Thank you for attending last week’s CIBRN Webinar #1! Your opinions are welcome on the Sosido forum.

Thank you to those who attended last week’s webinar and to those who have already responded to questions 1-3 via the Sosido forum (see questions and links below). The discussions are still open and we encourage you to visit the CIBRN community on Sosido to review the questions & responses and to reply with your personal clinical perspectives:

Webinar for the CIBRN community presented by all CIBRN Leaders Thurs, June 8, 9:00 pm EST

Please join the CIBRN Leaders for an in-depth, cross-discipline discussion of CIBRN 2017 Question #1, Question #2 & Question #3 surrounding the implications of the evolving biosimilar landscape on clinical practice and patient health in Canada.

This webinar is intended for the ALL CIBRN members and is scheduled for Thursday, June 8th, 9:00-10:00 pm ESTWebinar connection details will follow by email.

Prior to the webinar, you are invited to visit the CIBRN community on Sosido to review the questions & responses and to reply with your personal clinical perspectives:

The webinar will be recorded and archived for future viewing by the CIBRN community.

If you have any comments or questions, please contact me at your convenience.

Paul Abbass
LEGITIMED INC.
Email: paul.abbass@legitimed.com

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If you have never attended an Adobe Connect meeting before:

Test your connection: https://studio7communications.adobeconnect.com/common/help/en/support/meeting_test.htm

Get a quick overview: http://www.adobe.com/products/adobeconnect.html

AGA Makes Six Recommendations to FDA on Interchangeable Biosimilars

Source: American Gastroenterological Association, May 25 2017

http://www.gastro.org/news_items/aga-makes-six-recommendations-to-fda-on-interchangeable-biosimilars/?

Gastroenterologists and patients rely on biologics to manage Crohn’s disease and ulcerative colitis. Biosimilar products, which are “highly similar” to the biologic, have begun to be approved by the FDA for such indications. The FDA is now developing a pathway for interchangeable products, which are biosimilars that “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product” according to Section 351(i) of the Public Health Service Act. Last week, AGA provided the FDA six recommendations in response to the agency’s draft guidance on demonstrating interchangeability focused on measures to enhance patient safety and ensure that physicians, not insurance companies, drive decisions about switching products. Here is a summary of our comments … [view full article]

View a Summary of the 2016 CIBRN Learning Program: Video Learning MicroModule Now Available Online

As we get ready to kick off our second year of the CIBRN learning program, we invite you to review the CIBRN micromodule video from the 2016 season. The video is under 20 minutes in length and will provide an overview of discussions surrounding structured questions authored by CIBRN Leaders.

Watch the 2016 CIBRN micromodules here:

English: http://studio7web.ca/clients/Legitimed/CIBRN_BiosimilarSummary/English/

Français: http://studio7web.ca/clients/Legitimed/CIBRN_BiosimilarSummary/French/

Recording of CIBRN Dermatology Webinar Now Available Online

We invite you to listen to an in-depth discussion of CIBRN Question #5 & Question #6, as presented by Dr. Gordon Searles, Dr. Ronald Vender and Dr. Mark Kirchhof, recorded at the CIBRN Dermatology Webinar, December 8, 2016. Link to recorded webinar.

CIBRN Question #5: Given that biosimilar trials are to be compared against the originator using a “most sensitive” indication or condition, how will the trial indication be selected for study? Link to discussion on Sosido.

CIBRN Question #6: Can the concept of extrapolation be used for biosimilars in patients with hidradenitis suppurativa given their major treatment differences? Link to discussion on Sosido.

Webinar for CIBRN Dermatology Subgroup, presented by Dr. Gordon Searles, Dr. Ronald Vender & Dr. Mark Kirchhof, Thurs, Dec 8, 7:00 pm EST

Please join Dr. Gordon Searles, Dr. Ronald Vender and Dr. Mark Kirchhof for an in-depth discussion of CIBRN Question #5 and Question #6 surrounding the implications of the evolving Biosimilar landscape on clinical practice and patient health in Canada.

This webinar is intended for the CIBRN Dermatology subgroup and is scheduled for Thursday, December 8th, 7:00-8:00pm EST. See instructions below:

Step 1: To join the audio portion:
Dial toll-free:  1-866-830-9434
Enter Participant Code: 7994216

Step 2: To join the web portion:
Click on link: https://studio7communications.adobeconnect.com/cibrn_dermatology/
Select ‘Next’
Select ‘Guest’
Enter your name
Select ‘Enter’

Prior to the webinar, you are invited to visit the CIBRN community on Sosido to review the questions & responses and to reply with your personal clinical perspectives. The webinar will be recorded and archived for future viewing by the CIBRN community.

If you have any comments or questions, please contact me at your convenience.

Paul Abbass
LEGITIMED INC.
Email: paul.abbass@legitimed.com

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If you have never attended an Adobe Connect meeting before:

Test your connection: https://studio7communications.adobeconnect.com/common/help/en/support/meeting_test.htm

Get a quick overview: http://www.adobe.com/products/adobeconnect.html

Recording of CIBRN Rheumatology Webinar Now Available Online

We invite you to listen to an in-depth discussion of CIBRN Question #3 & Question #4, as presented by Dr. Carter Thorne and Dr. Philip Baer, recorded at the CIBRN Rheumatology Webinar, December 1, 2016. Link to recorded webinar.

CIBRN Question #3: How confident can rheumatologists be in the results of the Nor-switch study to inform their biologic choices in everyday practice? Link to discussion on Sosido.

CIBRN Question #4: Given that patients in Nor-switch had been on an originator infliximab for a mean of 6+ years, is the rate of disease worsening over 1 year of 26-29% concerning regarding the face validity of the study? Link to discussion on Sosido.