The uptake of biosimilars in different countries was a subject discussed by both Dr Jaclyn Bosco and Mr Murray Aitken of IQVIA.

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).

The European Commission (EC) and the European Medicines Agency (EMA) have published an information guide on biosimilars aimed at healthcare professionals in 23 languages.

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 [1] 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 [1] 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.

Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example of an economic evaluation of the benefits of generics was published in Current Oncology [1].

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.

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

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: