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EMA approval for insulin and rituximab biosimilars Biosimilars/News | Posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sano...

Biosimilar substitution in Europe Reports | Posted 26/05/2017

In the European Union (EU), decisions on the interchangeability or substitution of biosimilars and originator biologicals are not made by the European Medicines Agency (EMA), but at the national le...

Lawmakers urge CMS to reverse its biosimilars policy Policies & Legislation | Posted 26/05/2017

Senator Pat Roberts and Representatives Joe Barton and Anna Eshoo, along with a delegation of 52 House Members and nine Senators, have asked the Centers for Medicare & Medicaid Services (CMS) t...

Generic substitution of antiretroviral drugs in Ireland: patient views Generics/Research | Posted 26/05/2017

Researchers in Ireland report the findings of a survey of opinions on the generic substitution of antiretroviral (ARV) drugs [1], revealing that over 70% of patients would have no concerns about th...

Biosimilars in the treatment of inflammatory bowel disease Biosimilars/Research | Posted 26/05/2017

Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of the gastrointestinal tract: Crohn’s disease and ulcerative colitis. Appr...

Vytorin generic launched in the US Generics/News | Posted 26/05/2017

The US Food and Drug Administration (FDA) has approved a generic version of the anti-cholesterol drug Vytorin, which will be launched on the US market by Impax Laboratories Inc (Impax).

EMA guidance for NBCDs and products approved Biosimilars/Research | Posted 26/05/2017

The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has also published a wide range of other guidance, which outlines the techn...

Generics and biosimilars: status in the EU Generics/General | Posted 26/05/2017

According to Medicines for Europe, without generic medicines Europe would have paid Euros 100 billion more for its medicines in 2014 alone. In a recent interview, the Association’s President Jacek...