The full version of this biosimilars feature can be read in the August issue of our digital magazine: http://www.pharmtech.com/ptedigital0810
What is the EGA's involvement in improving access to and the quality of biosimilars?
In the context of biosimilar medicines, the EGA has been and continues to be a key stakeholder for the EU institutions, including
the European Medicines Agency, as well as a key discussion partner for the World Health Organisation (WHO).
The EGA, together with its members involved in developing biosimilar medicines, has contributed very actively to the key milestones
achieved to date:
- a robust legal and regulatory framework, guided by science
- clarification regarding the same International Non-proprietary Name (INN) as for the reference product
- WHO guidelines on the evaluation of similar biotherapeutic products, based on the same scientific principles as in the EU
- clear identification of all biopharmaceuticals by the approved name and the batch number for the purpose of suspected adverse
It is also important to point out that the term 'biosimilar' is derived from EU legislation, which refers to similar biological
medicinal products. Consequently, the term 'biosimilar' should only be applied to biopharmaceuticals that have been approved
in accordance with the EU legal basis and data requirements, or following a rigorous and extensive comparability exercise
at quality, non-clinical and clinical level with an ICH standard reference product, as required in the EU.
Non-originator 'copy' biopharmaceuticals worldwide are often labelled as 'biosimilars' despite the lack of thorough comparability
at all levels with an ICH standard reference product. This has led to confusion, misinterpretation of the EU biosimilar concept
and to unsubstantiated fears about safety. Given the high data requirements in the EU, these products would consequently not
receive approval from the European Commission (EC).
The EU regulatory framework has already inspired — and is continuing to inspire — many countries and we will continue to promote
these high quality and safety standards worldwide. The EU legal framework also offers the key advantage of separating patent
litigation from the regulatory approval processes. By doing so, it allows timely access to competitively-priced biosimilar
Do you believe pharmacovigilance legislation should be enforced to monitor safety?
Pharmacovigilance rules are necessary for the protection of public health to detect, assess and prevent adverse effects of
all medicinal products placed on the EU market. New improved pharmacovigilance rules have now been signed off during the Spanish
Presidency between the three EU institutions (the European Parliament, the Council and the EC) and are expected to be formally
adopted during Autumn 2010. These rules shall apply 18 months after publication in the Official Journal of the European Union.1,2
There are no specific provisions regarding biosimilar medicines because such products are approved by the EC based on the
same benefit/risk criteria as any other biopharmaceutical. It is important to highlight that immunogenicity is not a specific
concern for biosimilar medicines because all biopharmaceuticals, in contrast to conventional pharmaceuticals, are polypeptides
or proteins and demonstrate a greater capacity to elicit an immune reaction. Immunogenicity may be influenced by factors relating
to the medicine itself, such as the manufacturing process and formulation, and also by factors related to the individual susceptibility
of a patient, the disease and the treatment method, including the immune status of cancer patients, and the route of administration.3 Because of these concerns, any biological medicinal product, approved after the enforcement of the new pharmacovigilance
legislation will be subject to additional monitoring activities.
The European Medicines Agency, with the member states, will set up a list of products subject to additional monitoring. This
list will include the names and active substances of future products that contain a new active substance as well as any future
biological product, but other products may also be added to the list. There will also be an electronic link to the product
information and the summary of the risk management plan (RMP). These products will have a black symbol in their product information
and a standard sentence that invites the reporting of all adverse events. Any product specific additional monitoring activity
will be listed in the RMP.