Biosimilars

Comments on FDA’s guidance on naming biologicals

Biosimilars/General | Posted 11/09/2015

The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by the agency.

Biosimilar etanercept approved in South Korea

Biosimilars/News | Posted 11/09/2015

US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug Safety (MFDS) in Korea.

Etanar as effective as adalimumab and infliximab in rheumatoid arthritis

Biosimilars/Research | Posted 11/09/2015

A study of Etanar – an etanercept similar biotherapeutic product – has shown that it is as effective as adalimumab and infliximab in a cohort of patients with rheumatoid arthritis in a real-life setting [1].

Zarxio first biosimilar to be launched in US

Biosimilars/News | Posted 04/09/2015

The US has entered a new era in medicines with the historic launch of the country’s first biosimilar. Sandoz, the generics division of Novartis, announced on 3 September 2015 that it had launched its filgrastim biosimilar, Zarxio (filgrastim-sndz), in the US.

Phase III results of adalimumab biosimilar demonstrate equivalence

Biosimilars/Research | Posted 04/09/2015

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 6 July 2015 phase III data demonstrating the ‘clinical equivalence’ of their adalimumab biosimilar (SB5) compared to the originator biological, Humira.

Non-originator bevacizumab candidate non-inferior to Avastin

Biosimilars/Research | Posted 28/08/2015

Results of a phase III clinical study of Biocad’s non-originator bevacizumab candidate BCD-021 demonstrated ‘equivalence’ compared to the originator biological (Avastin) in patients with non-small cell lung cancer (NSCLC) [1].

Rituximab similar biologic launched in India

Biosimilars/News | Posted 28/08/2015

India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.

Australian approval for infliximab biosimilar

Biosimilars/General | Posted 21/08/2015

South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the infliximab biosimilar Inflectra.

Positive phase III results for candidate etanercept and infliximab biosimilars

Biosimilars/Research | Posted 21/08/2015

Results of pivotal phase III clinical studies of candidate etanercept biosimilar SB4 and candidate infliximab biosimilar SB2 met their primary endpoints, demonstrating equivalence to the originator biological in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy [1, 2].

Overcoming hurdles to biosimilars cost savings in the US

Biosimilars/Research | Posted 14/08/2015

The US approved its first biosimilar, Zarxio (filgrastim-sndz), on 6 March 2015 [1]. But how can the country overcome hurdles to the cost savings that can be achieved from these drugs? That is a question Sarpatwari and co-authors have tried to answer [2].