Home / Biosimilars

Biosimilars

News

FDA approves adalimumab and pegfilgrastim biosimilars posted 12/11/2018

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab...

Turkey 2016 COVER V16E31DG Adalimumab biosimilars Amgevita and Imraldi launched in Europe posted 12/11/2018

In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launc...

22119008_l Trastuzumab similar biologic Hervycta launched in India posted 02/11/2018

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product He...

18794124_l Mylan gains nod for Ogivri and launches Hulio in Europe posted 02/11/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 Oc...

Turkey 2016 COVER V16E31DG FDA reviews adalimumab biosimilar SB5 posted 02/11/2018

Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) ha...

 

Research

Inflectra may not be less expensive than Remicade in US posted 12/11/2018

According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moder...

Phase III study of biosimilar pegfilgrastim confirms safety and effectiveness in patients on myelosuppressive chemotherapy posted 12/11/2018

Canada-based Apobiologix, a division of Apotex, reported results of an international, phase III, randomized, double-blind cli...

Real-life clinical effectiveness of Razumab in retinal vein occlusion posted 12/11/2018

Authors from Intas Pharmaceuticals presented data from a subgroup analysis of the RE-ENACT study (retrospective, multicentre,...

Clinical and real-world data for switching to biosimilars posted 02/11/2018

The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) t...

AA010968 Mass spectrometry comparison of Remicade and Remsima posted 02/11/2018

The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim b...

 

General

Brazil to remove backlog for generics posted 09/11/2018

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) announced on 3 October 2018 that it w...

20893354_l Merck gains US infliximab contract but drops insulin glargine biosimilar posted 02/11/2018

US pharma giant Merck (known as MSD outside the US and Canada) has signed a deal with the US Department of Veterans Affairs (...

Originator biologicals and biosimilars under attack in UK and Japan posted 26/10/2018

Originator biologicals makers and biosimilars makers are finding themselves facing litigation in both the UK and Japan.

Comments on FDA’s public meeting on biosimilars posted 25/10/2018

Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeabi...

Biocon’s biosimilars plant gains clearance from FDA posted 25/10/2018

India-based biologicals specialist Biocon has stated that its biosimilars plant has received a clean bill of health, indicati...