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    Biosimilar Development

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    RAJAN GARG
    This document summarizes Hetero Biopharma's experience developing and commercializing biosimilars in India. It discusses their process which includes clone and cell line development, product development through clinical trials, and commercialization. Key products developed include darbepoetin alfa, rituximab, and bevacizumab. The development of these biosimilars followed Indian regulatory guidelines and included establishing biosimilarity to reference products through analytical, preclinical, and clinical studies. Biosimilars developed by Hetero Biopharma have been approved and commercialized in India to increase access and reduce healthcare costs.

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    Biosimilar Development

    Uploaded by

    RAJAN GARG
    121 views11 pages
    This document summarizes Hetero Biopharma's experience developing and commercializing biosimilars in India. It discusses their process which includes clone and cell line development, product development through clinical trials, and commercialization. Key products developed include darbepoetin alfa, rituximab, and bevacizumab. The development of these biosimilars followed Indian regulatory guidelines and included establishing biosimilarity to reference products through analytical, preclinical, and clinical studies. Biosimilars developed by Hetero Biopharma have been approved and commercialized in India to increase access and reduce healthcare costs.

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    Biosimilar

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    Biosimilar development

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    This document summarizes Hetero Biopharma's experience developing and commercializing biosimilars in India. It discusses their process which includes clone and cell line development, product development through clinical trials, and commercialization. Key products developed include darbepoetin alfa, rituximab, and bevacizumab. The development of these biosimilars followed Indian regulatory guidelines and included establishing biosimilarity to reference products through analytical, preclinical, and clinical studies. Biosimilars developed by Hetero Biopharma have been approved and commercialized in India to increase access and reduce healthcare costs.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    121 views11 pages

    Biosimilar Development

    Uploaded by

    RAJAN GARG
    This document summarizes Hetero Biopharma's experience developing and commercializing biosimilars in India. It discusses their process which includes clone and cell line development, product development through clinical trials, and commercialization. Key products developed include darbepoetin alfa, rituximab, and bevacizumab. The development of these biosimilars followed Indian regulatory guidelines and included establishing biosimilarity to reference products through analytical, preclinical, and clinical studies. Biosimilars developed by Hetero Biopharma have been approved and commercialized in India to increase access and reduce healthcare costs.

    Copyright:

    © All Rights Reserved
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    of 11

    Biosimilars Development &

    Commercialization Experience

    Presented By: Mahesh HRK


    Vice President
    Corporate Quality Assurance
    Hetero
    India 1
    INTRODUCTION
     A similar biologic product is similar in terms of quality, safety and efficacy to an approved
    reference product based on comparability
     India emerging as a key player in Biosimilars
     In about a decade, India has seen a robust growth in Biosimilars
     India has released Biosimilar guideline in 2012 and revised subsequently in 2016
     This guideline provides Regulatory Pathway for development, manufacturing and
    commercialization of biosimilars
     Biosimilars represent a major change/paradigm shift in terms of innovation, new indications,
    cost and competition
     Biosimilars have large potential comercial opportunities

    2
    Hetero Biopharma Experience in India
     Hetero Biopharma Biosimilar Products developed and commercialized as per following major
    milestones
     Clone/cell line development
     Product development
     Pre-clinical studies
     Clinical studies
     Commercialization
     Post Marketing Surveillance or phase IV studies

    3
    Product Development
     Hetero Biopharma Biosimilar Products are produced in Chinese Hamster Ovary (CHO) cell line
    by recombinant DNA technology; CHO cell line most widely used cell line
     Master cell bank (MCB) and working cell bank (WCB) manufactured under GMP environment
     MCB & WCB are characterized for identity and safety parameters
     Extensive comparative biosimilarity studies were performed against innovator product
     Process development – upstream & downstream development
     Analytical methods development for lot release testing & biosimilarity establishment
     Stability studies for Biosimilar products performed under real time real temperature and
    accelerated conditions

    5
    Product Development
     Biosimilar products are analysed as per in-house specifications
     Extensive characterization using Reference product (at least 3 lots of Reference product)
     Process validation, viral validation and method validation studies have been performed
     Non-infringing process and materials used all through the process & product development

    5
    Pre-clinical development
     Preclinical (in vivo toxicological studies) were conducted to show safety between the biosimilar
    and reference product in rodent species (mice & rats)
     Extensive toxicological investigations were undertaken before a biosimilar taken to the clinical
    evaluation stage

    6
    Clinical development of Biosimilars
     Clinical studies (Phase III) were conducted with reference product to demonstrate PK/PD,
    efficacy and safety including immunogenicity
     All clinically relevant and sensitive study population, endpoints, sample size and study duration
    are chosen to confirm similarity and ruled out clinically meaningful differences
     Clinical study was conducted at internationally accredited CRO’s
     Phase IV studies been initiated for all commercialized products with large number (at least 200)
    of patients in India

    7
    Regulatory pathway in India

    IBSC: Institutional Biosafety Committee


    RCGM: Review Committee on Genetic
    Manipulation
    DCGI: Drug Controller General of India

    Reference: Indian similar biologic


    guideline (2016)
    8
    HETERO Biosimilars
     Commercialized products in India

    S. No. Product Indication (Category) Status

    1. Darbepoetin alfa Nephrology and Oncology Commercialized in 2014

    2. Rituximab Oncology and Rheumatology Commercialized in 2015

    3. Bevacizumab Oncology Commercialized in 2016

    9
    Conclusion
     Hetero Biopharma experience in Biosimilars development complying as per Indian and
    some of the global regulatory guidelines
     The regulatory guidelines will continue to evolve as we get more experienced and
    biosimilars continue to come to the market
     Awareness of the deviations between biosimilars and innovator products in terms of
    efficacy, safety and immunogenicity is essential for proper prescription and safety of
    the patients
     Biosimilars are answer to save medication costs and increase population coverage
    especially in emerging and under developed countries

    10
    THANK YOU
    11

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