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.
Members and Representatives
- 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)
Hallin Charlotte - charlotte.hallin@ ema.europa .eu