WASHINGTON, Feb. 9, 2016 /PRNewswire-USNewswire/ -- On
Tuesday, February 9th, the U.S. Food and Drug Administration
(FDA) met with its Arthritis Advisory Committee to discuss
Celltrion's Remsima, a proposed biosimilar of Johnson &
Johnson's Remicade and most likely the second biosimilar to be
approved in the U.S. The Biologics Prescribers Collaborative (BPC)
along with five other physician groups - Alliance for Patient
Access, American Association of Clinical Endocrinologists,
Coalition of State Rheumatology Organizations, American College of
Rheumatology, and Endocrine Society - submitted a comment to FDA's
Arthritis Advisory Committee acknowledging the agency's continuing
commitment and careful deliberation on biosimilar-related issues.
While this new type of treatment option could change the face of
medicine, their availability will increase the complexity of the
treatment landscape and this meeting represented an important step
towards expanding patient access to these lifesaving therapies.
Twenty-one members of the Arthritis Advisory Committee
recommended the FDA approve this biosimilar candidate, while three
members voted "no" that the FDA should not approve the application.
Committee discussion included many of the safety and efficacy
issues that need to be addressed as biosimilars market continues to
grow. It is imperative that sound policies are in place to
promote the fully informed and safe use of biosimilars. Therefore,
BPC asks the FDA to consider the following factors as
biosimilar-related policies are implemented:
- Each biological product needs a distinguishable non-proprietary
name
- Biosimilar product labeling must contain all needed data for
physicians to make appropriate prescribing decisions for their
patients
- Proceed with extreme caution when considering biosimilar
application requests for indication extrapolation
With nearly 60 biosimilar products awaiting FDA's approval, BPC
looks forward to additional advisory committee hearings and will
continue providing the critical perspective of biologics
prescribers to ensure patient safety.
The full statement to FDA's Arthritis Advisory Committee can be
found below or on the BPC website:
http://biologicsprescribers.org/resources/comment-to-the-arthritis-advisory-committee-regarding-bla-125544
For additional information, please contact BPC's lead physician
co-convener Dr. Dennis R. Cryer,
M.D., 202-525-2737.
February 3, 2016
Comment to the Arthritis Advisory Committee
RE: February 9, 2016 meeting to
discuss biologics license application (BLA) 125544
Stephanie L. Begansky, PharmD
Center for Drug Evaluation and Research, Food and Drug
Administration
10903 New Hampshire Avenue (WO31-2417)
Silver Spring, MD 20993-0002
AAC@fda.hhs.gov
As physicians who routinely prescribe biologic medicines and on
behalf of professional organizations with numerous biologics
prescribers as members, the Biologics Prescribers Collaborative
(BPC) supports sound policies that promote the fully informed and
safe use of biologics, including biosimilars, for all
patients.
We appreciate this opportunity to share our perspective on
issues critical for the safe use of biosimilars, as well as other
biologics, before the Arthritis Advisory Committee. Our comments
will therefore be general, addressing these issues rather than a
specific biosimilar.
First, each biological product needs a distinguishable
non-proprietary name.
FDA's draft guidance calls for all biological products to bear a
nonproprietary name that includes a four-letter suffix. We agree
with FDA, which explained, "there is a need to clearly identify
biological products to improve pharmacovigilance, and, for the
purposes of safe use, to clearly differentiate among biological
products that have not been determined to be interchangeable."
However, our experience as biologics prescribers tells us that in
addition to being unique, the suffix must also be memorable.
The randomized four-letter code proposed by the agency may
complicate pharmacovigilance and permit inadvertent substitution. A
memorable suffix that reflects the license-holding manufacturer
equips patients, physicians and pharmacists to accurately recall or
ascertain specifics about the biosimilar that may differ from those
of the originator, such as approved indications, administration
routes or delivery systems. It will also facilitate prompt,
accurate adverse event reporting by patients and physicians to the
correct manufacturer, and mandated manufacturer reporting to
FDA.
Second, biosimilar product labeling must contain all needed
data for physicians to make appropriate prescribing decisions for
their patients.
The label is a critical tool for physicians to make prescribing
decisions and manage potential adverse events, including side
effects and drug-drug interactions. As such, it is of the utmost
importance that any drug label be complete and accurate. A
biosimilar label identical to that of its reference product omits
readily available, product-specific data and may imply that a
biosimilar is interchangeable with the reference product and
approved for all of the same indications when it may not be.
Further, given that a biosimilar – unlike a generic small
molecule – has its own clinical data, there will likely be specific
information from this data package that will help physicians,
including the provision of information on immunogenicity, which can
vary from the reference biologic. Greater transparency and
inclusion of data will protect patients while increasing physician
confidence in the use of biosimilars and encouraging greater and
informed utilization.
Third, FDA should proceed with extreme caution when
considering biosimilar application requests for indication
extrapolation.
Biologic medicines are often used to treat multiple and
unrelated disease states and indications. Historically, when a new
biologic medicine has been approved for a disease state, complete
clinical trials have been conducted. FDA reviews that data in
making its determination. Under the new abbreviated approval
process, data is presented for certain indications but not for
others. As FDA considers which disease states and indications a
particular application receives approval for, we urge caution in
approving medicines for diseases for which no clinical data is
being produced. Simply because one biologic medicine has proven
effective in multiple disease states does not ensure that a
biosimilar product will have the same effect or efficacy. FDA
should continue to act to ensure the utmost safety and confidence
in new medicines.
We thank FDA for allowing us to submit these comments to the
Arthritis Advisory Committee. This comment is submitted by specific
members of the Biologics Prescribers Collaborative
including:
Alliance for Patient Access
American Association of Clinical Endocrinologists
Coalition of State Rheumatology Organizations
American College of Rheumatology
Endocrine Society
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/bpc-statement-on-fda-arthritis-advisory-committee-meeting-300217820.html
SOURCE Biologics Prescribers Collaborative