Biosimilar Pipeline Quarterly Update: December 2022

Critical updates in an ever-changing environment

December 29, 2022

This quarterly pipeline wrap-up provides a review of newly approved biosimilars, an update on the biosimilar pipeline and news of note on biosimilars in the approval process. See separate articles for updates on traditional drugs, specialty drugs and cell/gene therapies. 

New Drug Information

  • Idacio® (adalimumab-aacf): The U.S. Food and Drug Administration (FDA) approved Fresenius Kabi’s Idacio as a citrate free biosimilar referencing AbbVie’s Humira (adalimumab). This is the eighth Humira biosimilar that has been approved in the U.S. Idacio will be offered in a citrate-free, low-concentration formulation in a prefilled syringe or prefilled autoinjector pen. It will not be seeking interchangeability status.1 Idacio is scheduled to launch September 30, 2023 with pricing to follow.

New Indications

  • None

References

  1. https://www.healio.com/news/rheumatology/20221214/fda-approves-fresenius-kabis-idacio-as-eighth-adalimumab-biosimilar
BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Reference

Product

Manufacturer Indication(s) Route of Administration Month Approved
adalimumab-aacf Idacio® Humira® Fresenius Autoimmune SC December 2022
insulin glargine-aglr

interchangeable biosimilar

Rezvoglar® Lantus® Eli Lilly Diabetes SC November 2022
bevacizumab-adcd Vegzelma® Avastin® Celltrion Oncology IV September 2022
pegfilgrastim-fpgk Stimufend® Neulasta® Fresenius Kabi Neutropenia IV or SC September 2022
adalimumab-bwwd 100mg/mL Hadlima® HC Humira® Samsung Bioepis and Organon Autoimmune SC August 2022
ranibizumab-eqrn First interchangeable biosimilar for Lucentis Cimerli® Lucentis® Coheres biosciences/bioeq Age-related macular degeneration Injection into the eye August 2022
pegfilgrastim-pbbk Fylnetra Neulasta® Amneal and Kashiv (Adello) Neutropenia IV or SC May 2022
bevacizumab-maly Alymsys Avastin® mAbxience, Insud Pharma; Amneal Oncology IV April 2022
filgrastim-ayow Releuko Amneal® Neutropenia Blood modifying IV February 2022
BIOSIMILAR PIPELINE
Generic Name Brand Name Manufacturer Indication(s) Route of Administration Anticipated Approval date*
Oncology
MYL-1402O N/A (Avastin® biosimilar) Mylan NV and Biocon Ltd. Oncology IV 2023
SB8 N/A (Avastin® biosimilar) Samsung Bioepis and Merck Oncology IV 2023
FKB238 N/A (Avastin® biosimilar) Centus Biotherapeutics Oncology IV 2023
BAT-1706 N/A (Avastin® biosimilar) Bio-thera solutions Oncology IV 2023
EG12014 N/A (Herceptin® biosimilar) Sandoz Oncology IV 2023
Blood Modifiers
pegfilgrastim Lupifil-p®  (Neulasta® biosimilar) Lupin Neutropenia SC 2023
pegfilgrastim Lapelga® (Neulasta® biosimilar) Apotex/Accord Neutropenia SC 2023
TX01 N/A (Neupogen® biosimilar) Tanvex BioPharma Neutropenia SC 2023
filgrastim Grastofil®  (Neupogen® biosimilar) Apotex/Accord Neutropenia SC 2023
Ophthalmology
ranibizumab Xlucane®  (Lucentis® biosimilar) Xbrane & Bausch Age-related macular degeneration Injection into the eye 2023
MYL-1701P N/A (Eylea® biosimilar) Mylan Age-related macular degeneration Injection into the eye 2023
Autoimmune
CT-P17 Yuflyma® (Humira® biosimilar) Celltrion Autoimmune SC 2023
MSB11456 N/A (Actemra® IV/SC biosimilar) Fresenius Autoimmune IV/SC 2Q2023
BIIB800 N/A (Actemra® IV/SC biosimilar) Biogen Autoimmune IV/SC 10/2023
ABP 654 N/A (Stelara® SC biosimilar) Amgen Autoimmune SC 2H2023
AVT04 N/A (Stelara® SC biosimilar) Alvogen/Alvotech Autoimmune SC 2H2023
Immunosuppressant
PB006 (natalizumab) N/A (Tysabri® biosimilar) Sandoz-Polpharma Multiple sclerosis   5/2023

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