Biosimilars
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.
Extrapolation of biosimilar infliximab indications to inflammatory bowel disease
Gastroenterologists are wary of using biosimilars of infliximab in the treatment of inflammatory bowel disease. This fact is being evidenced by the publication of position statements from various professional groups.
Similar biotherapeutic products approved and marketed in Latin America
Last update: 29 November 2019
Regulation of similar biotherapeutic products in Latin America varies widely among different countries. Although many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].
EGA’s vision for biosimilars and generics
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.
The future of nanomedicines – nanosimilars
First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines.
Establishing mAb biosimilarity before reaching the clinic
Confirming the biosimilarity of monoclonal antibodies (mAbs) is fraught with challenges beyond those faced by currently approved biosimilars, warn Ebbers and co-authors at Utrecht University, The Netherlands [1]. The threat of unexpected immunogenicity has been well reported, but the problems do not start there. The first steps towards establishing the biosimilarity of an anticancer mAb, the preclinical stage, presents challenges of its own.
