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Role of Proteomics in Characterization of Biosimilar Products

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Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges

Abstract

Biomarker discovery has been one of the central foci of proteomic research globally. However, in developing countries, the road map to achieving this is not very straightforward. Biomarker post regulatory checks are often known to be sold at exorbitant prices in the markets. The ever-increasing cost of healthcare together with our improving understanding of biotech therapeutic drugs has fueled the rise of biosimilars. Biosimilars are defined as biotechnological products that have been proved to be comparable to an already approved reference product in quality, nonclinical, and clinical evaluation. Discussion and resolution of the various scientific and regulatory factors that play a role in approval of biosimilars are arguably one of the most significant events over the last decade for biotechnology. Key scientific factors include the complexity of biotech products and processes, use of complex raw materials that are not always well characterized, and our relatively limited understanding of how the numerous quality attributes that define a biotherapeutic impact the product’s safety and/or efficacy in the clinic. A key step toward achieving successful development of a biosimilar is to establish analytical comparability with the innovator drug. This is necessary for the biosimilar manufacturer to avail of the significant reduction in clinical data required for achieving regulatory approval. Proteomic-based analytical tools have played an important role and have gradually emerged as a major resource for characterization of analytical information to characterize these biosimilars, thereby playing a major role in the biosimilar revolution. This chapter addresses major developments that have taken place in the use of proteomics toward development of biosimilars with a focus on progress made in the last 5 years.

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Authors and Affiliations

  1. Department of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, 110016, India

    Anurag S. Rathore, Sumit K. Singh, Neh Nupur & Gunjan Narula

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  1. Anurag S. Rathore
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  2. Sumit K. Singh
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  3. Neh Nupur
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  4. Gunjan Narula
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Correspondence to Anurag S. Rathore .

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  1. Department of Biosciences and Bioengineering, IIT Bombay, Mumbai, Maharashtra, India

    Sanjeeva Srivastava

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Rathore, A.S., Singh, S.K., Nupur, N., Narula, G. (2016). Role of Proteomics in Characterization of Biosimilar Products. In: Srivastava, S. (eds) Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges. Springer, New Delhi. https://doi.org/10.1007/978-81-322-2837-0_7

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