More Articles

FDA denies Novo Nordisk petition to block generic liraglutide Generics/General | Posted 02/02/2018

On 5 January 2018, the US Food and Drug Administration (FDA) denied Novo Nordisk’s October 2017 citizen petition [1] that sought to block generic versions of its insulin Victoza (liraglutide) and t...

National experience with public procurement of biosimilars Reports | Posted 26/01/2018

In the third Multi-stakeholder Workshop on Biosimilar Medicinal Products organized by the European Commission [1], it included a session on ‘Biological Medicines Access Mechanisms: Balancing Access...

Hospitals to start own generics company Generics/News | Posted 26/01/2018

In an effort to combat regular shortages and the increasing prices of drugs, four of the US’s largest hospital systems have made plans to create a non-profit generics company.

France aims to reach 80% biosimilar penetration by 2022 Policies & Legislation | Posted 26/01/2018

In the coming years France intends to promote the use of biosimilars and is aiming to reach 80% biosimilar penetration by 2022.

Mylan/Momenta announce development strategy for aflibercept biosimilar Biosimilars/General | Posted 26/01/2018

US generics giant Mylan and partner Momenta Pharmaceuticals announced on 3 January 2017 their development strategy for their aflibercept biosimilar, M710.

Trastuzumab biosimilars receive EMA and ANVISA approval Biosimilars/News | Posted 26/01/2018

Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.

Switching to biosimilars in rheumatology Biosimilars/Research | Posted 26/01/2018

Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].

EMA accepts application for pegfilgrastim biosimilar from USV Biosimilars/News | Posted 26/01/2018

India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Med...