On July 12th and 13th, the FDA’s Arthritis Advisory Committee, held two meetings, to discuss proposed biosimilars to adalimumab (July 12th) and etanercept (July 13th). 

 

Nine ASBM members provided oral or written testimony at one or both of the meetings.  

 

Many of those testifying expressed concern with the FDA’s practice of approving biosimilars in indications in which they were not clinically evaluated, based on extrapolation from clinical data in other indications. Said ASBM’s Chairman Harry Gewanter, MD, in a statement: 

 

“We believe the approval of a biosimilar should be decided on a case-by-case basis for each potential indication based on sufficient supporting data rather than justifying an automatic blanket extrapolation to all indications. Ultimately, the burden of proof must be on the biosimilar manufacturer to demonstrate that their product is highly similar in structure, function and in patient response to the reference product.”

 

Andrew Spiegel, Executive Director of the Global Colon Cancer Association (an ASBM Steering Committee Member), expressed concerns with the approval process in his statement: 

 

“Extrapolation is also an area of concern to the patient community. At a minimum, approval for each indication should be granted individually, rather than an all-or-nothing approach. We don’t suggest that safe extrapolation is not possible, we simply think each indication should be approved individually based on solid data. This panel should have flexibility, and not be forced to approve the drug for all or no indications.” 

Mr. Spiegel cited the more cautious approach taken by Health Canada to approve a biosimilar to infliximab. While approved for Rheumatoid Arthritis (RA) and Ankylosing Spondilitis (AS), additional clinical data was required before approval was granted for IBD indications (Ulcerative Colitis and Crohn’s Disease) two years later. 

 

Mr. Spiegel also joined other patient advocates in urging the FDA to oppose the practice of Non-Medical Switching, particularly with non-interchangeable biosimilars: 

 

“Treatment decisions, including the decision to switch from one medicine to another should be made for medical reasons that benefit the health and safety of the patient, not for non-medical reasons that might benefit a a company’s shareholders”, said Spiegel.

 

Read more about the AAC Meetings here.