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Copaxone stay rejected and balugrastim withdrawn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for a stay of an appeals court ruling on its blockbuster drug Copaxone (glatiramer acetate) rejected, and that it had withdrawn its application for approval of balugrastim (granulocyte colony-stimulating factor [G-CSF]).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