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By Bronwyn Mixter
Jan. 8 — Twenty-three patient groups Jan. 6 sent a letter to the House Energy and Commerce Committee asking for hearings on biosimilar drugs and patient safety as the FDA creates regulations to implement the biosimilars approval pathway.
The groups, all members of the Patients for Biologics Safety & Access (PBSA), said they are requesting the hearings “to assure that patient safety is being fully protected as” the Food and Drug Administration implements the Biologics Price Competition and Innovation Act. The BPCIA, part of the Affordable Care Act, created a pathway for the FDA to approve follow-on biologic drugs, or biosimilars. Thus far, the FDA has approved one biosimilar under that law.
The groups said, “While our communities are eager for new and affordable treatments, patients with rare and chronic diseases are keenly aware of the possible risks associated with biologics and biosimilars, including immunogenicity and the lack of long-term safety data for new treatments.” The groups include the Arthritis Foundation and the Crohn's & Colitis Foundation of America.
The patient groups said they believe that “greater transparency is needed surrounding the development and implementation of the biosimilars approval pathway.”
The FDA has accepted eight biosimilar applications and approved one biosimilar drug, but hasn't yet issued final guidance on “crucial patient safety issues such as naming, labeling, interchangeability standards, and indication extrapolation,” the letter said. “We would like to see those guidances issued and finalized with full input from those who will take and prescribe biosimilars—patients and their health professionals.”
“The complexity and uniqueness of each biologic medicine requires that FDA ensure that all biologics and biosimilars are thoroughly tested and meet the highest safety standards,” the letter said. “Given the importance of this issue to patient safety and the impending actions by the FDA both to develop biosimilar approval standards and consider pending applications, we urge you to schedule BPCIA oversight hearings before your committee early this year and ensure patient voices are represented at such hearings.”
In March 2015, the FDA approved the first biosimilar in the U.S. That biosimilar product is Zarxio, a Sandoz biosimilar of Amgen's cancer drug Neupogen (filgrastim) (45 HCDR, 3/9/15).
The FDA told Bloomberg BNA in a Jan. 8 e-mail that it doesn't have a comment on the letter.
Daniel Seaton, a spokesman for the Biotechnology Innovation Organization (BIO), told Bloomberg BNA Jan. 8 that BIO “shares the concern voiced by these patient groups on the need for final guidance from the FDA on the implementation of the BPCIA, including on naming, labeling and interchangeability standards.”
Patient safety “is dependent upon a regulatory framework which provides full, transparent and distinguishable information for all biological products, and we urge the FDA to issue final guidance providing for such,” he said. “To that end, BIO would support a hearing of the House Energy and Commerce Committee to ensure that stakeholder perspectives, particularly those of provider and patient groups, are heard and their concerns incorporated as the FDA continues implementing the biosimilars approval pathway contained in the BPCIA.”
A representative of a generic drug industry group declined to comment on the letter.
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