Biosimilars

Safe for IBD patients to switch to biosimilar infliximab

Biosimilars/Research | Posted 24/02/2017

A UK study has shown that inflammatory bowel disease (IBD) patients can be safely switched from originator infliximab, Johnson & Johnson’s and Merck’s Remicade, to biosimilar infliximab using a managed-switching programme [1].

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar

Biosimilars/News | Posted 24/02/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).

Biocon wins three-year contract to supply insulin in Malaysia

Biosimilars/News | Posted 24/02/2017

Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to the country, a deal reportedly worth US$68 million.

Etanercept biosimilar submitted for approval in Japan

Biosimilars/News | Posted 17/02/2017

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).

Regional management of biosimilars in Germany

Biosimilars/Research | Posted 17/02/2017

Biosimilars offer alternative treatment options and reduce the financial burden on healthcare systems often brought about by more expensive originator drugs. Approved biosimilars of tumour necrosis factor-alpha (TNF-α) inhibitors, such as infliximab or etanercept, are managed differently across Europe. A recent study by Dr Mathias Flume assesses the prescription structure and regional uptake of these biosimilars across Germany, with focus on the Westphalia-Lippe region [1].

Positive results for Pfizer’s adalimumab biosimilar

Biosimilars/Research | Posted 17/02/2017

US pharma giant, Pfizer, reported positive top-line results from a comparative study of their candidate adalimumab biosimilar (PF-06410293). The originator biological, AbbVie’s Humira (adalimumab) had sales of just over US$14 billion in 2015 [1], up 11.7% on the previous year, and retaining its place as the top grossing pharmaceutical product globally.

Biosimilars in 2016: the highlights

Biosimilars/General | Posted 10/02/2017

Previous years have been momentous for the biosimilars industry and 2016 is no exception [1]. Important milestones achieved during 2016 were the biosimilar approvals of Inflectra (infliximab-dyyb), Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto) by the US Food and Drug Administration (FDA).

EMA approval for adalimumab biosimilars Amgevita and Solymbic

Biosimilars/News | Posted 10/02/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.

Positive phase III results for adalimumab biosimilar from Coherus

Biosimilars/Research | Posted 10/02/2017

A phase III study of an adalimumab biosimilar (CHS‑1420) from Coherus has reported that the biosimilar is ‘similar’ to AbbVie’s Humira (adalimumab), according to the company.

Position statement on approval of biosimilars in Latin America

Biosimilars/General | Posted 10/02/2017

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’. Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.