Biosimilars/Research

Benefits and concerns related to biosimilars

Biosimilars/Research | Posted 18/03/2016

As patents of the first introduced biological therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the originator agent. This follows the pattern of the development of generics. However, biosimilars are fundamentally different from generics. Particularly in the field of oncology, the introduction of monoclonal antibodies has resulted in spectacular therapeutic advances by increasing the cure rate of early cancers and prolonging survival. Similar advances have occurred in rheumatology, haematology, neurology and other fields. Most therapeutic biologicals are monoclonal antibodies with molecular weights of around 140,000 Daltons [1]. Other peptides include hormones, growth factors and vaccines [2]. Most of those products are expensive and their broad application drains the financial resources of healthcare systems. Therefore, the development of biosimilars is expected to be mutually beneficial for both the pharmaceutical industry and society: pharmaceutical companies may enter a lucrative business, whereas payers reasonably expect lower prices for these costly but essential drugs.

Pharmacovigilance compliance for biocomparables in Mexico

Biosimilars/Research | Posted 16/10/2015

Filgrastim is widely used in Mexico, as in other countries. Its patent has expired and hence several non-originator biologicals have appeared. Following WHO guidelines, the General Health Law of Mexico was modified in 2009 to provide a solid regulatory environment for biosimilars (or biocomparables as they are called in Mexico) [1].

Naming affects pharmacists’ perceptions and dispensing of biosimilars

Biosimilars/Research | Posted 06/01/2017

A study of pharmacists, carried out jointly by the Academy of Managed Care Pharmacy (AMCP) and the Hematology/Oncology Pharmacy Association (HOPA), found that pharmacists had a preference for distinguishable names. However, the study also found that using the same names for interchangeable biologicals would make pharmacists more likely to dispense biosimilars [1].

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