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FDA extends comment period for interchangeability guidance Guidelines | Posted 24/03/2017

In a Federal Register notice published on 15 March 2017 the US Food and Drug Administration (FDA) announced that it would be extending the comment period on its draft guidance on the interchangeabi...

Amgen submits trastuzumab biosimilar to EMA Biosimilars/News | Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Study of top-down infliximab use in children with Crohn’s disease Biosimilars/Research | Posted 24/03/2017

The Erasmus Medical Center, in collaboration with the Netherlands Organisation for Health Research and Development and biosimilars maker Hospira, now Pfizer, is carrying out a study to investigate...

Potency of generics of piperacillin/tazobactam Generics/Research | Posted 24/03/2017

In an era of increasing bacterial resistance, the potency of antibiotics is critical. Researchers from the Tata Medical Centre, Kolkata, India tested the relative potency of different generic brand...

Evidence on biosimilar efficacy and safety leads to ASAS/EULAR recommendation Biosimilars/Research | Posted 24/03/2017

A study of biological disease-modifying anti-rheumatic drugs (DMARDs) in patients with axial spondyloarthritis (axSpA) found no reason for physicians not to prescribe infliximab biosimilars [1].

Australians pay too much for prescription drugs Pharma News | Posted 24/03/2017

Australians are paying way too much for their prescription drugs, according to a new report released in March 2017 by the Grattan Institute, an independent, non-partisan think tank.

EMA and FDA to recognize GMP inspections Policies & Legislation | Posted 24/03/2017

European Union (EU) and US regulators have agreed to recognize inspections of drugmakers in Europe and the US.

US pharmacy benefit firm suggests rebates are not driving drug price rises Reports | Posted 24/03/2017

Drug pricing has become a prominent political issue in recent years, and especially in the US. High prices for new drugs and continuous increases for older branded drugs (and even generic drugs) ha...