More Articles

Compromise reached on US legislation on biosimilars substitution Policies & Legislation | Posted 16/01/2015

Biologicals companies, including Amgen, Actavis, Sandoz, Hospira and Genentech, and the Generic Pharmaceutical Association (GPhA) have agreed to support compromise automatic substitution legislatio...

Extrapolation of indications in biosimilars: infliximab Biosimilars/Research | Posted 09/01/2015

Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. This in turn may lead them to distrust biosimilars, leading...

FDA advisers recommend approval of filgrastim biosimilar Biosimilars/News | Posted 09/01/2015

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex...

EU problematic patent settlements stabilize Reports | Posted 09/01/2015

The number of patent settlements between originator and generics companies concluded during 2013 has reduced compared to 2012. While the number of problematic or so-called ‘pay-for-delay’ deals hav...

First infliximab ‘similar biologic’ launched in India Biosimilars/News | Posted 09/01/2015

India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be...

GPhA comments on generics’ legislation and Trans-Pacific Partnership Generics/General | Posted 09/01/2015

Mr Ralph G Neas, President and CEO of the US Generic Pharmaceutical Association (GPhA), has commented on proposed legislation for generics in the US, as well as on provisions in the Trans-Pacific P...

Phase I study shows darbepoetin alfa biosimilar to be well tolerated Biosimilars/Research | Posted 09/01/2015

Chong Kun Dang Pharmaceutical (CKD Pharma) announced on 18 November 2014 the successful completion of its phase I pharmacokinetics study for its biosimilar darbepoetin alfa product.

Generics makers to be penalized for huge price hikes Policies & Legislation | Posted 09/01/2015

Legislation was introduced into the US Senate on 20 November 2014 that, if passed, would require generics makers that increase prices dramatically to pay a rebate to Medicaid*.