Biosimilars/General
Originator biologicals approved and marketed in Germany
Last updated: 14 December 2012
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biologicals, in Germany.
Competing biosimilars to Amgen’s biologicals
Amgen has been a leading biotechnology company since 1980. Amgen pioneered the development of novel products based on advances in recombinant DNA and molecular biology and launched the biotechnology industry’s first blockbuster medicines.
ABPI issues position paper on biosimilars
The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, announced on 12 November 2012 the publication of its position paper on biosimilars.
Biosimilars approved and marketed in Germany
Last updated: 23 November 2012
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing authorization, of medicinal products, including biosimilars, in Germany.
American dermatologists update position statement on biosimilar substitution
On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and naming of biosimilars.
EMA definitions of generics and biosimilars
Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem. The members of the Biosimilar Medicinal Products Working Party at EMA have recently expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term in the scientific literature and elsewhere [1].
Biosimilars applications under review by EMA
Last update: 11 January 2013
EMA is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or ‘reference drug’.
Teva asks FDA to delay approval of Biogen’s MS drug
Teva Pharmaceutical Industries (Teva) has petitioned FDA not to approve Biogen Idec’s (Biogen’s) investigational pill for treatment of multiple sclerosis, BG-12 (dimethyl fumarate), citing safety concerns.
EMA publishes revised biosimilar Q&A document for patients
On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.
Naming and interchangeability of biosimilars raised in new survey
The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.
