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US generics manufacturers renew calls for labelling revisions Policies & Legislation | Posted 22/05/2015

The Generic Pharmaceutical Association (GPhA) has stepped up pressure on the US Food and Drug Administration (FDA) to update its proposed generics labelling requirements. According to GPhA, FDA sho...

Generics of high blood pressure medication launched Generics/News | Posted 22/05/2015

On 31 March 2015, generics majors Mylan, Sandoz and Teva Pharmaceutical Industries (Teva) announced the US launch of their respective generic amlodipine and valsartan combination tablets in four do...

Clinical trials for adalimumab biosimilars Biosimilars/Research | Posted 15/05/2015

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical tri...

Patients’ and physicians’ perceptions of HIV generics Generics/Research | Posted 15/05/2015

A study of adult HIV positive outpatients and their physicians in clinics across France found that a third of patients and a quarter of physicians are openly opposed to antiretroviral generics [1].

Iran approves its first rituximab biogeneric Biosimilars/News | Posted 15/05/2015

In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on...

Australia to adopt EMA’s biosimilars guidelines Guidelines | Posted 15/05/2015

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European U...

Alternative proposal for generics labelling Policies & Legislation | Posted 15/05/2015

Consumer and patient advocacy groups clashed with economists and generics makers at the US Food and Drug Administration’s (FDA) public hearing over the agency’s proposed rule to allow generics make...

TWi and Takeda settle dispute over anti-reflux generic Generics/News | Posted 15/05/2015

Taiwan-based TWi Pharmaceuticals (TWi) announced on 27 April 2015 that it had entered into a settlement agreement with Takeda Pharmaceutical Company, Takeda Pharmaceuticals USA and Takeda Pharmaceu...