Biosimilars/Research

Phase I study shows equivalence of biosimilar rituximab and MabThera

Biosimilars/Research | Posted 13/12/2013

The results of a randomized, controlled, multicentre, two-arm, parallel-group, double-blind study of CT-P10 (rituximab) in patients with rheumatoid arthritis has shown the equivalence, with respect to pharmacokinetics, efficacy and safety, of the biosimilar (CT-P10) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Non-clinical and phase I clinical assessments show similarity of biosimilar rituximab

Biosimilars/Research | Posted 06/12/2013

The results of non-clinical and phase I clinical assessments of a candidate biosimilar rituximab (PF-05280586) have shown similarity, with respect to in vivo, functional characteristics and pharmacokinetic and pharmacodynamic properties, of the biosimilar (PF-05280586) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Open-label studies show similarity of biosimilar infliximab and Remicade

Biosimilars/Research | Posted 22/11/2013

The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the similarity, with respect to efficacy and safety, of the biosimilar infliximab and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Etanercept biosimilar has comparable pharmacokinetics to Enbrel

Biosimilars/Research | Posted 15/11/2013

An etanercept biosimilar (CHS-0214) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

Use of similar biotherapeutic products to treat rheumatoid arthritis in Latin America

Biosimilars/Research | Posted 08/11/2013

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.

Clinical trials for follow-on biological products in Brazil

Biosimilars/Research | Posted 31/10/2013

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].

Extrapolation of biosimilar infliximab indications to inflammatory bowel disease

Biosimilars/Research | Posted 25/10/2013

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.

The future of nanomedicines – nanosimilars

Biosimilars/Research | Posted 18/10/2013

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.

Regulation of similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/08/2013

Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].

Positive phase III data for Epirus infliximab biosimilar

Biosimilars/Research | Posted 06/09/2013

US-based Epirus Biopharmaceuticals (Epirus) announced on 28 August 2013 that its biosimilar infliximab candidate had demonstrated ‘clinical comparability’ to Remicade as measured by the ACR20 response in severe rheumatoid arthritis patients.