Biosimilars/General
Survey highlights the importance of unique names for biosimilars
A report released by the Alliance for Safe Biologic Medicines (ASBM) on 22 November 2013 highlights the importance of using unique names for identifying biosimilars.
Biosimilars naming debate intensifies
In October 2013, a letter was sent to the US Food and Drug Administration (FDA) by a bipartisan group of US senators calling for biosimilars to have the same active ingredient name as the brand-name originator product [1]. This has prompted a response from ‘authors and champions’ of the biosimilars legislation.
Similar biotherapeutic products under development in Latin America
Last update: 15 November 2013
Similar biotherapeutic products are high on the health policy agenda in Latin America, due to the fact that they are less costly and therefore have the potential to increase access to life-saving drugs. Within individual Latin American countries, the regulatory processes and stages of implementation of similar biotherapeutic products regulation vary widely. Despite this, Latin America is moving towards increasing standards of regulation for these products [1, 2].
EGA commends EMA workshop on biosimilars guidelines
The European Generic medicines Association (EGA) has congratulated the European Medicines Agency (EMA) on its organization of the EMA workshop on biosimilars and urges rapid adoption of its revisions to the agency’s overarching guidelines on biosimilars.
FDA extends biosimilars deadlines due to US shutdown
As a result of the US government shutdown, the US Food and Drug Administration (FDA) has extended the deadlines and goal dates for its biosimilars activities.
ASBM publishes paper on biosimilar naming
The US-based Alliance for Safe Biologic Medicines (ASBM) announced on 28 November 2012 that its recommendations with respect to identification and substitution of biosimilars have been published in the Food and Drug Law Institute (FDLI) policy forum.
EGA’s vision for biosimilars and generics
On 8 October 2013, the European Generic medicines Association (EGA) launched its industrial policy vision for the future of the biosimilars and generics industries in Europe at the EGA Industrial Policy Conference.
Biosimilars applications under review by EMA – 2013 Q2
Last update: 15 October 2013
The 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. 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.
Biosimilars applications under review by EMA – 2013 Q3
Last update: 4 October 2013
The 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. 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.
Fight continues over biosimilar naming standards
Biosimilar products marketed in the US should share the same common non-proprietary name as the reference brand-name biological medicine, according to the Generic Pharmaceutical Association (GPhA).
