Biosimilars/Research

Positive phase III results for Boehringer’s adalimumab biosimilar

Biosimilars/Research | Posted 06/01/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 26 October 2016 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Positive phase III results for Celltrion’s rituximab biosimilar

Biosimilars/Research | Posted 09/12/2016

Phase III studies of a rituximab biosimilar from Celltrion have, according to the company, shown that the biosimilar is ‘equivalent’ to Roche’s MabThera/Rituxan (rituximab).

Positive results for etanercept and bevacizumab biosimilars

Biosimilars/Research | Posted 09/12/2016

A phase III study of an etanercept biosimilar from Sandoz and a phase I study of a bevacizumab biosimilar from Boehringer Ingelheim have, according to the companies, shown the biosimilars to be ‘bioequivalent’ (bevacizumab) or have ‘equivalent’ safety and efficacy (etanercept) compared to their respective originator biologicals.

Biosimilars help reduce the costs of cancer care

Biosimilars/Research | Posted 02/12/2016

The costs for cancer drugs have been increasing significantly in countries around the world. With the arrival of new therapies, the future of cancer care is exciting. But how will healthcare systems be able to pay for such innovations? In their commentary, Goldstein and co-authors discuss how biosimilars could help alleviate such challenges [1].

Safety differences in clinical trials for biosimilars

Biosimilars/Research | Posted 25/11/2016

Differences in safety evaluations and findings between clinical trials for biosimilars are highlighted by researchers from the University of Massachusetts, USA and Newcastle University in the UK. This they argue is a reason for clinical trial design for biosimilars to be standardized [1].

Extrapolation of indications for biosimilar infliximab and etanercept

Biosimilars/Research | Posted 18/11/2016

Biosimilar infliximab (Inflectra/Remsima) was approved in Europe in September 2013 for the same indications as the originator product (Remicade). More recently, biosimilar etanercept (Benepali) was approved in Europe in January 2016 for the same indications as the originator product (Enbrel) [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the extrapolation of the indications for the biosimilars [2].

Trials for biosimilar etanercept

Biosimilars/Research | Posted 11/11/2016

Biosimilar etanercept was approved in Europe in January 2016 [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the trials that led to the approval of biosimilar etanercept [2].

Differences in efficacy assessment in clinical trials for biosimilars

Biosimilars/Research | Posted 11/11/2016

Clinical trial design should be standardized according to researchers from the University of Massachusetts, USA and Newcastle University in the UK [1]. They argue that a ‘standard clinical trial design be adopted for all biosimilars of a particular [originator biological] in a given disease’.

Trials for biosimilar infliximab

Biosimilars/Research | Posted 04/11/2016

Biosimilar infliximab was launched in the UK in March 2015. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the trials that led to the approval of biosimilar infliximab [1].

Biosimilars in nephrology in the US

Biosimilars/Research | Posted 04/11/2016

Biosimilars are biological medicines that are highly similar to the reference product with no meaningful clinical differences in terms of safety, purity and potency. All biologicals are produced by living cells resulting in an inherent heterogeneity in their higher order structures and post-translational modifications.

Standardizing clinical trials for biosimilars

Biosimilars/Research | Posted 28/10/2016

Researchers from the University of Massachusetts, USA and Newcastle University, UK argue that clinical trial design should be standardized for future studies of biosimilars [1]. Indeed, they argue that a ‘standard clinical trial design be adopted for all biosimilars of a particular [originator biological] in a given disease’.

Study design for biosimilar trials

Biosimilars/Research | Posted 28/10/2016

Biosimilars have been available in the field of rheumatology since 2015. In light of this fact, researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss study design for biosimilar trials [1].

NOR-SWITCH study finds biosimilar infliximab not inferior to originator

Biosimilars/Research | Posted 21/10/2016

Results of a two-year phase IV study have shown that Celltrion Healthcare (Celltrion)’s infliximab biosimilar (Remsima, CT-P13) is not inferior to the originator biological Remicade.

Biosimilars versus generics

Biosimilars/Research | Posted 21/10/2016

Since 2015, biosimilars have been available in the field of rheumatology. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London discuss how such biosimilars differ from the more traditional generics [1].

