2023-01-23-艾昆纬-15年以上的欧洲生物模拟经验（英）_58页_4mb

Summary

Biosimilars are essential for reducing healthcare costs and improving patient access to biologic therapies, playing a key role in sustaining healthcare systems amid rising costs and therapeutic advancements. Omnitrope® (the first biosimilar approved in Europe in 2006 for somatropin) exemplifies this potential, demonstrating high similarity to Genotropin in clinical studies and post-marketing surveillance, with consistent safety and efficacy profiles across pediatric and adult indications.

Over its 15-year availability in Europe, Omnitrope has contributed over $1.9 billion in savings at a list price level in selected countries by lowering costs and increasing competitive pressure on reference medicines. Annual somatropin costs increased by 34%, but usage doubled, aided by its reduced pricing. Savings vary across countries: France recorded $670 million, the UK $287 million, and Spain $230 million, reflecting differences in biosimilar uptake, regulations, and competitive responses.

Country-specific analyses highlight variability in Omnitrope's adoption—e.g., Denmark and Poland show high usage, while others like the Netherlands had initial decreases, suggesting factors like prescriber knowledge, policies, and country-specific market dynamics influence uptake. Omnitrope's uptake has been slower than recent biosimilars in some regions, indicating opportunities for greater savings.

Biosimilars, including Omnitrope, can fund innovative treatments and enhance care for rare diseases, but they face challenges such as policy decisions and ensuring trust among prescribers. Optimizing biosimilar use, particularly through physician education and transparent reporting of savings, is vital for global healthcare sustainability, especially with over 120 biologics losing exclusivity by 2029. Omnitrope's experience underscores the need for a sustainable ecosystem that maximizes savings and improves patient outcomes.