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Physicians believe biosimilars should have different names Biosimilars/General | Posted 29/08/2014

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

FDA receives application for monoclonal antibody biosimilar Biosimilars/News | Posted 29/08/2014

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed the filing procedure to obtain US Food and Drug Administration (FDA) appro...

Branded drugmaker could be sued for generic’s side effects Pharma News | Posted 29/08/2014

The Alabama Supreme Court has ruled, for the second time, that Pfizer could be sued for damages allegedly caused by its heartburn drug Reglan (metoclopramide), even if the plaintiff had only taken...

Idaho proposes legislation on biosimilars substitution Policies & Legislation | Posted 29/08/2014

The Idaho Board of Pharmacy held a hearing on 5 and 6 August 2014 regarding proposed regulations for the treatment of biosimilars in their state.

Lawyers look at new price hike for old drug Generics/General | Posted 29/08/2014

Two generic drug companies are being investigated by the Connecticut Attorney General’s office following reports of alarming price hikes for the heart medicine digoxin. Possible price fixing by Imp...

US court puts generic Gralise on hold Generics/News | Posted 29/08/2014

US specialty drugmaker Depomed has received a favourable preliminary verdict in its case against generics manufacturer Actavis, which had applied to market a generic version of Depomed’s treatment...

FDA releases draft guidance on reference product exclusivity for biologicals Guidelines | Posted 22/08/2014

The US Food and Drug Administration (FDA) has issued new draft guidance concerning biosimilars. The draft guidance, issued on 5 August 2014, is intended to assist sponsors in determining the date o...

Trends in the financial burden of diabetes treatment Generics/Research | Posted 22/08/2014

The number of adults diagnosed with diabetes in the US increased 75% between 2000 and 2010, resulting in 9% of the adult population with diabetes. The cost of health care for people with diabetes i...