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

Home/Reports | Posted 21/10/2022 post-comment0 Post your comment

The National Commission for Markets and Competition (Comisión 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. 

Health Budget 2

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.

Related articles
Survey results of biosimilars use among Spanish physicians and pharmacists 

Benefits of innovative biologicals and biosimilars for patients and health systems

Use of biosimilars generates savings in the Spanish health budget of 2021

Biosimilars in Spain: balance between innovation and health public expenditure

LATIN AMERICAN FORUM

The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO

Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Actualizaciones de las monografías de la Farmacopea Europea sobre productos bioterapéuticos

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

  

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 

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010