News

The future of nanomedicines – nanosimilars

Published on 2013/11/12

First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines. Nanomedicine is ...

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California governor vetoes biosimilars bill

Published on 2013/11/08

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. The Generic Pharmaceutical Association (GPh...

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Regulation of similar biotherapeutic products in Latin America

Published on 2013/11/06

Regulation of similar biotherapeutic products (SBP) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is ...

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Generics may be allowed to change drug labelling

Published on 2013/11/04

FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers. Under current regulations generics manufacturers cannot update t...

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Use of brand-name drugs increasing healthcare costs in US

Published on 2013/11/01

Patients with diabetes who are covered by the US healthcare insurance Medicare are two to three times more likely to use expensive brand-name drugs compared to patients treated within the Veterans Aff...

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Biosimilar competition in Europe

Published on 2013/10/30

A study of five European Union (EU) countries has revealed that Germany provides the most favourable environment for uptake of biosimilars. The study, which was led by Professor Henry Grabowski, Di...

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Patient care threatened by cancer drug shortages

Published on 2013/10/28

Drug shortages are affecting most US oncologists, impacting on life-saving patient care, according to the findings of the largest study yet to quantify the impact of cancer drug shortages. Of 250 boar...

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Generics combo non-inferior to treatment with Enbrel

Published on 2013/10/25

A study carried out by researchers from the US Department of Veterans Affairs and the Canadian Institutes for Health Research has found that a combination of three generic drugs is non-inferior to tre...

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EMA approves first monoclonal antibody biosimilars

Published on 2013/10/23

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorizations for the first t...

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Ranbaxy faces lawsuit in India

Published on 2013/10/21

An Indian lawyer has filed a lawsuit asking the Indian Supreme Court to investigate Ranbaxy Laboratories (Ranbaxy), its executives and Indian drug control officers, as well as to shut down two of Ranb...

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Erythropoietin biosimilars in bone marrow transplantation and stem cell donation

Published on 2013/10/18

Combination therapy with granulocyte colony-stimulating factor (G-CSF) and erythropoietin (EPO) has been used with the aim of accelerating the recovery of red blood cells following autologous bone mar...

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Infliximab biosimilar comparable to Remicade

Published on 2013/10/16

South Korean biotechnology company Celltrion presented results of its extended trials for its biosimilar infliximab candidate Remsima (CT-P13) at the European League Against Rheumatism (EULAR) 2013 Co...

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