📜 The high cost and risk of demonstrating clinical bioequivalence prevent companies from seeking regulatory approval for biosimilars.
🌍 A pan-European license could improve access to approved medicines, but may not encourage new biosimilars due to the costly regulatory process.
💡 The UK regulator, MRHA, takes a case-by-case approach to biosimilars, encouraging innovation and reducing costs.
⚙️ QTL technology can optimize biosimilar manufacturing processes, lower production costs, and increase availability of affordable medicines across the EU.
Introduction:
The article discusses the issue of supply chain shortages of key medicines in Europe due to pharmaceutical companies opting not to license biosimilars in smaller countries. This lack of licensing is primarily driven by concerns about the high cost and risk associated with demonstrating bioequivalence. The resulting biosimilar bottleneck strains national health service budgets and poses a threat to access to biological therapeutics as their patents expire.
- The cost of obtaining national license approval for biosimilars is high, making it a deterrent for pharmaceutical companies, particularly in smaller European countries.
- A pan-European licensing process could help improve access to approved medicines across member states, but it may not encourage new biosimilar development due to the high costs and regulatory requirements.
- The UK regulator, Medicines and Healthcare Products Regulatory Agency (MRHA), takes a case-by-case approach to biosimilars, considering the merits of each submission. This approach could encourage biosimilar development and innovation.
- QTL technology, which optimizes biosimilar manufacturing processes, can lower production costs and expedite time-to-market, potentially stimulating innovation and expanding biosimilar production.
- The combination of QTL technology and the regulatory approach taken by the MHRA has the potential to reduce healthcare costs, improve supply chain robustness, and increase availability of critical biological therapeutics in Europe.
Conclusion:
The biosimilar bottleneck in Europe, caused by the reluctance of pharmaceutical companies to license biosimilars in smaller countries, poses a threat to access to essential medicines and strains national health service budgets. A pan-European licensing process and the adoption of a case-by-case regulatory approach, as demonstrated by the MHRA in the UK, could encourage biosimilar development and innovation. Additionally, QTL technology offers the potential to lower production costs and expedite time-to-market, further improving access to affordable medicines in Europe.
