Louis Tharp

The existence of CT-P13, a biosimilar version of infliximab (Remsima), and its recommended approval on Tuesday by the FDA Arthritis Advisory Committee, is reason to celebrate.  While this vote, and presumed FDA approval, will likely benefit patients, our optimism is tempered by not being able to predict if health insurance companies will return the savings to the patient community. CreakyJoints testified at the meeting saying:  “For us patients, biosimilars represent … expanded treatment options through a broader formulary, (but) we fear being switched from a drug that works to one we don’t know, without participating in the promised cost reductions.   “The FDA and … manufacturers can support this effort by …examining their supply chain and support services … creating unique naming and clear labeling to allay fears (and) finalizing the interchangeability rule that eliminates payer-level switching. The FDA needs to allow extrapolation, unless the mechanism of action for the extrapolated indication is not clearly understood or the drug is considered scientifically or therapeutically outdated,” we stated during the hearing.[[{"type":"media","view_mode":"media_crop","fid":"45808","attributes":{"alt":"Louis Tharp","class":"media-image media-image-right","id":"media_crop_2600022635888","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5266","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"Louis Tharp","typeof":"foaf:Image"}}]] Regarding the Remsima vote, there remain unknowns, especially with the infliximab IBD indication. We think the FDA should have parsed the indications, following Canada’s lead, and withheld the Crohn’s indication. Post-approval monitoring of biosimilars is essential. Through Arthritis Power, our PCORI-sponsoed Patient Powered Research Network, CreakyJoints is well-positioned to track patient-reported outcomes.  Our take-a-ways: 1.      There must be uninterrupted supply. Absent this, defacto – not FDA-directed – interchangeability will become the norm when biosimilar manufacturers cannot sustain production levels and patients must switch from one biosimilar to another.  2.       Safety should be a given. We and others need to look closely at the safety record of all biosimilar manufacturers to ensure possible cost-cutting does not impact safety.   3.      Patients currently enjoy support from reference biologic companies. We believe biosimilars from companies like Sandoz, Amgen, Pfizer and other well-known, established names, will offer these services, but will other companies? Chronic illness in the U.S. is still tougher than it should be for patients. Biosimilars can help.  

Louis Tharp is Executive Director and Co-Founder of the Global Healthy Living Foundation and CreakyJoints

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There must be uninterrupted supply of approved biosimilars and safety should be an utmost concern on all levels, CreakyJoints  says.

Author | Louis Tharp

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CreakyJoints Urges Uninterrupted Supply of Biosimilars