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EMA Guideline on similar Biological Medicinal Products adopted

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EMA Guideline on similar Biological Medicinal Products adopted
On 23 October, the CHMP adopted the revised Guideline on similar biological medicinal products. Get more details here.

Last year the “Draft Guideline on Similar Biological Medicinal Products” was published by EMA.
After agreement of the revised draft by the Biosimilar Medicinal Products Working Party and Biologics Working Party in July, the CHMP adopted and published the final Guideline on 23 October 2014. They summarized the outline of the document as follows:
“This Guideline outlines the general principles to be applied for similar biological medicinal products (also known as biosimilars) as referred to in Directive 2001/83/EC, as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.
This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.

The scope of the guideline is to fulfil the requirement of section 4, Part II, Annex I to Directive 2001/83/EC, as amended, which states that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’.”
The date for coming into effect is 30 April 2015 (with the advice: After adoption by CHMP applicants may apply some or all provisions of this guideline in advance of this date.). The document replaces the Guideline on similar biological medicinal products (CHMP/437/04).
For further infromation please see the complete “Guideline on similar biological medicinal products“.
ICH gets new Members and informs about the ICH Q3D Implementation

ICH gets new Members and informs about the ICH Q3D Implementation
The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. Read more about the current decisions of the ICH Steering Committees.
ICH gets new Members and informs about the ICH Q3D Implementation\
The International Conference on Harmonisation (ICH) is the most significant organisation for the harmonisation of requirements with regard to the authorisation and the manufacture of medicinal products. The ICH wants this function to be extended. For that reason – during the last meeting in Minneapolis, USA – the Steering Committee decided to welcome two new members. Beside the American FDA, the EMA/EU Commission and the Japanese Authority belong to the founding members. Now, the Swiss Authority Swissmedic and the Canadian one (Health Canada) have joined the ICH Board.
Another important notice has been announced after the meeting in Minneapolis. In September 2014, the harmonised Guideline ICH Q3D Elemental Impurities will reach the Step 4 status. The FDA as well as the EMA/EU Commission and the Japanese MHLW will take over the whole document into their respective national regulations. This last – and formal – procedure will be defined as Step 5. No changes will be made in the guidance document when the authorities will make the transfer to the regulatory framework.
The new ICH Q3D and the recently adopted ICH M7 (Genotoxic Impurities) will therefore be addressed at the international Impurities Forum in Berlin.
Source: Press Release of the ICH Meeting in Minneapolis
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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