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Patients 'sceptical' about biosimilars, says EULAR

Concerns for safety of drugs for arthritis and other musculoskeletal diseases

Drug discoveryPatients are anxious about being treated with biosimilar drugs and need access to clear information about trial data to allay their fears, according to a position paper published by the European League Against Rheumatism (EULAR).

While biosimilars have the potential to widen patient access to costly treatment, the science behind these new drugs is not easy for the public to understand and "the implications of treatment by biosimilars have attracted a certain amount of anxiety and scepticism among the patient community," it says.

Patients have raised questions about the approval process and safety of biosimilars for arthritis and other musculoskeletal diseases, are often confused by the concept of 'similarity' and concerned that this variability could increase immunogenicity or lead to other side effects.

EULAR's position paper seeks to explain the concepts in plain wording, and calls on the scientific community to provide "timely lay summaries of all results of relevant and important studies" to patients.

Biosimilars are one of the key themes of EULAR 2015 - currently ongoing in Rome - with several new studies on new candidates reported in the scientific sessions.

Among these, Celltrion has reported data from a 39-patient study of CT-P13, a biosimilar of Johnson & Johnson's widely-used tumour necrosis factor (TNF) inhibitor Remicade (infliximab), showing it is as effective as the reference product in the treatment of rheumatoid arthritis and ankylosing spondylitis.

In the trial patients were switched from Remicade to the biosimilar after a median of four year's treatment but exhibited no additional safety signals in 11 months of follow-up, according to the researchers. Immunogenicity of the biosimilar antibody was similar to the originator drug, they added. 

"A cost-effective treatment option like biosimilar infliximab will help to decrease the current and extensive burden on healthcare systems across Europe," commented Celltrion chief executive Stanley Hong. "These financial pressures can lead to rationing of biologic medicines like anti-TNFs."

Meanwhile, Biogen and partner Samsung Bioepis presented evidence that three of their biosimilar candidates were equivalent to their reference products. 

Phase III data found that Remicade biosimilar SB2 and SB4 - which mimics Amgen's anti-TNF drug Enbrel (etanercept) - performed as well as the originator drugs in head-to-head testing. 

In addition, a phase I pharmacokinetic study of SB5 - a biosimilar of AbbVie's TNF blocker Humira (adalimumab) - also found it was comparable.  Biogen has already filed for approval pf SB2 and SB4 while SB5 is in a phase III trial.

EULAR also saw presentations on EPIRUS Biopharmaceuticals' BOW015 infliximab biosimilar, including data from a phase III trial have been used to support regulatory filings in markets such as Latin America. Additional trials will be carried out later this year with a view to filing for approval in the US and Europe in 2017, said the company.

Hospira and Mundipharma already sell Celltrion's biosimilar infliximab under license in Europe and -once multiple candidates are available - pricing is expected to become even more competitive, potentially yielding as much as $50bn in savings to healthcare systems around the word between 2015 and 2025. 

CT-P13 has also been filed for approval in the US, although the regulatory pathway for biosimilars is only just starting to be opened up there, with just one drug approved to date.

"More than 120 million people are living with rheumatic and musculoskeletal diseases in the EU today," according to the EULAR paper. 

"Access to safe, effective and affordable medicine is of paramount importance to them."

Article by
Phil Taylor

12th June 2015

From: Regulatory



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