Biosimilars
Phase III results of adalimumab biosimilar demonstrate equivalence
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
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
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
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
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
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].
Phase I results for candidate adalimumab, etanercept and infliximab biosimilars
Results of phase I clinical studies of candidate adalimumab biosimilar SB5, etanercept biosimilar SB4 and infliximab biosimilar SB2, demonstrated equivalence safety profiles to their originator biologicals in healthy subjects [1-3].
Non-originator infliximab approved in Russia
South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.
Biosimilars approved in the US
Last update: 23 July 2024
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Biosimilars in the US: hurdles to cost savings
In light of the recent approval of the first biosimilar in the US, Zarxio (filgrastim-sndz), [1], Sarpatwari and co-authors look at the hurdles to cost savings for biosimilars in the US [2].
