The Generics and Biosimilars Initiative’s second Middle East and North Africa (MENA) Stakeholder Meeting on Regulatory Approval, Clinical Settings, Interchangeability and Pharmacovigilance of Biosimilars  opened with an introduction to United Arab Emirates’ (UAE) National Strategy for Innovation.
The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper  using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.
In a presentation on ‘Biosimilar Considerations for Real World Research and Stakeholder Questions’ at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 23‒24 September 2019 in Bethesda, Maryland, USA, considerations for real-world research on biosimilars were discussed by Dr Jaclyn Bosco of IQVIA. These include: