News
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FDA debuts purple book for biologicals and interchangeable biosimilars
2015-05-14 On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set… Read More »
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Regulating the safety of biosimilars
2015-05-12 Clinical safety is critically important during the development of a biosimilar. An overview of the main aspects of safety assessment of biosimilars has been prepared… Read More »
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Adalimumab biosimilar has comparable pharmacokinetics to Humira
2015-05-08 An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study. Coherus announced on 14 August… Read More »
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Appropriate generics pricing improves medicines availability in Sri Lanka
2015-05-06 The wide availability of generics across Sri Lanka, in both private and semi-government community pharmacies, is increasing the availability and affordability of essential medicines for… Read More »
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Physicians believe biosimilars should have different names
2015-05-04 In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion. On 14 August 2014, more than… Read More »
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Value of generics overlooked in one country that needs them most: Greece
2015-04-30 A study of physicians’ prescribing patterns and perceptions towards generics in Greece has revealed a clear need for an appropriate regulatory framework and organized generic… Read More »
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ECCO survey highlights lack of confidence in biosimilar mAbs
2015-04-28 In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on… Read More »
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Trends in the financial burden of diabetes treatment
2015-04-23 The number of adults diagnosed with diabetes in the US increased 75% between 2000 and 2010, resulting in 9% of the adult population with diabetes.… Read More »
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Biosimilars in the treatment of chemotherapy-induced anaemia
2015-04-21 A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology and oncology has shown the biosimilars… Read More »
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Right of appeal provision in CETA
2015-04-17 The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada has the potential to have a negative affect on the generics… Read More »