Biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn, this leads to complex manufacturing processes. A recent GaBI Journal [1] article by Sia et al. has investigated the good manufacturing practice (GMP) standards of various global regulatory authorities (RAs) and international organisations (IOs). It has revealed that we are well on the way to global harmonization of GMP standards that will help bring these products to more people across the globe.
The need for GMP harmonization
With the expiration of many patents of biopharmaceutical products, it is expected that there will now be a rise in the production of biosimilar products available. Due to the complex nature of biopharmaceuticals and biosimilars, production methods are complex [2] and face a number of challenges [3]. In addition, they are sensitive to physical and chemical conditions and these must be monitored to ensure the product’s quality, safety and efficacy. As such, it is vital to adopt appropriate GMP guidelines when manufacturing biopharmaceuticals to safeguard public health. It is important to ensure that the GMP guidelines adhered to in the countries that supply raw materials for production are in line with those producing the biosimilar.
Sia et al. noted that, to date, there has been review of the biopharmaceutical regulatory frameworks of western countries, such as Canada and the US, and some Asian countries. However, few studies have covered frameworks in the Association of South East Asian Nations (ASEAN). At present, ASEAN provides many incentives for biopharmaceutical manufacturers, such as low manufacturing cost and the provision of a large market (combined population c. 600 million). As such, it is important to ensure adequate GMP guidelines are adopted in the countries of this region.
Sia et al. found that most IOs and RAs currently adopt similar GMP principles, showing a significant level of harmonization globally. Despite this, the authors highlight some discrepancies, for example, between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the World Health Organization (WHO). In addition, in China and India, some GMP guidelines do not seem specifically relevant to biopharmaceuticals. However, it notes that these nations are undergoing reform and may join PIC/S.
The author also highlight that review of the ASEAN GMP standards has revealed that many of these nations adopt PIC/S GMP recommendations for biopharmaceuticals. It points out that the lack of unified adoption is likely due to the exclusion of biopharmaceuticals from the scope of the ASEAN Mutual Recognition Arrangement (MRA). Processes are underway to include biopharmaceuticals in the future.
Regulatory challenges
Sia et al. emphasized that the outlook of GMP harmonization for biopharmaceuticals is promising. As this occurs, there will be greater assurance of quality and safety of biopharmaceuticals. The authors highlight and suggest solutions for various regulatory challenges [4] and stresses that more effort is needed to provide guidelines on the interchangeability of biosimilars, to encourage their use.
Related article
Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP
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 Nov 20]. 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 Nov 20]. Available from: www.gabionline.net/Biosimilars/Research/Biopharmaceuticals-and-biosimilars-manufacturing-challenges
4. GaBI Online - Generics and Biosimilars Initiative. Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization of GMP standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 16]. Available from: www.gabionline.net/Biosimilars/Research/Biopharmaceuticals-and-biosimilars-regulatory-challenges-for-global-harmonization-of-GMP-standards
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