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Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP Posted 09/10/2020

Biopharmaceuticals are large molecules that are far more complex than traditional, chemical pharmaceuticals. With patent expiry for many originators, biosimilar versions are expected to flood the market in the years to come. However, the active pharmaceutical ingredients (APIs) of all such products are manufactured using living systems which means that their manufacture and characterization is also complex.

A recent paper published in GaBI Journal [1] has carried out an in-depth exploration of current biopharmaceutical manufacturing processes [2] and the challenges of manufacturing [3]. It has highlighted that most biopharmaceuticals share similar processes and considerations. However, the inherent variation in quality of product means there is a demand for extensive process and product understanding.

The paper also investigated the need for global harmonization of good manufacturing practice (GMP) standards for biopharmaceuticals adopted by regulatory authorities and international organisations [4]. It found that these are generally similar and appropriate in addressing manufacturing challenges. However, through this, it uncovered various regulatory challenges that stand in the way of global GMP harmonization for biopharmaceuticals [5]. These include the evaluation of biosimilarity, different views on interchangeability and a growing occurrence of data integrity lapses. Solutions suggested in the investigation include the implementation of Industry 4.0, improved harmonization of regulatory efforts and creating a culture of quality within biopharma producing organizations.

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References
1. Sia CH, Sia MK, Chan LW. Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):52-63. doi:10.5639/gabij.2020.0902.010
2. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceuticals and biosimilars: manufacturing processes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Biosimilars/Research/Biopharmaceuticals-and-biosimilars-manufacturing-processes
3. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceuticals and biosimilars: manufacturing challenges [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2]. Available from: www.gabionline.net/Biosimilars/Research/Biopharmaceuticals-and-biosimilars-manufacturing-challenges
4. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceuticals and biosimilars: global harmonization GMP standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2].
5. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization GMP standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 2].

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