UPPER NYACK, N.Y.–(BUSINESS WIRE)–At the July 12 and July 13 Arthritis Advisory Committee meetings, Seth Ginsberg, President and Co-Founder of the Global Healthy Living Foundation and its arthritis support community, CreakyJoints, will provide public comment regarding arthritis and chronic disease patients’ perspective on biosimilars. The majority of the CreakyJoints members have rheumatoid arthritis (or other forms of autoimmune arthritis) and rely on biologic therapies in order to live fulfilling and productive lives. As a result, the organization has been educating the community of over 100,000 patients and caregivers living with chronic autoimmune diseases about biosimilars for the past five years as well as listening to understand what they need to know about biosimilars in order to have confidence in this developing product class.
New #Biosimilars to be evaluated next week @US_FDA Ask @SethSaidSo #chronicdisease patients’ perspective @GHLForg
AVAILABLE FOR INTERVIEW
- Seth Ginsberg, Co-Founder and President of the Global Healthy Living Foundation: IN PERSON (DAY OF) AND BY PHONE
- Steve Marmaras, Director of State and National Advocacy, Global Healthy Living Foundation: IN PERSON (July 12) AND BY PHONE
- Regan Reynolds, autoimmune arthritis patient from Raleigh, NC: BY PHONE
The July 12 Arthritis Advisory Committee meeting is being convened to discuss biologics license application 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.’s HUMIRA (adalimumab), submitted by Amgen, Inc. On July 13, the committee will discuss biologics license application 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc. The potential FDA approval of either of these medications is notable because the BLAs propose expansive indications that will reach millions of patients living with a wide range of chronic disease including rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn’s disease, severely active ulcerative colitis, active arthritis, psoriatic arthritis, and plaque psoriasis.
In his comments, Mr. Ginsberg will urge the FDA and manufactures to support the approval of these biosimilars to expand access to treatment options that have the potential to reduce costs for patients. However, he will also remark on some of the attributes of biosimilar manufacturers that GHLF’s community believes are necessary in order for them to feel confident taking biosimilars. Some of these attributes include safety track record, supply chain sustainability, support services, and negotiations with payers to ensure any savings achieved also reach the patient. Unique naming, clear labeling, as well as interchangeability that eliminates payer-level switching continue to be important issues for our patient community. Mr. Ginsberg will also express Global Healthy Living Foundation support of FDA extrapolation of indications only where there is evidence of overwhelming effectiveness, hence keeping less effective drugs off the biosimilar market.
About Global Healthy Living Foundation
The Global Healthy Living Foundation is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for people living with chronic illnesses by advocating for improved access to care at the community, state, and federal levels, and amplifying education and awareness efforts within its social media framework. The Global Healthy Living Foundation is the parent organization of CreakyJoints, the go-to source for more than 100,000 arthritis patients and their families world-wide who are seeking education, support, advocacy and patient-centered research and the recently launched ArthritisPower, the first ever patient-led, patient-centered research registry for arthritis, bone, and inflammatory skin conditions.
Global Healthy Living Foundation
Jessica Daitch, 917-816-6712