Biosimilars/General

Similar biotherapeutic products under development in Latin America

Biosimilars/General | Posted 15/11/2013

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

Biosimilars/General | Posted 08/11/2013

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

Biosimilars/General | Posted 31/10/2013

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

Biosimilars/General | Posted 30/11/2012

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

Biosimilars/General | Posted 25/10/2013

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

Biosimilars/General | Posted 05/07/2013

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

Biosimilars/General | Posted 04/10/2013

Last update: 4 October 2013

Fight continues over biosimilar naming standards

Biosimilars/General | Posted 27/09/2013

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).

Biosimilars applications under review by EMA – 2012 Q4

Biosimilars/General | Posted 11/01/2013

Last update: 23 August 2013

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’.

Call for clarity in FDA’s draft guidance on biosimilar meetings

Biosimilars/General | Posted 14/06/2013

Drug companies have made comments on FDA’s draft guidance for industry on formal meetings between the agency and biosimilars manufacturers. They believe that the guidance needs some revision to protect data and provide clarity.