Biosimilars/Research

Biosimilar naming conventions around the world

Biosimilars/Research | Posted 20/11/2015

Naming conventions from around the world was one of the topics investigated in a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) [1].

Positive phase III results for Samsung Bioepis biosimilars

Biosimilars/Research | Posted 20/11/2015

Results of phase III clinical studies of candidate etanercept biosimilar SB4 infliximab biosimilar SB2 and adalimumab biosimilar SB5 have all met their primary endpoints, according to an announcement on 7 November 2015 by Samsung Bioepis (a Biogen and Samsung joint venture).

Biosimilars and interchangeability

Biosimilars/Research | Posted 13/11/2015

In a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) the question of interchangeability around the world was one of the topics investigated [1].

Economic considerations for rheumatoid arthritis biosimilars

Biosimilars/Research | Posted 13/11/2015

In the paper by Gulácsi et al. [1], the authors stated that biosimilars have the potential to reduce costs and increase patient access to biologicals in the treatment of rheumatoid arthritis (RA) and other chronic inflammatory rheumatic and bowel diseases.

Non-originator low molecular weight heparins: generics or biosimilars

Biosimilars/Research | Posted 06/11/2015

First developed in the 1980s, low molecular weight heparins (LMWHs) are complex anticoagulants derived from porcine intestinal mucosa and are used in the treatment of deep vein thrombosis and pulmonary embolism. Heparin sodium’s anticoagulant activity is mainly governed by its ability to bind to the serine protease inhibitor antithrombin (AT). In this sense, heparin sodium functions as a cofactor for AT by modifying its conformation, thereby accelerating the inactivation of clotting factors.

Positive phase I results for adalimumab biosimilar

Biosimilars/Research | Posted 06/11/2015

In an announcement on 28 October 2015, biopharmaceutical specialist Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) claimed that results from a phase I study of its adalimumab biosimilar (BI 695501) had ‘demonstrated pharmacokinetic bioequivalence’ to Humira (adalimumab).

Biosimilar naming and AE reporting

Biosimilars/Research | Posted 30/10/2015

How will biosimilar naming affect the ability to attribute adverse events (AEs) to a particular product? This is a question researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1].

Rituximab biosimilar claimed similar pharmacokinetics to originator

Biosimilars/Research | Posted 30/10/2015

A phase I/II study of Pfizer’s rituximab biosimilar candidate PF-05280586 has shown similar pharmacokinetic (PK) properties, according to Jacobs and co-authors [1].

Biosimilars use in Italy increasing

Biosimilars/Research | Posted 23/10/2015

A study of the use of biosimilars in four large Italian geographic areas has found that the use of biosimilar erythropoiesis-stimulating agents (ESAs), especially in naïve patients, increased significantly during the years 2009–2013 [1].

Positive phase I results for pegfilgrastim biosimilar

Biosimilars/Research | Posted 16/10/2015

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 1 October 2015 that results from a phase I study of its pegfilgrastim biosimilar (CHS‑1701) had met its primary endpoint.

Answers to questions about anti-TNF biosimilars

Biosimilars/Research | Posted 09/10/2015

While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the ‘switchability’ and relative immunogenicity of biosimilars and their reference drugs. In a review by Isaacs and co-authors, these questions with reference to CT-P13 (Remsima, Inflectra), a biosimilar of the anti-tumour necrosis factor (TNF) monoclonal antibody infliximab (Remicade) were discussed [1].

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].

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).

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].

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].

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].

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].

Safety of filgrastim biosimilars following stem-cell transplantation

Biosimilars/Research | Posted 07/08/2015

The safety of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars was compared with that of the originator, Neupogen (Amgen), in a retrospective, single-institution study. Simona Bassi and co-authors at the Guglielmo da Saliceto Hospital in Piacenza, Italy, analysed data from patients with lymphoma or myeloma who had undergone autologous haematopoietic stem cell transplantation (HSCT) at the Guglielmo da Saliceto Hospital.

Biosimilars in the US: hurdles to cost savings

Biosimilars/Research | Posted 07/08/2015

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].

Efficacy of filgrastim biosimilars following stem-cell transplantation

Biosimilars/Research | Posted 31/07/2015

The efficacy of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars has been assessed in terms of engraftment following stem-cell transplantation. Time to engraftment was compared following treatment with the originator, Neupogen (Amgen), and with biosimilars in a retrospective, single-institution study.

Approval of biosimilar insulins: regulations across the globe

Biosimilars/Research | Posted 31/07/2015

Insulin analogue patent expiry is likely to mean that biosimilars will be submitted for licensing. In light of this, Heinemann and co-authors reviewed regulatory requirements for biosimilars, notably insulin, in several regions and countries [1].

Norway, biosimilars in different funding systems

Biosimilars/Research | Posted 03/07/2015

Norway has approved biosimilar versions of the biologicals somatropin, epoetin, filgrastim and infliximab. Epoetin and filgrastim are included in a national tender for drugs used in hospitals, in which prices can be reduced by up to 89%. Regional health care is responsible for funding drugs used in hospitals and at home, and it is their responsibility for obtaining the best prices. The H-prescription system in Norway works best to maximize biosimilar competition, as exemplified by the approach taken for infliximab. However, the effect of existing biosimilars on prescriptions has varied [1].

