There are many challenges still facing Chinese companies when it comes to getting copy biologicals onto the market. Such challenges include creating a strong manufacturing and distribution infrastructure, which is essential for the successful launch of copy biologicals.
Manufacturing
Manufacturing of biologicals is more challenging than for traditional small molecule drugs. Biologicals are large and complex, often consisting of heterogeneous mixtures. They are generally made in genetically engineered cells that impose their own variabilities – in post-translation modifications such as glycosylation – on the processes used to make such drugs. This can produce challenges when manufacturing biologicals, as even minor changes in manufacturing process can cause significant changes in efficacy or immunogenicity [1].
Complicated manufacturing processes lead to an increase in costs. For example, Innovent has indicated that large biologicals manufacturing facilities require upward of US$200–US$700 million to build, compared with only US$30–US$100 million for small molecule facilities of a similar scale. Such costs could present a major hurdle for Chinese companies. There is also a lack of capacity at contract research organizations (CROs), whose facilities are mostly pilot scale, designed for preclinical or clinical trial usage, and have not yet demonstrated their ability to handle full-scale commercial good manufacturing practice (GMP) production. Therefore, manufacturing is an area requiring significant investment.
Distribution
Once the copy biologicals have been developed, approved by regulators and produced on a commercial scale, they still need to be distributed to hospitals and patients.
Experience from Europe and the US has shown that the success of the biosimilar market is closely linked to the creation of a strong commercial ecosystem that informs physicians and patients of this new therapeutic class and ensures the availability of drugs through an efficient supply chain.
Currently, China’s marketing and distribution system still lacks transparency. For example, when it comes to the prescription drug model, rebates and other reward systems can heavily influence physicians’ decision-making and potentially increase the risk of overcharging end-users/patients.
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Small molecule versus biological drugs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs
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