Biosimilars

FDA accepts application for etanercept biosimilar

Biosimilars/News | Posted 09/10/2015

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).

Another infliximab switching trial started

Biosimilars/News | Posted 02/10/2015

In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.

Biosimilar epoetin-α as effective as originator in anaemia treatment

Biosimilars/Research | Posted 02/10/2015

A study by researchers in Italy has concluded that biosimilar epoetin‑α appears to be comparable to originator epoetin‑α plus liposomal iron (Sideral), vitamin B12 and folates in terms of efficacy and safety for the treatment of refractory anaemia [1].

Biosimilar etanercept safe and effective

Biosimilars/Research | Posted 02/10/2015

In a study funded by Samsung Bioepis (a Biogen and Samsung joint venture), their candidate etanercept biosimilar (SB4) has been found to be safe and well tolerated and to be equivalent in terms of efficacy compared to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) [1].

Positive phase III results for bevacizumab biosimilar

Biosimilars/Research | Posted 25/09/2015

Results of a phase III trial have demonstrated the similarity of partners Amgen and Allergan’s biosimilar bevacizumab candidate (ABP 215) to Avastin in patients with advanced non-small cell lung cancer (NSCLC).

Biosimilar production in Malaysia

Biosimilars/News | Posted 25/09/2015

Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.

Dutch medicines agency aims to clarify biosimilars confusion

Biosimilars/General | Posted 25/09/2015

The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.

Biosimilar insulin launched in the UK

Biosimilars/News | Posted 18/09/2015

Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.

Pharmacoeconomic modelling of biosimilars in the US

Biosimilars/Research | Posted 18/09/2015

There are many challenges and uncertainties associated with the introduction of biosimilars to the US. To try and address these, authors from the Partnership for Health Analytic Research developed a conceptual framework to provide guidance in modelling biosimilars in the US setting [1].

Biosimilars applications under review by EMA – August 2015

Biosimilars/General | Posted 18/09/2015

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

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].