FDA approves Inflectra, a biosimilar to Remicade
Monday, 11 April 2016 09:18
On 5 April, the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. In the United States, Inflectra is approved and can be prescribed by a health care professional for the treatment of:
- adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy
- adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
as well as for several rheumatological conditions. The American College of Rheumatology responded to the announcement, welcoming the approval, and emphasised that "the safety of our patients remains our highest priority. As such, we encourage the FDA to continue to apply distinct names for future biosimilars, and to maximize clarity in the labeling of biosimilars, specifically with respect to their interchangeable status and the origins (reference drug versus biosimilar) of clinical data upon which FDA approval is based."
The American College of Rheumatology (ACR) had welcomed the FDA’s draft guidance (August 2015) recommending that biosimilars are clearly differentiated from their reference drugs. The ACR has been calling on the FDA to introduce stricter authorisation and labelling measures for biologics, issuing a position statement "on biosimilars that updates and clarifies the ACR’s positions on extrapolation, substitution, notification and labeling. More details are available from both the ACR and the Office of the Federal Register.
A total of £3,500 up for grabs in the 2016 Endoscopy Research Dragons' Den – apply now!
Thursday, 31 March 2016 10:23
The BSG Endoscopy Clinical Research Group (E-CRG) invites BSG members (trainees, nurses, and consultants in the first 5 years of their career in any area of gastroenterology) to submit their ideas for research projects.
Up to 5 ideas will be selected; the selected candidates will be asked to do a 6-minute presentation to a Dragons’ Den–type panel during the BSG 2016 Meeting (in Liverpool on Thursday 23 June 2015 from 14.45-15.30).
There is a total of £3500 to be awarded on the day, supported by unrestricted grants from Aquilant Endoscopy, the Devices for Surgery Network (Engineering and Physical Sciences Research Council and National Institute for Health Research Healthcare Technology Cooperative), Diagmed Healthcare and EMIS Health.
Prize-winners will be awarded up to £1000 as an unrestricted grant.
The E-CRG is solely responsible for all aspects of selecting the candidates; panellists will choose the winner(s) on the basis of the actual presentation on the day.
- Download application form [ 0.9 Mb ]
What role does a CTU play in developing an NIHR funding application?
Wednesday, 30 March 2016 09:07
The NIHR has produced a video highlighting the role that Clinical Trials Units (CTUs) play in developing an NIHR funding application, explaining both the role and benefits of working with CTUs.
CTUs are specialist units which have been set up with a specific remit to design, conduct, analyse and publish clinical trials. They bring together a range of trials expertise within one centre, working in a collaborative relationship with Principal Investigators in order to deliver high quality and efficient clinical trials. For more information, please go to the video's web page.
"HRA Approval" completes implementation on 31 March 2016
Monday, 21 March 2016 10:01
From 31 March 2016, HRA Approval will be the process for applying for approvals for all project-based research in the NHS led from England. HRA Approval is the new system that brings together the assessment of governance and legal compliance for the NHS in England with the independent REC opinion provided through the UK Health Departments’ Research Ethics Service.
For any new studies that are led from outside England but have English sites, the NHS permissions coordinating function of the lead nation will share information with the HRA Assessment team, who can issue HRA Approval for English sites and thereby retain existing compatibility arrangements.
This completes the phased roll out that has been underway since May 2015. NIHR CSP (Coordinated System for gaining NHS Permission) will be closed to new applications before the end of March. The timing of the closure of CSP has been agreed between the NIHR Clinical Research Network, the HRA and the devolved administrations.
Studies led from England that have already applied for REC review but have not applied for R&D review, or that need to add new NHS sites in England, or have new amendments, should be brought under HRA Approval so that NHS sites in England can work with sponsors under the new arrangements.
The HRA has closely monitored studies going through HRA Approval and revised processes as part of learning from and building on experience. Each phased roll out has built on the previous one. The latest phase includes:
- A mechanism for studies processed under pre-HRA Approval systems (eg. NIHR CSP and pre-CSP systems) to be brought under HRA Approval to add new NHS sites in England
- Amendments for all studies where the lead NHS R&D office is based in England being categorized by the HRA and handled in line with the existing UK Process for Handling UK Study Amendments alongside review by an NHS REC where applicable.
- HRA Approval being available to student studies led from England that require review by an NHS REC or are taking place across more than one NHS organisation.
Over the coming months, Radiation and Pharmacy Technical Assurances will be incorporated into HRA Approval as they roll out across the NHS.
HRA Approval is now the route for all project based research taking place in the NHS in England: portfolio, non-portfolio, commercial and non-commercial, those requiring review by an NHS REC and also those not requiring NHS REC review. HRA Approval does not apply to Research Tissue Banks, Research Databases and studies taking place only in non-NHS sites.
Please see the HRA Approval Programme section of the HRA website for details. This information will be incorporated into the applicant guidance pages of the HRA website on 31 March 2016.
If you have any queries or comments please contact us.
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