Dr Elena Wolff-Holz, from the Paul Ehrlich Institut and Federal Agency for Vaccines and Biomedicines, and Chair of the Biosimilar Medicines Working Party at the European Medicines Agency (EMA), gave a presentation on EMA initiatives with respect to biosimilars. The conference was held on 26−27 April 2018 in London, UK and as part of her presentation Dr Wolff-Holz discussed cases where a full or a modified clinical programme was required for approval of biosimilars [1].
Original Article: Full or modified clinical programme for biosimilars