HMA Working Group of Biosimilars (BSWG)

The working group will:

• Address specific topics at the request of HMAs, such as information on interchangeability of biosimilars, counteracting misinformation in the market, promoting traceability and pharmacovigilance.
• Ally closely with EMA [Biosimilar Medicinal Products Working Party (BMWP) and EMA Biosimilar Matrix] to facilitate to the flow of information of science and research concerning biosimilars, including registries.
• Support EU Network Training Center (EU-NTC) in collaboration with BMWP in identifying areas where training may be required to ensure the appropriate capability in the network.
• Discuss best practices within the EU network to promote access to biosimilars.
• Respond to requests from NCAs (Q&A, data/publications on specific topics emerging in NCAs).
• Contribute to stakeholder meetings on biosimilars.
• Contribute to the goals of the MAWP focusing on biosimilars.
• Keep HMA informed about its progress and recommendations
• Draft HMA opinions on the use of biosimilars.
• The working group drafts an annual work plan to be agreed upon by the HMAs.

The working group will have annually 3-5 teleconferences and one face to face meeting in the context of a relevant regulatory meeting or conference.

• BSWG is composed of representatives of AT, BE, CZ, DE, EE, ES, FI, GR, IE, IT, LV, NO, SE and SI. A coordinating contact person representing EMA is also invited.
• Acting Chair: Esa Heinonen (FI)
• Vice-chair: Steffen Thirstrup (EMA)
• Scientific secretariat: Ingrid Bourges (BE) and Niklas Ekman (FI)

Contact Point:

Hallin Charlotte - charlotte.hallinnoSpam@noSpamema.europanoSpam.eu

The group has 4-5 TCs and one face-to-face meeting annually. The main aim of the group is share best practices and tactics to enhance the uptake of biosimilars. Country reviews have been carried out for almost all member countries, and two countries which are not members (Denmark and Switzerland). The national policies have included information campaigns, gains sharing arrangements, prescription policies, procurement arrangements for biological medicines, pricing policies and changes of legislation at national level (e.g. on automatic substitution).

The group has gone through market analysis of biosimilars (e.g. IQVIA reports) on the uptake of biosimilars, savings gained and increase of patients treated with biological medicines; and discussed about the factors hindering the uptake of biosimilars.

The group has also started collaboration with the members of the NCAPR (pricing and reimbursement).

The group has also written some significant articles on regulatory aspects of biosimilars e.g. on interchangeability of biosimilars of monoclonal antibodies.

The group made an analysis of the information on the websites of NCA in 2021 and found out that in 10 agencies information was totally missing. A minimum set of information was recommended and endorsed by the HMA plenary. A new analysis 9/2023 showed that only two agencies was lacking the minimum information after this intervention.

The group also requested to have a statement on interchangeability between biosimilar and originator products on the website of EMA, and this statement was then published 9/2022. This statement has had significant effects on the trust of biosimilars in EU.

The group made an extensive analysis on the information on biosimilars for patients and health care professionals at the websites of EMA, NCAs, FDA and other health authorities. Based on this analysis the recommendation is to update the information at the website of EMA. This will form a TOOL KIT (including also videos and infographs in various languages) which could be then used in information campaigns at EU and national levels.

The group has actively contributed to some international meetings on biosimilars and shared opinions on future requirements of biosimilar development.