News
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EMA releases guidelines on biosimilar interferon beta and r-FSH
2013-06-21 In March 2013, EMA released two guidelines on how pharmaceutical companies should test biosimilar medicines containing interferon beta and recombinant follicle stimulation hormone (r-FSH). Interferon… Read More »
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Japan approves second biosimilar G-CSF
2013-06-19 Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF). The biosimilar G-CSF, filgrastim NK, is produced by Nippon Kayaku and development… Read More »
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Drugmakers accused of stopping shipments to Greece
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… Read More »
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UN urges WTO to keep cheap drug deal for poor countries
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… Read More »
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Patients’ knowledge and perceptions about generics in Australia
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… Read More »
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Egypt issues draft guidelines for biosimilars
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… Read More »
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MS patient dies from immunogenicity to biological drug
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… Read More »
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India supplies 20% of generic drugs worldwide
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.… Read More »
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US FDA defends biosimilar substitution
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,… Read More »
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Prospects for producing follow-on biological products in Brazil
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… Read More »