Biosimilars

Phase III QoL assessments show comparability of biosimilar infliximab

Biosimilars/Research | Posted 10/01/2014

The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Bioanalytical challenges in the development of biosimilars

Biosimilars/Research | Posted 10/01/2014

Some of the topics presented at an international conference on biowaivers and biosimilars, held in the US in September 2012, were applicable to large-molecule bioanalytical methods. These included assay format, glycosylation and immunogenicity, and how differences in these components can impact the evaluation of biosimilars and their subsequent approval.

Teva launches new biologicals in Europe and US

Biosimilars/News | Posted 13/12/2013

Teva Pharmaceutical Industries (Teva) announced on 18 November 2013 the first EU launch for its new long-acting filgrastim molecule Lonquex (lipegfilgrastim) in Germany and the launch of its short-acting granulocyte colony-stimulating factor (G‑CSF) Granix (tbo-filgrastim) in the US.

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).

Germany wants to increase biosimilars penetration

Biosimilars/General | Posted 13/12/2013

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).

Avesthagen and Elpen make deal for biosimilar darbepoetin alfa

Biosimilars/News | Posted 13/12/2013

Indian life science company Avesthagen Pharma (Avesthagen) announced on 19 November 2013 that it had entered into a biosimilars agreement with Greece-based Elpen Pharmaceutical (Elpen).

Norwegian study hopes to increase biosimilars uptake in Europe

Biosimilars/General | Posted 06/12/2013

Despite the fact that many countries within Europe are tightening its health budget, the uptake of lower-cost biosimilars is still relatively low in Europe.

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).

Copaxone stay rejected and balugrastim withdrawn

Biosimilars/General | Posted 06/12/2013

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]).

Non-clinical study shows similarity of biosimilar etanercept

Biosimilars/Research | Posted 29/11/2013

The results of a non-clinical study of a candidate biosimilar etanercept (GP2015) has shown the similarity, with respect to in vitro and in vivo characteristics, of the biosimilar (GP2015) and its reference product, Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept).