News
Biosimilars approved in Japan
2014-10-02 In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW). The Pharmaceuticals and Medical… Read More »
European trade organizations worried about pharmacovigilance fees
2014-09-30 Some of Europe’s major trade associations have expressed their concerns over fees being proposed by the European Medicines Agency (EMA) as part of new European… Read More »
Biosimilar epoetin-κ equivalent to epoetin-β
2014-09-26 In 1989, the first recombinant erythropoietin (rEPO) preparation, epoetin-α, was approved by the US Food and Drug Administration for the treatment of anaemia associated with… Read More »
Use of generic cardiovascular drugs in China
2014-09-24 China has not yet recognized the importance of increasing generics use as a method to reduce drug prices. An analysis of drug prices in hospitals… Read More »
Biosimilars approved in Australia
2014-09-22 In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989. The regulatory body for therapeutic goods in Australia is… Read More »
FDA and Health Canada streamline drug submissions
2014-09-18 The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able… Read More »
FDA starts widespread testing of generics
2014-09-16 The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no… Read More »
Compliance and persistence same for generic and brand-name alendronate
2014-09-12 A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].… Read More »
Inflammatory arthritis: auditioning for the role of biosimilar
2014-09-10 Targeted biological therapies have proven themselves highly effective in the treatment of inflammatory joint diseases, but their benefits are restricted by cost. Biosimilars of these… Read More »
EU majority says same INNs for biosimilars
2014-09-08 According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that… Read More »
