Biosimilars

Rituximab biosimilar Truxima approved in Canada

Biosimilars/News | Posted 19/04/2019

Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries, announced on 10 April 2019 that Health Canada had approved its rituximab biosimilar Truxima. This marks the first rituximab biosimilar to be approved by the Canadian medicines’ regulator.

Eli Lilly to introduce half-price authorized insulin biosimilar in US

Biosimilars/General | Posted 19/04/2019

With high drug prices increasingly coming into the spotlight, Eli Lilly has announced that it will introduce a lower-priced authorized biosimilar version of its diabetes treatment Humalog (insulin lispro) in the US.

Economic considerations for biosimilars in the US

Biosimilars/Research | Posted 19/04/2019

Smeeding and colleagues explore cost considerations related to biosimilars in the US, and present a broad perspective on value beyond price reduction in a recent review.

EC approval for adalimumab biosimilar Idacio

Biosimilars/News | Posted 12/04/2019

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

Efficacy and safety of bevacizumab biosimilar ABP 215

Biosimilars/Research | Posted 12/04/2019

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Key considerations for biosimilars in the US

Biosimilars/Research | Posted 12/04/2019

Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake.

Biocad advancing its non-originator biologicals in Russia

Biosimilars/General | Posted 12/04/2019

Russian biotechnology company Biocad has started an eculizumab study and has also registered its non-originator biological (BCD 057) in Russia.

ESMO survey highlights need for education and alignment

Biosimilars/Research | Posted 05/04/2019

The results of a survey carried out by the European Society for Medical Oncology (ESMO) on biosimilars understanding in oncologists have highlighted the need for education and worldwide alignment [1].

Sandoz resubmits pegfilgrastim biosimilar to FDA

Biosimilars/News | Posted 05/04/2019

Sandoz, the generics division of Novartis, announced on 3 April 2019 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the US Food and Drug Administration (FDA).

Phase III clinical trials started for adalimumab biosimilars

Biosimilars/Research | Posted 05/04/2019

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.