Biosimilars: clinicians and regulators need to talk

Biosimilars/Research | Posted 05/08/2016

In Europe, there is a clear gap between the regulatory decisions that govern biosimilar approval and the recommendations of medical societies. The fact that the views of medical societies, whose members are the physicians that will prescribe biosimilars, disagree with those of regulators, may hold back biosimilar uptake.

Use of biosimilar anti-TNF in Australia

Biosimilars/Research | Posted 14/10/2016

With the advent of biosimilar anti-tumour necrosis factor (TNF), new options have opened up for the treatment of inflammatory bowel disease (IBD) in Australia. Author Richard B Gearry of the University of Otago, Christchurch, New Zealand, discusses what needs to be taken into consideration when physicians prescribe anti-TNF products [1].

Positive phase III results for Mylan’s biosimilar pegfilgrastim

Biosimilars/Research | Posted 14/10/2016

Results of a study of Biocon and Mylan’s comparing Biocon/Mylan’s biosimilar pegfilgrastim (MYL-1401H) to the originator (Neulasta) has ‘demonstrated equivalent efficacy’, according to Mylan [1].

Biosimilars in rheumatology

Biosimilars/Research | Posted 07/10/2016

In 2015, the rheumatology community saw the emergence of the first biosimilars onto the market. Biosimilars are not new to the medical community at large, having been on the market in the European Union (EU) since 2006. However, their arrival into the field of rheumatology is new and, according to researchers from the National Health Service (NHS) Foundation Trust and King's College London, ‘comes with great anticipation’ [1].

Switching may not be suitable for patients with immunogenicity

Biosimilars/Research | Posted 30/09/2016

Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; CT-P13) versions has shown ‘cross-immunogenicity’ between the originator and biosimilar in patients with rheumatic diseases [1].

Efficacy and safety of biosimilar infliximab in children with IBD

Biosimilars/Research | Posted 30/09/2016

Researchers from Birmingham Children’s Hospital presented results from a study of the use of the infliximab biosimilar CT-P13 (Remsima/Inflectra) in children with inflammatory bowel disease (IBD) [1].

Positive phase III results for Sandoz etanercept biosimilar

Biosimilars/Research | Posted 23/09/2016

Results of a study of Sandoz’s etanercept biosimilar (GP2015) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have shown ‘equivalent efficacy’, according to the company.

Study supports interchangeability of TNF-α biosimilars

Biosimilars/Research | Posted 16/09/2016

For years, the costs of drugs have been rising. Prescription drug spending in the US rose by 12.6% in 2014 and almost 1 in 4 Americans report difficulty affording their prescriptions. A familiar situation in many countries, the escalating costs of drugs make them unaffordable for a large part of the world.

More positive phase I results for Coherus pegfilgrastim biosimilar

Biosimilars/Research | Posted 16/09/2016

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 11 July 2016 that follow-on results from a phase I study of its candidate pegfilgrastim biosimilar (CHS 1701) were positive.

Biosimilars for use in fertility treatment

Biosimilars/Research | Posted 09/09/2016

As patents expire on originator products, there is increasing interest in developing biosimilars globally. Authors Raoul Orvieto and David Seifer from the Sheba Medical Center and Sackler Faculty of Medicine of the Tel Aviv University in Israel investigated biosimilars used in fertility treatment [1].

Safety and efficacy of Remsima in IBD patients in clinical practice

Biosimilars/Research | Posted 09/09/2016

Researchers from Spain presented results from a study of the use of the infliximab biosimilar Remsima in ulcerative colitis disease patients in clinical practice after six months treatment.

Use of biosimilars in oncology in France

Biosimilars/Research | Posted 02/09/2016

Biosimilar drugs are biological drugs clinically similar to their reference products. They correspond to a generic drug approach applied to biological agents. The goal of biosimilars is to open the market and to provide significantly less costly biological agents. The approval of biosimilars is abbreviated when compared to that of the reference biologicals, but includes clinical trials (distinguishing them from generics). In oncology, the currently available biosimilars filgrastim and epoetin alfa are used in supportive care. Author Dominique Leveque from the Hôpital Hautepierre, Strasbourg, France discusses the situation regarding the use of biosimilars in France [1].

Biosimilar manufacturers fail to compete in Italy

Biosimilars/Research | Posted 30/08/2013

In the current global economic crisis, significant savings on healthcare spending should be made as a result of increased competition between manufacturers of off-patent biologicals or biosimilars. If only that were so, writes Professor Livio Garattini at the Centre for Health Economics, Ranica, Italy [1], who has analysed the pricing of off-patent biologicals in Italy, a country particularly hard hit by the economic downturn.

