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California governor vetoes biosimilars bill Policies & Legislation | Posted 18/10/2013

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598, a bill that some believed would have impeded access to biosimilars.

US state introduces law to allow meds to be bought over Internet Pharma News | Posted 18/10/2013

On 9 October 2013, the US state of Maine introduced a law allowing its residents to purchase foreign prescription drugs over the Internet.

EMA issues draft reflection paper for iron-based nano-colloidal products Guidelines | Posted 18/10/2013

On 7 October 2013, the European Medicines Agency (EMA) announced the publication of a draft reflection paper‡ to discuss the data requirements for intravenous iron-based nano-colloidal products dev...

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...