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Immunogenicity and Adverse Reactions to Biosimilar Erythropoietin Products in Thailand: The Significance of Science and Quality Driven Process for Approval

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Biosimilars

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 34))

Abstract

The immunogenicity of recombinant human erythropoietin (r-HuEpo) by subcutaneous exposure has been well described. This adverse immunological effect causes anti-r-HuEpo-associated pure red cell aplasia (PRCA). There have been increasing cases of anti-r-HuEpo-associated PRCA after subcutaneous exposure in Thailand. The casual mechanism of this disease may relate to HLA immunogenic, protein aggregation, stability during storage and handling of drug products, formulation and drug product quality.

The r-HuEpos have been licensed for treatment of renal anemia in Thailand include innovator products and more than 20 biosimilar products. Lack of a scientific product characterization and quality driven process to approve such biosimilars may lead to different immunogenicity and safety profiles. The Prospective Immunogenicity Surveillance Registry of r-HuEpo with Subcutaneous Exposure in Thailand estimated the incidence of anti-r-HuEpo associated PRCA among subjects who had subcutaneous exposure to any r-HuEpo product currently available in Thailand, addressed the risk of anti-r-HuEpo-associated PRCA, and the association of product qualities towards adverse immunogenicity.

The experiences of biosimilar r-HuEpo in Thailand and anti-rHuEpo associated PRCA in Thailand illustrated the need to evaluate biosimilar product on a case-by case basis. Considering patients ‘safety as the first priority, the approval process for biosimilar drug licensing should be designed to assess quality, characterization and impurity profile and comprehensive evaluation of the non-clinical and clinical aspects. Pharmacovigilance could be the final step to narrow the gap between quality and safety and can be assessed in totality with cost-effectiveness and patient benefit that such drug offer.

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Author information

Authors and Affiliations

  1. Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand

    Kearkiat Praditpornsilpa & Kriang Tungsanga

  2. Department of Pharmacology, Faculty of Pharmaceutical Science, Mahidol University, Bangkok, Thailand

    Anunchai Assawamakin

Authors
  1. Kearkiat Praditpornsilpa
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  2. Anunchai Assawamakin
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  3. Kriang Tungsanga
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Correspondence to Kearkiat Praditpornsilpa .

Editor information

Editors and Affiliations

  1. Oncobiologics Inc., Cranbury, NJ, USA

    Hiten J. Gutka

  2. Statistical Sciences, MedImmune LLC, Gaithersburg, MD, USA

    Harry Yang

  3. Novartis (United States), East Hanover, NJ, USA

    Shefali Kakar

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Praditpornsilpa, K., Assawamakin, A., Tungsanga, K. (2018). Immunogenicity and Adverse Reactions to Biosimilar Erythropoietin Products in Thailand: The Significance of Science and Quality Driven Process for Approval. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_25

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