News

Drugmakers accused of stopping shipments to Greece

Published on 2013/06/17

Greece is facing a severe drug shortage in more than 200 drugs. The worrying situation is being blamed on drugmakers that have stopped shipping their products to the country due to debts or fear of pa...

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UN urges WTO to keep cheap drug deal for poor countries

Published on 2013/06/14

Two United Nations (UNs) agencies are urging the extension of an exemption for least-developed countries on patent protection to ensure that HIV/AIDS and other lifesaving drugs remain affordable for t...

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Patients’ knowledge and perceptions about generics in Australia

Published on 2013/06/12

Most Australians know about generics but are not sure if they prefer brand-name or generic drugs, according to a survey carried out by Australian researchers and published in December 2012 in the Jou...

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Egypt issues draft guidelines for biosimilars

Published on 2013/06/10

The Egyptian Drug Authority (EDA) announced on 20 January 2013 that a draft guideline for the registration of biosimilars in Egypt had been released by the Central Administration for Pharmaceutical Af...

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MS patient dies from immunogenicity to biological drug

Published on 2013/06/07

A Swedish woman diagnosed with multiple sclerosis (MS) appears to have died after developing unwanted immunogenicity toward the biological drug Tysabri (natalizumab), according to a report in the jour...

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India supplies 20% of generic drugs worldwide

Published on 2013/06/05

Every fifth tablet, capsule and injectable generic drug being used in the world is manufactured in India, according to India’s Health Minister Ghulam Nabi Azad. Minister Azad told the Lok Sabha (In...

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US FDA defends biosimilar substitution

Published on 2013/06/03

US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, o...

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Prospects for producing follow-on biological products in Brazil

Published on 2013/05/31

New research shows the need for local production of biologicals in Brazil in order to offset the increasing medicines budget and reduce the trade deficit when it comes to drugs. In 2010, the Brazil...

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Merck makes biosimilars deal with Samsung Bioepis

Published on 2013/05/29

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis. Samsung Bioepis is a joint venture between South Korean electro...

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The ethics of biosimilars

Published on 2013/05/27

Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical leve...

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Amgen’s response to biosimilar substitution legislation in US

Published on 2013/05/24

Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrain t...

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Assessment of interchangeability under the BPCI Act

Published on 2013/05/22

The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substit...

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