FDA Touts Biosimilar Approvals in Annual CDER Report

January 8, 2020

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

The FDA highlighted biosimilar approvals in its annual report of 2019 drug approvals released this week.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research.

The biosimilar approvals “will further help to create competition, increase patient access, and potentially reduce the cost of important biological drug therapies,” the FDA said.

The 10 biosimilar approvals span indications for rheumatoid arthritis, plaque psoriasis, breast cancer, metastatic stomach cancer, metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma, cervical cancer, B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

The approvals include:

  • The fourth approved biosimilar infliximab, Amgen’s Avsola.
  • The second biosimilar etanercept, Samsung Bioepis’ Eticovo (referencing Enbrel).
  • Two adalimumab products, Hadlima and Abrilada, respectively the fourth and fifth biosimilars to Humira.
  • Three biosimilars for trastuzumab, Ontruzant, Trazimera, and Kanjinti; they are the third, fourth, and fifth biosimilars to reference trastuzumab, Herceptin.
  • Ruxience, the second biosimilar rituximab referencing the originator, Rituxan.
  • Ziextenzo, the third pegfilgrastim biosimilar to originator product Neulasta.
  • Pfizer’s biosimilar bevacizumab (Zirabev) the second biosimilar to Avastin. Zirabev launches in the United States January 13, 2020.

CDER has now approved a total of 26 biosimilars for 9 different reference products since 2015. In 2018 the FDA approved 59 novel drugs.


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