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Another adalimumab copy biological accepted for review in China posted 16/11/2018

The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another ap...

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...

 

Research

Phase I study suggests similarity of omalizumab biosimilar posted 16/11/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest...

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...

 

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...