Later today, the US Food and Drug Administration (FDA) Arthritis Advisory Committee meets to discuss recommending the product CT-P13 (branded Remsima/Inflectra outside the US), a biosimilar of Janssen’s monoclonal antibody Remicade (infliximab).
The hearing was initially scheduled for March 2015, but was postponed due to statistical analyst demands by the Agency on the sponsor.
But in a pre-meeting briefing document published Friday, the FDA has found the structural and functional properties of the clinical and commercial product lots of Celltrion’s product to be “highly similar, notwithstanding minor differences in clinically inactive components,” to Remicade.
Extrapolation
Remicade is a rheumatoid arthritis (RA) drug, but has also been approved for seven other indications in the US, including ankylosing spondylitis, plaque psoriasis, and Crohn’s disease.
Celltrion is seeking licensure across all the same indications, having “provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity” across the seven additional conditions.
Several infliximab biosimilars are already available in other markets, with authorities taking different stances on extrapolation data. And Remicade maker Janssen said it hopes the FDA takes a conservative approach to extrapolation today.
“We respectfully disagree [on data extrapolation] and note that both safety and efficacy outcomes are important considerations,” chief biotechnology officer, Jay Siegel, told Biopharma-Reporter.
“It has been demonstrated that clinical trials of anti-TNFs in rheumatoid arthritis are not sensitive to differences that emerge in the treatment of inflammatory bowel disease (IBD). A careful assessment of clinical and analytical data must be weighed to demonstrate safety and efficacy and scientifically justify extrapolation.”
In Europe extrapolation to all indications have been approved, while in Canada and Israel extrapolation to IBD indications (Crohn’s disease and ulcerative colitis) has not been granted.
“Our hope is that the FDA Arthritis Advisory Committee engages in a robust scientific discussion focused on patient well-being,” Siegel added. “We fully support efforts to implement regulatory standards for the development and approval of biosimilars that ensure there are no clinically meaningful differences between the biosimilars and the reference products with respect to the high standards of safety and efficacy.
Erring on the side of caution
We also spoke with Seth Ginsberg, President and Co-Founder of patient group CreakyJoints, part of the non-profit Global Healthy Living Foundation who, while looking forward to more accessiblity and affordability through the entry of biosimilars in the US, hopes the FDA will err on the side of caution with regards to extrapolation in today’s meeting.
“Our hope is that extrapolation occur only on indications where the medicine is considered best-in-class, and not occur for an indication that is not clearly understood or for a drug that is considered scientifically or therapeutically outdated.”
If CT-P13 is recommended by today’s panel, it will be one step closer to becoming only the second biosimilar product – and the first monoclonal antibody copycat – to be approved in the US, following last year’s approval and launch of Sandoz’s Zarxio (filgastrim).