Assessment of interchangeability under the BPCI Act

Biosimilars/Research | Posted 22/02/2013

The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician [1]. The criteria for establishing interchangeability of biosimilars, despite FDA issuing three draft guidance documents, are still not clear [2].

The ethics of biosimilars

Biosimilars/Research | Posted 22/02/2013

Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical level. Only if a biosimilar is a close copy of the reference medicine will it be approved as a biosimilar [1]. Despite this fact, however, ethical issues have been raised on the use of granulocyte colony-stimulating factor (G-CSF, filgrastim) in healthy volunteers by the European Group for Blood and Marrow Transplantation (EBMT) and the World Marrow Donor Association (WMDA).

Assessment of biosimilarity under the BPCI Act

Biosimilars/Research | Posted 08/02/2013

The Biologics Price Competition and Innovation (BPCI) Act defines a biosimilar as a product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and without clinically meaningful differences in terms of safety, purity, and potency. Although draft guidances issued by FDA do begin to clarify the issue, little or no discussion regarding how similar is considered highly similar is given in the BPCI Act and no criteria for assessing biosimilarity were mentioned [1].

G-CSF biosimilars – World Marrow Donor Association position

Biosimilars/Research | Posted 08/02/2013

The World Marrow Donor Association (WMDA) has expressed its position on the use of granulocyte colony-stimulating factor (G-CSF) biosimilars in healthy donors in an article published in the journal Haematologica [1].

Biosimilarity and interchangeability under the BPCI Act

Biosimilars/Research | Posted 24/01/2013

In the US, the Biologics Price Competition and Innovation (BPCI) Act was signed into law on 23 March 2010, giving FDA the authority to approve biosimilars. FDA then issued guidelines for biosimilar applications in February 2012 in the form of three draft guidance documents [1]. Despite this, there remain scientific issues regarding the assessment biosimilars and the criteria for establishing biosimilarity and interchangeability of biosimilars [2].

Biosimilar terminology confusion

Biosimilars/Research | Posted 26/10/2012

Imprecise usage of the term biosimilar in the literature is an issue that has already been highlighted by EMA [1].

Pharmaceutical price regulation in Saudi Arabia: a countdown to affordable biosimilars

Biosimilars/Research | Posted 26/08/2016

The pricing of pharmaceuticals and biosimilars is generally subject to national regulatory control. Regulation is in place to ensure pharmaceutical affordability, yet enable profitability for pharmaceutical companies and facilitate innovation. A recent paper on pharmaceutical price regulation in Saudi Arabia by Alhomaidan et al. [1], charts the regulatory procedures in place, and outlines how their evolution has led to today’s regulated pricing of biosimilars.

Positive phase III results for Amgen’s trastuzumab biosimilar

Biosimilars/Research | Posted 26/08/2016

Results of a study of Amgen and Allergen’s trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab) have ‘ruled out inferiority’, according to the company.

Positive clinical data for three anti-TNF-α biosimilars

Biosimilars/Research | Posted 29/07/2016

Results of studies of three biosimilars from Samsung Bioepis, Benepali (etanercept), Flixabi (infliximab) and candidate biosimilar SB5 (adalimumab), have shown ‘comparable outcomes with regards to both the efficacy and safety of treatment’ when compared to their respective reference products, according to the company [1-3].

Mylan presents comparability data for trastuzumab biosimilar

Biosimilars/Research | Posted 01/07/2016

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.

Epoetin alfa biosimilar effective in treating anaemia

Biosimilars/Research | Posted 25/03/2016

Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA) [1].

Evolution of biosimilars in developed and developing countries

Biosimilars/Research | Posted 19/08/2016

The development of biologicals has experienced continuous growth over the past three decades. The expiration of patent protection for many biologicals has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilars and covers their therapeutic status, clinical trials, approved biosimilars and regulatory guidelines in Japan, South Korea and Malaysia [1].

Biosimilars: the benefits need to be communicated

Biosimilars/Research | Posted 12/08/2016

Extrapolation may be the most contentious issue of biosimilar development, but it is also its single greatest benefit, says Dr Martina Weise of the Federal Institute for Drugs and Medical Devices in Germany.