FDA’s first advisory committee for a 351(k) biosimilar application will include a cellular therapy manufacturing researcher along with clinicians and other specialists.

The Oncologic Drugs Advisory Committee is set to meet Jan. 7 to discuss Sandoz Inc.’s filgrastim biosimilar, which has the proposed proprietary name Zarxio. Committee members will consider whether the product is highly similar to its reference product (Amgen Inc.’s Neupogen), as well as if it should be approved for all five of Neupogen’s indications.

Sandoz was the first company to announce it had submitted an application under FDA’s biosimilar pathway. Two other applications also were publicly disclosed in the subsequent months ([A#14141217004]).

There will be 15 committee members for the meeting, 14 of which will be eligible to vote, according to the draft committee roster. Seven are part of the standing committee roster, while the remainder are considered temporary members. ODAC Chair Deborah Armstrong will run the meeting and will be joined by biostatistics, medical oncology and other experts in the midst of terms on the committee (see chart below).

David Stroncek, chief of the cell processing section at the National Institutes of Health Clinical Center, is among the temporary committee members.

Stroncek’s group conducts research intended to improve development, evaluation and validation of new manufacturing processes for cellular therapies and manufactures cellular therapy products for clinical trials, according to the NIH website. The expertise should be useful as the committee works to understand the biosimilar manufacturing issues FDA raised in its briefing document.

FDA also added pharmacology and pharmaceutical sciences experts as temporary members in Scott Waldman of Thomas Jefferson University and Donald Mager of the University of Buffalo. Both may help the committee better understand the process of showing no clinically meaningful differences between a biosimilar and its reference product (see related story,[A#14150105002]).

The committee’s composition was one of a number of issues observers were watching as the advisory committee meeting approached ([A#00141222013]).

Expertise will be important because the biosimilar development process is significantly different from traditional drug development, with many committee members unfamiliar with the approach of relying primarily on analytical data rather than clinical data as they would with a traditional BLA ([A#14141208004]).

Indeed, FDA’s meeting agenda includes an hour-long presentation and question-and-answer session on the 351(k) regulatory pathway.

Industry representative Howard Fingert, of Takeda Pharmaceutical Co. Ltd.subsidiaryMillennium, also may offer interesting input, even though he will not have a vote in the final decision. Takeda recently launched Entyvio (vedolizumab) for ulcerative colitis, an indication that is expected to soon include biosimilar competition ([A#14141112002]).

Oncolgic Drugs Advisory Committee Roster For Sandoz’s Filgrastim Biosimilar
ODAC Members and Affiliation	Expertise
Deborah K. Armstrong (Chairperson) Oncology professor, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Johns Hopkins University School of Medicine	Medical oncology and cancer genetics
Bernard Cole Professor, University of Vermont Department of Mathematics and Statistics	Biostatistics
Tito Fojo Senior investigator and director of the medical oncology fellowship program, National Cancer Institute Medical Oncology Branch, Center for Cancer Research	Medical oncology
James Liebmann Assistant professor of medicine, University of Massachusetts Department of Medicine	Medical oncology
Bruce Roth Professor of medicine, Washington University School of Medicine Division of Oncology	Medical oncology
Jane Zones (Consumer representative) Retired medical sociologist, member and former board member of Breast Cancer Action, National Women’s Health Network	Medical sociology and health policy
Howard Fingert (Industry representative, non-voting) Senior medical director of clinical intelligence, Millennium	Hematology and oncology
Temporary ODAC Members
Name	Affiliation
William Bensinger	Director of the autologous stem cell transplant program, Fred Hutchinson Cancer Research Center, professor of medicine, University of Washington School of Medicine Division of Oncology
Randy Hillard (Patient representative)	Physician
Ginna Laport	Clinical research director and professor of medicine, Stanford University Medical Center Division of Blood and Marrow Transplantation
Donald Mager	Associate professor of pharmaceutical sciences, University of Buffalo School of Pharmacy and Pharmaceutical Sciences Department of Pharmaceutical Sciences
Antonio Moreira	Vice provost for academic affairs and professor in the Department of Chemical, Biochemical and Environmental Engineering at the University of Maryland Baltimore County
Kathleen Neville	Associate professor of pediatrics and director of experimental therapeutics in pediatric cancer, Children’s Mercy Hospitals and Clinics Divisions of Pediatric Hematology/Oncology and Pediatric Pharmacology and Medical Toxicology
David Stroncek	Chief of the Cell Processing Section, National Institutes of Health Clinical Center Department of Transfusion Medicine
Scott Waldman	Samuel M.V. Hamilton Professor and Chair, Thomas Jefferson University Sidney Kimmel Medical College Department of Pharmacology and Experimental Therapeutics
FDA Participants
Name	Title
Steven Kozlowski	Director of the Office of Biotechnology Products
John Jenkins	Director of the Office of New Drugs
Leah Christl	Associate director for therapeutic biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team
Richard Pazdur	Director of the Office of Hematology and Oncology Products
Ann Farrell	Director of the Division of Hematology Products
Source: Oncologic Drugs Advisory Committee briefing documents

FDA Adds Temporary Expertise To ODAC For Filgrastim Biosimilar Meeting

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