioassays are then performed to determine potency, utilizing common biological indicators in living organisms or tissues. These can include cell-based tissue cultures, microarray expression technology, knockout / transgenic animal models and anti-sense or antibody technology, such as diagnostic antibody characterization.

 

 

 

生物仿制药的研究现状

Biosimilars in Research

 

生物制剂和生物仿制药的未来是明确的,其研发会持续,并且在临床和研究环境中的使用正在逐步增加。由于FDA和EMA对生物仿制药的审批程序减少,生物药物价格会有降低趋势。

The future of biologics and biosimilars is clear; they are here to stay and their use in both clinical and research settings is rising. Due to the reduced approval process required of the FDA and EMA for biosimilars, these drugs are typically less expensive, by approximately one-half in some cases.

 

从研究的角度来看,仅使用一部分生物制剂研发费用的生物仿制药就可以提供几乎相同的替代方案。所以使用生物仿制药可以大大降低试剂成本,并同时能获得一致的有效结果。但是,产生可靠的靶向生物仿制药的抗体需要许多更专业的经验和更多研发时间,这是许多研发人员所缺乏的。

From a research perspective, biosimilars offer a near identical alternative for the fraction of the cost of biologics. Using a biosimilar will reduce reagent costs without impacting the validity of your results. However, producing antibodies that reliably target biosimilars requires a wealth of experience and time that many researchers do not have.

 

 

Biorbyt能够提供针对最常用生物仿制药的广泛抗体,例如CD47抗体(马格利单抗生物仿制药)。请参阅以下精选的biorbyt火爆的生物仿制药相关靶向抗体产品,欢迎联系咨询。

 

Catalog No. Name                              Applications
orb689306 CD47 (magrolimab biosimilar) antibody ELISA, FC
orb689307 CS1 (elotuzumab biosimilar) antibody ELISA, FC
orb689308 CD123 (talacotuzumab biosimilar) antibody ELISA, FC
orb689309 CD38 (daratumumab biosimilar) antibody ELISA, FC
orb689310 CD70 (vorsetuzumab biosimilar) antibody ELISA, FC
orb689311 PD-1 (pembrolizumab biosimilar) antibody ELISA, FC
orb689312 IL6 (siltuximab biosimilar) antibody ELISA, FC
orb689313 TIM3 (cobolimab biosimilar) antibody ELISA, FC
orb689314 PDL1 (atezolizumab biosimilar) antibody ELISA, FC
orb689315 B7-H3 (enoblituzumab biosimilar) antibody ELISA, FC

 

 

参考资料:

1. European Medicines Agency (EMA)

2. Food and Drug Administration (FDA)

3. Advances in Drug Development- Current Developments in Oncology Drug Research: The Benefits and Drawbacks of Biosimilars- Bruce N. Cronstein, MD

4. Morrow T, Felcone LH. Defining the difference: What Makes Biologics Unique. Biotechnol Healthc. 2004;1(4):24-29.

5. Biosimilars: An overview (March 2011)

6. DOI: 10.2147/BS.S16120

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