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FDA issues first warning letter for unpaid generics user fees Policies & Legislation | Posted 18/10/2013

In what appears to be the first of its kind, FDA has warned CPM Contract Pharma (CPM) for failing to self identify and pay its generic drug user fees.

US court paves way for Nexium competition Generics/News | Posted 18/10/2013

AstraZeneca announced on 2 October 2013 that the US Court of Appeals for the Federal Circuit had lifted a temporary injunction against the US launch of Hanmi Pharmaceutical’s (Hanmi’s) esomeprazole...

Gastroenterologists unlikely to use infliximab biosimilar Reports | Posted 18/10/2013

Gastroenterologists are unlikely to prescribe an infliximab biosimilar in their Crohn’s disease or ulcerative colitis patients if it has not been clinically tested in inflammatory bowel diseases, a...

Forest initiates lawsuits over generic Savella Generics/News | Posted 18/10/2013

Forest Laboratories and Forest Laboratories Holdings (Forest) announced that Forest and Royalty Pharma Collection Trust (Royalty Pharma) are suing several generics manufacturers regarding generics...

Establishing mAb biosimilarity before reaching the clinic Biosimilars/Research | Posted 11/10/2013

Confirming the biosimilarity of monoclonal antibodies (mAbs) is fraught with challenges beyond those faced by currently approved biosimilars, warn Ebbers and co-authors at Utrecht University, The N...

EU guidelines for nanosimilars Guidelines | Posted 11/10/2013

Last update:  5 November 2013 The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific...

Increased use of generics could save South Africa millions Reports | Posted 11/10/2013

Increasing the use of generics by 5% could save the healthcare industry and patients in South Africa in excess of Rand 400 million per year, according to a report from the country’s pharmaceutical...

US state legislation on biosimilars substitution Policies & Legislation | Posted 11/10/2013

Despite the fact that the US Food and Drug Administration (FDA) has yet to receive a biosimilars application, many US states have been considering legislation on biosimilars substitution [1].