Biosimilars
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].
Use of similar biotherapeutic products to treat rheumatoid arthritis in Latin America
Latin America has a significantly lower gross domestic product (GDP) compared to Canada, Europe and the US. Despite this fact, the cost of biologicals is in general very similar to countries with higher GDP, causing problems for patients to gain access to these medications. This problem could possibly be solved by the introduction of lower-cost biosimilars to the region.
Stada in-licenses biosimilar filgrastim
German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.
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.
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.
Clinical trials for follow-on biological products in Brazil
Unlike for generic drugs, authorizing biosimilars without conducting quality clinical trials represents a real threat to patients, according to Professor Valderílio Feijó Azevedo, Professor of Rheumatology at the Universidade Federal do Paraná in Brazil [1].
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.
Biocad and Epirus to invest in follow-on biological products in Brazil
Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.
Analysis of carbohydrate containing biosimilars
During a presentation given by Dr Azadi Parastoo, University of Georgia, GA, USA, at the international conference on biowaivers and biosimilars, held in the US in September 2012, the types of analytical techniques that can be utilized in order to characterize differences in glycosylation for analysis of biosimilars were discussed [1].
WHO naming of biosimilars
The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups [1], but criticized by others.