October 27, 2021

Volume XI, Number 300

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October 27, 2021

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Positive FDA Advisory Committee Vote for First Monoclonal Antibody Biosimilar – But Will Patent Dispute Delay Launch?

Tuesday, February 9th was a busy day for Korean biologics company Celltrion Inc.  The company had its proposed biosimilar CT-P13 before the FDA Arthritis Advisory Committee as well as a hearing in federal court in Massachusetts as part of the patent dispute with the manufacturer of the reference biologic, Remicade (infliximab), Janssen Biotech.  At the end of the day, CT-P13 – which would be the first monoclonal antibody approved under the FDA’s biosimilar program – received the support of Arthritis Advisory Committee members. The outcome of yesterday’s hearing in the patent litigation remains unknown.  When factual issues are not in dispute, FDA typically follows the advice of its expert advisory committees on approval and/or restrictions on new products, so we expect final approval of the Celltrion product in the coming months.   Remicade is a blockbuster drug, with estimates of over $4 billion in sales annually in the U.S. alone, so the anticipated approval of a biosimilar version of infliximab has significance for health care providers, payors, and patients as well as investors.

©1994-2021 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume VI, Number 41
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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

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