New guidelines for development and approval of biosimilars move closer
EuropaBio welcomes the direct dialogue and calls upon the EU to settle all outstanding important issues before the first biosimilars enter the market
EuropaBio 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). An EMEA/DIA Workshop has offered all stakeholders, including the industry, the opportunity to present comments on the recently released draft EMEA/CHMP guidelines on biosimilars. 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.
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.
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