Supply chain shortages of key medicines in Europe are being aggravated by pharmaceutical companies that choose not to license biosimilars in smaller countries because they see demonstrating clinical bioequivalence as too expensive and risky. This is causing a biosimilar bottleneck that puts pressure on national health service budgets and threatens to restrict access to front-line biological therapeutics as they reach patent expiry.
Barriers to biosimilar approval
All medicines in Europe are licensed at a national level, and pharmaceutical countries need to invest significant sums before entering each country’s market, while running the risk of not achieving regulatory approval for their biosimilars. The cost of batches for the bioequivalence process of regulation can be very high, as is the investment needed for Phase 3 clinical trials. As a result the list of medicines that lack national license approval is a growing problem in several smaller European countries.
A pan-European license won’t solve the whole problem
A pan-European licensing process is a first step to improving access to approved medicines across all member states. The large population size of the EU provides an incentive for companies to go through the licensing process. One immediate benefit may be reductions in the potentially dangerous use of unlicensed medicines that has become a feature of some EU countries such as Ireland. On the other hand, an EU-wide license is less likely to encourage new biosimilars to embark on the long and costly bioequivalence regulatory process.
A new regulatory approach to stimulate innovation
The UK regulator, Medicines and Healthcare Products Regulatory Agency (MRHA), addresses biosimilars on a case-by-case basis, drawing on historical experience and knowledge of the original reference molecule. Any decision to require Phase 3 clinical testing depends therefore on the merits of the biosimilar being submitted for approval. If the EU adopted a similar approach, biosimilar development and innovation could be encouraged more widely, especially in view of recent advances in QTL technology that enable the optimisation of biosimilar manufacturing processes.
QTL technology can expand biosimilar production
QTL technology utilises the power of genomics and the evolutionary capabilities of breeding to generate production strains optimised for the manufacture of specific proteins and peptides using simple and robust bioprocesses. This allows for greater consistency and process control for each specific biological therapeutics being manufactured.
The process is undertaken in the model eukaryote, Saccharomyces cerevisiae (baker’s yeast), making the costs of batch production significantly lower. The lower costs of QTL-enabled biosimilars combined with faster time-to-market provide a significant commercial advantage. QTL technology also enables new intellectual property to be created, extending patent protection even for biosimilars. Obtaining regulatory approval from the MHRA then puts biosimilars in a stronger position to gain approval from the EMA and access the wider European market.
Improving access to affordable medicines across the EU
QTL technology, combined with the regulatory stance taken by the MHRA, promises to reduce healthcare costs by stimulating competition and lowering prices. This new approach has the potential to create alternative supply chains that are more robust while increasing availability to critical biological therapeutics across Europe. Stimulating innovation is another benefit. QTL technology is currently optimising the production of unglycosylated biosimilars, and a research program is already underway for the manufacture of monoclonal antibodies and other glycoproteins.
