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Biosimilars developments during 2013

Last update: 12 February 2014 

The past year has been a busy one for the biosimilars’ industry. One of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar infliximab [Remsima/Inflectra] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4]. In fact, in Europe, the European Medicines Agency (EMA) has been busy during 2013 approving five biosimilars [5, 6].

Biosimilars applications under review by EMA – 2013 Q4

Last update: 17 January 2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (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.

J&J adds its opinion to biosimilars naming debate

In the ongoing saga over how to name biosimilars healthcare giant Johnson & Johnson (J&J) has added its opinion to the melting pot; petitioning the US Food and Drug Administration (FDA) to give biosimilars similar, but not identical names, to those of the originator biological products.

Calls for biosimilars to have same INN at WHO meeting

Last update: 7 February 2014 

The World Health Organization (WHO) held its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances on 22 October 2013 in Geneva, Switzerland. During the meeting some stakeholders called for biosimilars to be assigned the same INN as their reference biologicals, while others called for the use of distinct non-propriety names.

Biologicals sales quadruple from 2002 to 2017

Biologicals are outstripping regular pharmaceuticals in terms of growth and taking a bigger and bigger chunk of overall drug sales. Increasingly, biosimilars and non-originator biologicals are also taking a small share of this market.

Copaxone stay rejected and balugrastim withdrawn

Teva Pharmaceutical Industries (Teva) had its request for a stay of an appeals court ruling on its blockbuster drug Copaxone (glatiramer acetate) rejected, and that it had withdrawn its application for approval of balugrastim (granulocyte colony-stimulating factor [G-CSF]).

Merck acquires follow-on Copaxone NBCD: determined to lead in MS

Germany-based Merck already markets its own multiple sclerosis (MS) drug Rebif (interferon beta-1a) but suffered a major blow during 2011 when regulators on both sides of the Atlantic rejected its oral MS treatment Movectro (cladribine). Merck has since abandoned the project.

Germany wants to increase biosimilars penetration

Germany may introduce regulations to increase the uptake of biosimilars in the country, according to Mr Mathias Heck, who serves as the European Union Legal and Policy Counsel with the European Office of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI).

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.

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