Approval of biosimilars in rheumatology

Biosimilars/Research | Posted 26/06/2015

Biosimilars are approved following a regulatory pathway different to that of generics, as they are not molecularly identical to their reference products. Currently, only one biosimilar is approved by the European Medicines Agency (EMA) for the treatment of rheumatological diseases: an infliximab biosimilar, which is commercialized as Remsima/Inflectra [1]. With this approval in mind, author Gilberto Castañeda-Hernández and co-authors discuss what rheumatologists should know about biosimilars [2].

Real-life results for Inflectra compared to Remicade

Biosimilars/Research | Posted 26/06/2015

Results of a post-marketing clinical study of infliximab biosimilar Inflectra demonstrated equivalent effectiveness compared to the originator biological (Remicade) in patients with rheumatoid arthritis and ankylosing spondylitis when switched from Remicade [1].

Biosimilars in the US

Biosimilars/Research | Posted 19/06/2015

The US Food and Drug Administration (FDA) approved the country’s first biosimilar Zarxio (filgrastim-sndz) on 6 March 2015 [1]. But how will biosimilars be classified in the future and how will savings for biosimilars be realized in the US? These are questions Sarpatwari and co-authors sought to answer [2].

Remsima shows comparable safety and efficacy in IBD patients

Biosimilars/Research | Posted 19/06/2015

South Korean biotechnology company Celltrion presented results of clinical experience for its infliximab biosimilar Remsima (CT-P13) at Digestive Diseases Week (DDW) 2015, which was held in Washington DC, USA, on 17–19 May 2015.

Inflectra shows comparable results in IBD patients

Biosimilars/Research | Posted 12/06/2015

US-based generics maker Hospira presented preliminary results from its Hungarian National Registry study for its infliximab biosimilar Inflectra at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference, which was held in Barcelona, Spain on 18–21 February 2015.

Cost of filgrastim biosimilars compared to originator filgrastim

Biosimilars/Research | Posted 05/06/2015

Italian researchers have completed a retrospective cost analysis comparing the use of filgrastim biosimilars with the originator granulocyte colony-stimulating factor (G-CSF). Their retrospective, single institution study of 56 lymphoma and myeloma patients concluded that treatment with the biosimilars Tevagrastim and Zarzio was associated with cost reductions of 56% and 86%, respectively.

Biosimilars for the treatment of Crohn’s disease

Biosimilars/Research | Posted 12/06/2015

The introduction of targeted biological therapies has improved the treatment of immune inflammatory arthritis and other autoimmune diseases, in particular, Crohn’s disease (CD). The monoclonal antibodies infliximab and adalimumab have shown beneficial effects in patients with CD and high disease activity. The forthcoming introduction of biosimilars is expected to improve access to these expensive medications with an expected reduction in price ranging from 20 to 40 per cent of the present cost.

Clinical trials for etanercept biosimilars

Biosimilars/Research | Posted 22/05/2015

Researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for etanercept biosimilars as part of their investigation into biosimilars for the treatment of psoriasis [1].

Clinical trials for infliximab biosimilars

Biosimilars/Research | Posted 29/05/2015

A systematic review into clinical trials for infliximab biosimilars was carried out as part of an investigation into biosimilars for the treatment of psoriasis by researchers from the Charité – Universitätsmedizin Berlin, Germany [1].

Incomplete processing in recombinant streptokinase

Biosimilars/Research | Posted 29/05/2015

A study investigating the impact of incomplete processing on streptokinase activity has found that ‘similar biologics’ or different batches of the biological may have different potencies, depending on the degree of amino-terminal methionine processing and on the pharmacopoeial assay method used, affecting the dosage patients receive [1].

Variation in recombinant streptokinase

Biosimilars/Research | Posted 22/05/2015

A study of blood clot dissolving drug streptokinase has highlighted the mantra of ‘the process is the product’ in the case of biologicals [1].

Clinical trials for adalimumab biosimilars

Biosimilars/Research | Posted 15/05/2015

As part of their investigation into biosimilars for the treatment of psoriasis, researchers from the Charité – Universitätsmedizin Berlin, Germany, carried out a systematic review into clinical trials for adalimumab biosimilars [1].

Biosimilar filgrastim highly similar to originator filgrastim

Biosimilars/Research | Posted 08/05/2015

A study comparing Sandoz’s filgrastim biosimilar (Zarzio) with originator filgrastim (Neupogen) has shown that they are highly similar in terms of their structure and function [1].

Clinical trials of biosimilars for psoriasis treatment

Biosimilars/Research | Posted 08/05/2015

Tumour necrosis factor-alpha (TNF-alpha) is a cytokine, or protein, that prompts the body to create inflammation. In psoriasis and psoriatic arthritis, there is excess production of TNF-alpha in the skin or joints. Therefore, drugs that block TNF-alpha, such as Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab) and Stelara (ustekinumab), can be used to treat psoriasis and psoriatic arthritis.