New Guidelines For Development And Approval Of Biosimilars Move Closer, Europe

Main Category: Pharma Industry / Biotech Industry
Article Date: 12 Dec 2005 - 18:00 PDT

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EuropaBio, the European Association for Bioindustries, welcomes the initiative of the EMEA to publicly debate and engage in a direct dialogue on the development and approval of similar biological medicinal products (biosimilars). The EMEA/DIA Workshop (1) has offered all stakeholders, including the industry, the opportunity to present comments on the recently released draft EMEA/CHMP guidelines on biosimilars (2). The conference has also demonstrated the EMEA's willingness to finalise these guidelines in a transparent manner, which is most appreciated.

EuropaBio also appreciates EMEA's comments recognising that other stakeholders, such as physicians and patients should become more involved and informed about the issues around biosimilars.

However, EuropaBio believes that there are still important issues to be discussed in a transparent manner in order to ensure that biosimilars will be used safely and effectively, including the need for a unique name and label for a biosimilar. Clear and distinct labelling is essential to avoid confusion between the innovator product and a biosimilar and to facilitate pharmacovigilance obligations.

Dr. Andrea Rappagliosi - Chairman of the EuropaBio Healthcare Council and Member of the Programme Committee of the EMEA/DIA Joint Workshop said: "EuropaBio is confident that this conference will allow the EMEA to finalise the sound and science based guidelines and we look forward to further discussions on the outstanding issues".

EuropaBio therefore calls on the EU to further consider these important issues in the run-up to the issuance of the finalised guidelines, expected in the first semester of 2006, and before the approval of the first biosimilar medicines.

(1) EMEA/DIA Joint Workshop programme

(2) Guidelines

Adopted

a) So called overarching guideline on similar biological medicinal products (CHMP/437/04) members.europabio.org/Groups/welcome-Biosimilars.htm

Guidelines in consultation

a) Guideline on the quality issues to be considered for the development of similar biological medicinal products (EMEA/CHMP/BWP/49348/2005)

b) Guideline on the non-clinical and clinical issues to be considered for the development of similar biological medicinal products (EMEA/CHMP/42832/2005)

c) Guidelines for the development of similar biological medicinal products containing

i. recombinant human insulin (EMEA/CHMP/32775/2005)
ii. Somatropin (EMEA/CHMP/94528/2005).
iii. recombinant human granulocyte colony stimulating factor (EMEA/CHMP/31329/05)
iv. recombinant human erythropoietin (EMEA/CHMP/94526/05)

EuropaBio comments on Draft Guidelines on Similar Biological Medicinal Products
October 2005
europabio.org/positions/4283205.pdf
February 2005
europabio.org/documents/biosimilars.pdf

EuropaBio fact sheet on Biologicals and Biosimilar Medicines:
europabio.org/documents/FS-Biosimilar.pdf

About EuropaBio

EuropaBio, the European Association for Bioindustries, has 60 corporate members operating worldwide and 25 national biotechnology associations representing some 1500 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products.

www.europabio.org