As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order:
1) Launch of First and Second U.S. Trastuzumab Biosimilars: In July 2019, Amgen and Allergan announced the U.S. launch of KANJINTI (trastuzumab-anns), which became the first commercially available biosimilar to Genentech’s HERCEPTIN on the U.S. market. Later in the year, Mylan and Biocon announced the U.S. launch of their OGIVRI (trastuzumab-dkst) biosimilar. Both KANJINTI and OGIVRI are FDA-approved for all approved indications of HERCEPTIN: for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. KANJINTI is the subject of ongoing BPCIA litigation, whereas OGIVRI was launched pursuant to a settlement.
2) Launch of First U.S. Bevacizumab Biosimilar: Also in July, Amgen and Allergan announced the U.S. launch of MVASI (bevacizumab-awwb), the first commercially available biosimilar to Genentech’s AVASTIN (bevacizumab) in the U.S. MVASI is approved by the FDA for treating certain patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, or persistent, recurrent, or metastatic cervical cancer. Amgen is currently engaged in BPCIA litigation against Genentech regarding this biosimilar.
3) Launch of First U.S. Rituximab Biosimilar: In November, Teva and Celltrion announced that they launched TRUXIMA (rituximab-abbs) in the U.S., becoming the first commercially available biosimilar to Genentech’s RITUXAN. TRUXIMA is approved for use in certain patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis. The launch followed a litigation settlement.
4) Launch of Additional U.S. Pegfilgrastim Biosimilars: In January 2019, Coherus launched UDENYCA (pegfilgrastim-cbqv), the second biosimilar to Amgen’s NEULASTA in the U.S., following the previous commercial launch of Mylan’s FULPHILA (pegfilgrastim-jmdb). Later, in November 2019, Sandoz launched a third U.S. pegfilgrastim biosimilar, ZIEXTENZO (pegfilgrastim-bmez). All three biosimilars are indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. All three biosimilars were the subject of separate BPCIA litigations, but each case was resolved in 2019: Coherus and Sandoz, with an appellate victories, and Mylan, with a stipulated judgment of non-infringement.
5) Collaboration for Phase 3 U.S. Ranibizumab Biosimilar Candidate: In November, Bioeq and Coherus announced that they entered into a license and development agreement under which Coherus will exclusively market and distribute Bioeq’s phase 3 biosimilar candidate to LUCENTIS (ranibizumab) in the United States. Bioeq indicated in its announcement that it would be responsible for submitting an aBLA to the FDA for the biosimilar candidate in the fourth quarter of 2019, and that Coherus planned to launch the product in 2021. Presently, there are not any FDA-approved biosimilars to LUCENTIS (ranibizumab), which is approved for the treatment of patients with wet age-related macular degeneration, diabetic retinopathy, diabetic macular edema, myopic choroidal neovascularization, and macular edema following retinal vein occlusion.
Please see a comprehensive list of FDA-approved and launched biosimilars on our website.
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