Biosimilar drug approvals soared in 2019

Sandra Levy
Senior Editor
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2019 was a very good year for biosimilar drug approvals. The Food and Drug Administration’s Center for Drug Evaluation and Research’s annual report, "Advancing Health Through Innovation: New Drug Therapy Approvals," highlights ten biosimilars that received the FDA's blessing.  

“Biosimilars have great potential for both patients and the entire health care system. As patents and exclusivity protections for biologics expire in the United States, we can expect many more biosimilars to be submitted for approval. More products on the market means greater competition that can lead to increased access to therapies and lower costs to patients," said Janet Woodcock, CDER director.

In 2019, CDER approved the following new biosimilars:

  • Avsola (infliximab-axxq), the fourth biosimilar to Remicade (infliximab), approved for a variety of uses including, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis. CDER approved Inflectra (infliximab-dyyb) in 2016, and Ixifi (infliximab-qbtx) and Renflexis (infliximababda) in 2017;
  • Eticovo (etanercept-ykro), the second biosimilar to Enbrel (etanercept). It is approved to treat the same conditions as Enbrel, which include rheumatoid arthritis, various other forms of arthritis and plaque psoriasis. CDER approved the first Enbrel biosimilar, Erelzi (etanercept-szzs), in 2016;
  • Hadlima (adalimumab-bwwd) and Abrilada (adalimumab-afzb) respectively the fourth and fifth biosimilars to Humira (adalimumab). These drugs are tumor necrosis factor inhibitors that suppress the immune system. They are approved for a variety of uses, including rheumatoid arthritis, juvenile idiopathic arthritis in patients 4 years and older, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, psoriatic arthritis, and plaque psoriasis. CDER approved Amjevita (adalimumab-atto), the first biosimilar to Humira, in 2016. The second, Cyltezo (adalimumab-adbm), was approved in 2017, and the third, Hyrimoz (adalimumabadaz), was approved in 2018;
  • Ontruzant (trastuzumab-dttb), Trazimera (trastuzumab-qyyp), and Kanjinti (trastuzumab-anns) respectively, the third, fourth, and fifth biosimilars to Herceptin (trastuzumab), to treat patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. CDER approved the first Herceptin biosimilar, Ogivri (trastuzumab-dkst), in 2017 and the second, Herzuma (trastuzumab-pkrb), in 2018;
  • Ruxience (rituximab-pvvr), the second biosimilar to Rituxan (rituximab), approved to treat adult patients with CD-20-positive, B-cell non-Hodgkin’s lymphoma, a type of blood cancer, to be used as a single agent or in combination with chemotherapy, and to treat CD-20-positive, chronic lymphocytic leukemia (a type of blood cancer) in combination with chemotherapy. Ruxience is also the first biosimilar approved to treat adult patients with granulomatosis with polyangiitis and microscopic polyangiitis. CDER approved the first biosimilar to Rituxan, Truxima (rituximab-abbs), in 2018.; 
  • • Ziextenzo (pegfilgrastim-bmez), the third biosimilar to Neulasta (pegfilgrastim) approved to treat patients with cancer receiving myelosuppressive chemotherapy. CDER approved the first and second biosimilars to Neulasta, Fulphila (pegfilgrastim-jmdb) and Udenyca (pegfilgrastim-cbqv), in 2018;
  • • Zirabev (bevacizumab-bvzr), the second biosimilar to Avastin (bevacizumab). Zirabev is a monoclonal antibody used to prevent the growth of certain types of tumors. It is FDA approved for the following indications currently approved for U.S.-licensed Avastin: metastatic colorectal cancer; nonsquamous non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma, and cervical cancer. CDER approved the first Avastin biosimilar, Mvasi (bevacizumab-awwb), in 2017.

CDER now has approved a total of 26 biosimilars for nine different reference products since 2015. This includes at least one biosimilar for each of these top-selling biological drugs in the United States: Humira, Rituxan, Enbrel, Herceptin, Avastin, Remicade, and Neulasta. Two biological reference products (Humira and Herceptin) now have five biosimilars; one (Remicade) has four biosimilars; one reference product (Neulasta) has three biosimilars, four reference products (Avastin, Enbrel, Neupogen, and Rituxan) have two biosimilars and one reference product (Epogen/Procrit) has one biosimilar.

“Multiple biosimilars for an FDA approved reference product can strengthen market competition. An increase in market competition may lead to significantly reduced costs for both patients and our healthcare system,” Woodcock said.