Biosimilars/General

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Call for clarity in FDA’s draft guidance on biosimilar meetings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

Biologicals sales have almost doubled since 2006

Biosimilars/General | Posted 07/06/2013

Sales of biologicals have almost doubled from US$63.8 billion in 2006 to US$124.6 billion in 2012.

Biosimilars and US exclusivity

Biosimilars/General | Posted 24/05/2013

Currently, the legal pathway in the US for the approval of biosimilars is the Biologics Price Competition and Innovation Act (BPCI Act) of 2009.

Biosimilars applications under review by EMA – 2013 Q1

Biosimilars/General | Posted 12/04/2013

Last update: 12 April 2013

Recall of anaemia drug highlights safety issues of NBCDs

Biosimilars/General | Posted 05/04/2013

US-based biotech firm Affymax announced on 24 February 2013 that it is recalling all lots of its red blood cell-stimulating medicine Omontys (peginesatide). This could have broader implications on how FDA evaluates follow-on non-biological complex drugs (NBCDs).

Pharma companies sue EMA to block release of data

Biosimilars/General | Posted 15/03/2013

US-based biotech companies AbbVie and InterMune have both sued EMA in a bid to block publication of clinical trial data for their drugs.

US FDA defends biosimilar substitution

Biosimilars/General | Posted 01/03/2013

US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, on 20–22 February 2013.

Biosimilars to replace 70% of chemical drugs

Biosimilars/General | Posted 15/02/2013

Biosimilars will replace some 70% of global chemical drugs over the next couple of decades, according to industry experts. This replacement will occur due to the better safety profiles of biosimilars compared to chemical drugs and the fact that many originator biologicals will lose their patent protection in the coming years, according to Mr Appaji, Director General of Pharmaceuticals Export Promotion Council of India (Pharmexcil).

Top developments in biosimilars during 2012

Biosimilars/General | Posted 01/02/2013

Much has happened in the biosimilars’ industry over the last year.

Originator biologicals approved and marketed in Germany

Biosimilars/General | Posted 14/12/2012

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.