Position paper on biosimilar medicines

Position paper

Ivana Silva from EMA approached me regarding our Biosimilar position paper. She was very happy that we adopted the position paper. However, she also informed me that EMA was surprised that we used the Commission Q&A document of 2012 as a reference for defining the term “biosimilar medicine” (footnote 1 of our position paper) and the Commission Consensus Information Document of 2013 for the terms mentioned in the section on interchangeability, switching and substation of biosimilar medicines (footnotes 7, 10 and 11 of our position paper) instead of the newly adopted Guide for Healthcare Professionals.

The Guidelines for Healthcare Professionals that were released by EMA and the European Commission were made public only after we had finished the drafting process of the position paper. Due to this we had to rely on older documents.

In light of the importance of our position paper, Ivana inquired during our call if there is a possibility to update the position paper in order to include the Guide for Healthcare Professionals as a reference. In addition, Ivana would also be interested in including a reference to the Guide for Healthcare Professionals in relation to the section on “information on biosimilar medicines” since the Guide addresses the terms and concepts mentioned in this section of our position paper. After our call Ivana also provided me with her comments in writing HERE

Changes to the definition of “biosimilar medicine” have been introduced in the position paper (HERE) in order to illustrate the type of modification that would be required if we comply with EMAs request. Further changes would be necessary regarding the definitions of “interchangeability”, “switching” and “substitution”. These changes similar to the one in the example would entail modifying the text of the definition as well as the footnote.

Ivana’s second request would entail adding an additional footnote in the section “information on biosimilar medicines” which cross-refers to the Guide for Healthcare Professionals.

The board needs to determine if we could update the position paper in accordance with EMA’s request.

Commission Biosimilars event 2018

On 7th September the Commission held its kick-off meeting for the next multi-stakeholder biosimilar workshop. I could not attend this meeting, since EPHA’s annual conference took place on the same day. During the meeting the following was dicussed.

1. Date of 2018 event – 14 September 2018
   The original plan to organise the event again in May-June had to be skipped due to major competing events (ASCO, MfE Biosimilars Conference, etc) and holidays during these months. Following discussions and the check of room availability the new date is Friday, 14 September 2018
2. Topics/format
   During the last weeks stakeholders sent their inputs on interesting topics. Following a tour de table and discussion there is an agreement to organise 3 sessions on:
   Oncology – new developments, clinical experience, what is expected; view of patients and healthcare professionals
   Procurement – build on this year’s session – implementation of procurement directive and its impact, new models in different Member States, etc.
   Education & Information – special focus on specialist nurses and hospital pharmacists, their curriculum in different Member States, etc. The Commission asked for volunteers (2 organisations per session) for co-ordination of the sessions
3.  New stakeholders
   If we have oncology as one of the topics, would be important to mobilize cancer organisations. Kaisa suggested: European Cancer Patient Coalition (Lydia Makaroff), Europa Donna (http://www.europadonna.org/ , Susan Knox, Karen Benn), Europacolon (http://www.europacolon.com/ , Yola Gore-Booth, Geoffrey Henning), Lung Cancer Europe (http://www.lungcancereurope.eu EPF contact is Ewelina Szmytke (Vice-President)). More suggestions are welcome.
4. Q&A on biosimilars for patients: State of play proof reading translations
   The Commission received over the summer comments on the translations. The table indicates which language version has been proof read by which organisation. (Dark green: published; green: at least 2 proof read versions; light green: 1 proof read version; white: no proof read version received). We are looking for a solution who could consolidate the language versions where we received 2 or 3 proof read docs with comments: Czech, Danish (I will ask Tina Engraff), Croatian (EFCCA will consolidate), Hungarian (I consolidated), Lithuanian, Romanian, Slovenian, Swedish (Gustaf Befrits consolidated the 3 proof read docs).

The Commission requested to receive input/information on the following by 2nd October:

• interest to co-ordinate one of the sessions
• input on other associations we could involve/invite
• ideas how we could consolidate the language versions of the Q&A where the Commission received 2-3 commented docs

Medicines for Europe already suggested 1 coordinator for each topic from within the organisation (1. Oncology – Maarten van Baelen, 2. Procurement – Wojciech and 3. Education & Information session – Erika). Moreover, ESNO followed up on the inclusion of the specialised nurses – which was also discussed during the meeting – and suggested Liesbeth Moortgat of European IBD nurses as keynote speaker and co-coordinator of one session in which nurses are involved.

I discussed the event shortly with András and he suggested our involvement in the procurement session.