CNMC study on the wholesale medicines market in Spain: biosimilar medicines

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The National Commission for Markets and Competition (Commission Nacional de los Mercados y la Competencia, CNMC), the body that promotes and preserves the proper functioning of all markets in the interest of consumers and businesses in Spain, published on 22 June 2022 a study on the regulation of medicine prices in the country, which analyses its main problems and puts forward several recommendations to improve the functioning of the sector, including that of biosimilars, for the benefit of consumers and public health. The research focused on medicines sold through pharmacies. 

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The study identified several areas where regulation does not sufficiently exploit competition mechanisms and proposes a review of regulation to achieve cheaper medicines and more effective competition between laboratories and in the distribution channel. The study thus advocates for regulation that stimulates competition between originator, generic and biosimilar medicines by proposing reforms in the pricing of medicines financed in competition (the ‘reference price system’ and ‘reference sets’) and also advocates facilitating the market entry of generics and biosimilars.

Biosimilars are a source of competition for originator medicines. But as they are not absolutely equivalent to the originator medicines, but have slight physicochemical and biological differences, the study calls on the competent authorities to clarify, on the basis of clinical evidence, whether it is safe for patients to exchange a biological for a biosimilar during treatment.

The CNMC's final recommendations on biosimilars are based on strengthening the analysis and attention to the evidence on the interchangeability of biosimilars with biological medicines in order to assess positions on this issue, as well as developing more information and health education campaigns on biosimilar medicines.

This is the second study prepared by the CNMC, continuing the line of work that began in 2015 with the publication of the Market Study on the Retail Distribution of Medicines in Spain.

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Reference
1. Comision Nacional de los Mercados y la Competencia. Estudio sobre el mercado de distribución mayorista de medicamentos E/CNMC/002/17. 2022 [homepage on the Internet]. [cited 2022 Oct 21]. Available from: https://www.cnmc.es/sites/default/files/4327509.pdf 

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