What does the Biopharmaceutical industry include?
Biopharmaceuticals are either medical products with biological sources, or are produced by bioprocessing techniques, such as gene and protein expression. Typical biopharmaceuticals include:
- monoclonal antibodies
- antisense drugs
- cell therapy products
- stem cell / Advanced Therapeutic Medicinal Products (ATMPs)
The registration of biopharmaceuticals and their governing bodies
Biopharmaceuticals are subject to the same process of registration as pharmaceutical products. For rDNA technology, controlled expression of genes, hybridomas and monoclonal antibodies, a Centralised Application (CP) is mandatory in Europe. There are also other non-standard approval routes for biologics in the EU, UK, and US such as orphan drug products, conditional approval, approval under exceptional circumstances, and accelerated review.
Regardless of the route of registration, the level of detail required to be filed for biopharmaceuticals (particularly in m3 of the dossier) is significantly greater than that required for pharmaceutical products; the information is organised in the same manner as for pharmaceutical products.
The development of biopharmaceutical products has a significantly high failure rate and typical pressure-points include longer and more stringent clinical trials and a slow technology transfer to scale-up the manufacturing process. The intrinsic variability in biopharmaceuticals (including the variability in the tests used for analysis) adds an additional level of complexity in justifying and defining specifications.
The regulatory bodies responsible for governing biopharmaceuticals are the same as for pharmaceutical products and include both National and regional organisations such as the Food and Drug Administration (FDA) in the US, the Medicine and Healthcare Product Regulatory Agency (MHRA) in the UK, and the European Medicines Agency (EMA). There are some additional specialist agencies such as FDA’s Centre for Biologics Evaluation and Research (CBER) and the National Institute for Biological Standards and Controls (NIBSC) in the UK that are dedicated to the regulation and approval of biological products.
Recent trends in biopharmaceuticals
Over recent years the biopharmaceuticals sector has moved towards the development and registration of biosimilar products (also referred to as “follow-on biologics”). The EU has taken the lead in the development of legislation for the successful approval of the wide range of biosimilar products with the FDA following with the approval of biosimilars in the USA. In developing biosimilar products, manufacturers must overcome significant challenges in demonstrating equivalent efficacy, safety, and interchangeability profiles.
Other developments include platform technologies that can be applied to the manufacturing process of more than one biopharmaceutical. This may include the use of bacterial and viral vectors for the manufacture of vaccines. Fundamental to the development of all biological and biosimilar products are clear protocols for scale-up, including compliance to cGLP and cGMP, and robust non-clinical and clinical programmes that are based around the intended use and that are needed to secure product licensure.
Rigorous validation of the entire manufacturing process, with special attention to the potential of unwanted side effects (such as immunogenicity against impurities and degradation products), form a critical part of the development and registration process for this highly specialised area of pharmaceuticals.
Need further information?
Woodley BioReg was founded on the industry’s needs for specialised sector knowledge to navigate the highly detailed regulations and guidance around biopharmaceuticals. The nature of biopharmaceuticals means that operators in this area need highly specialised training and expertise gained over many years. For this reason, it is generally not considered possible to transition pharmaceutical regulations to biopharmaceuticals.
Woodley BioReg has over 200 years combined experience in supporting the development of biopharmaceutical products, including process development, validation, comparability/biochemical bridging, nonclinical and clinical development, agency interactions, and submission and maintenance of Product Licences for a number of biopharmaceuticals and vaccines throughout Europe and the US. Woodley BioReg has supported a number of biologics manufacturers through a flexible resourcing solution to address immediate and long term strategy, regulatory, and quality needs.