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Naming requirements in Australian biosimilars guidance Guidelines | Posted 04/10/2013

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on...

Transplant coordinators’ perception of generic immunosuppressants Generics/Research | Posted 04/10/2013

Transplant coordinators associate the availability of multiple generic immunosuppression therapies with increased patient confusion, according to a study by Parker and co-authors [1].

Biosimilars applications under review by EMA – 2013 Q3 Biosimilars/General | Posted 04/10/2013

Last update: 4 October 2013The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003...

Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins Policies & Legislation | Posted 04/10/2013

Canada’s federal department responsible for health, Health Canada, is asking drugmakers seeking approval of similar drugs containing low molecular weight heparins (LMWHs) to use the approval pathwa...

Generics applications under review by EMA – 2013 Q3 Generics/General | Posted 04/10/2013

Last update: 4 October 2013 Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EM...

Johnson & Johnson warns of shortages of cancer drug Doxil Pharma News | Posted 04/10/2013

Janssen Pharmaceutical Companies (Janssen), a division of healthcare giant Johnson & Johnson, has warned of impending shortages of its ovarian cancer drug Doxil (doxorubicin).

Generics of fish oil cholesterol treatment get go ahead Generics/News | Posted 04/10/2013

A US appeals court ruled on 12 September 2013 that generics companies can develop their own versions of Lovaza, a fish oil-derived drug used to treat high cholesterol, which is currently marketed i...

Australian generics association releases new code of practice Generics/General | Posted 04/10/2013

Australia’s Generic Medicines Industry Association (GMiA) announced on 26 September 2013 the release of the draft third edition of the GMiA Code of Practice, which incorporates a number of new amen...