Abstract (EN)

Objectives Analyze factors influencing Erythropoietins (EPO) biosimilars (copies of patented EPO) (BIOSIM-EPO) uptakes in key global markets. Identify, if possible, country profiles where BIOSIM-EPO have taken market shares. Methods Countries inclusion criteria: legal definition and regulatory framework for biosimilars close to the EU ones; at least 3 years of experience with BIOSIM-EPO in 2012; national biological market value higher than US$ 2.5 billion. Factors evaluated: national EPO market sizes, EPO retail/hospital distribution mixes, existence of policy incentives that promote BIOSIM-EPO prescriptions or substitution and BIOSIM-EPO prices relative to reference EPO. Data on medicine volumes, values and ex-manufacturer prices for all EPOs (alfa, BIOSIM-EPO (EPO alfa biosimilar), beta and second-generation ones) were provided by IMS Health. Volumes were calculated in DDD (Defined Daily Doses) and prices in euros per DDD. Data were available from 2007 until 2012. Results EU-5 and Japan have been included. Germany: small-sized market, dominant retail market distribution, incentives to prescribe BIOSIM-EPO (quotas) and to substitute patented for ‘bioidenticals’ EPO, high BIOSIM-EPO uptakes (30.4% in 2012). Spain and Italy: medium-sized markets, dominant hospital distribution, no incentives, 11.5% and 8.6% BIOSIM-EPO uptakes respectively. Japan: the largest market, mixed distribution channels, no incentives, 6.8% BIOSIM-EPO uptake. France: large-sized market, dominant retail market distribution, no incentives, 5.8% BIOSIM-EPO uptake. The UK: the smallest market, mixed distribution channels, no incentives, 2.0% BIOSIM-EPO uptake. The price differences between BIOSIM-EPO and their reference play no role at a global level (e.g. -10.8% in Germany and -26.9% in Japan). Conclusions This study proved that EPO markets are highly country specific. There is no single specific profile for countries in which BIOSIM-EPO have significantly penetrated the market. Providing national prescription and substitution incentives is the only determining factor for BIOSIM-EPO uptakes. National EPO market sizes, EPO retail/hospital distribution mixes and BIOSIM-EPO prices relative to reference EPO are not significant factors.