Biosimilar Pipeline Quarterly Update: March 2023

Critical updates in an ever-changing environment

March 27, 2023

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 traditionaldrugs, specialty drugs and cell/gene therapies. 

New Drug Information

  • None

New Indications

  • None
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/ Organon Autoimmune SC August 2022
ranibizumab-eqrn

Interchangeable biosimilar

Cimerli® Lucentis® Coheres biosciences/bioeq Age-related macular degeneration Injection into the eye August 2022
pegfilgrastim-pbbk Fylnetra Neulasta® Amneal/ Kashiv (Adello) Neutropenia IV or SC May 2022
bevacizumab-maly Alymsys Avastin® mAbxience/ Insud Pharma/ Amneal Oncology IV April 2022
Biosimilar Pipeline
Generic Name Brand Name Manufacturer Indication(s) Route of Administration Anticipated Approval date*
Oncology
SB8 (bevacizumab biosimilar) N/A (Avastin® biosimilar) Samsung Bioepis/ Merck Oncology IV 2023
FKB238 (bevacizumab biosimilar) N/A (Avastin® biosimilar) Centus Biotherapeutics Oncology IV 2023
BAT-1706 (bevacizumab biosimilar) N/A (Avastin® biosimilar) Bio-thera solutions Oncology IV 2023
HLX02 (trastuzumab biosimilar) N/A (Herceptin® biosimilar) AccordBioPharma (Intas)/ Shanghai Henlius Biotech Oncology IV 2023
Blood Modifiers
pegfilgrastim Lupifil-p®  (Neulasta® biosimilar) Lupin Neutropenia SC 2023
pegfilgrastim Lapelga® (Neulasta® biosimilar) Apotex/Accord Neutropenia SC 2023
TX01 (filgrastim biosimilar) 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
MYL1701P (aflibercept) N/A (Eylea® biosimilar) Mylan Age-related macular degeneration Injection into the eye 2023
Autoimmune
CTP17 (adalimumab) Yuflyma® (Humira® biosimilar) Celltrion Autoimmune SC 2023
MSB11456 (tocilizumab) N/A (Actemra® IV/SC biosimilar) Fresenius Autoimmune IV/SC 2Q2023
BIIB800 (tocilizumab) N/A (Actemra® IV/SC biosimilar) Biogen Autoimmune IV/SC 10/2023
ABP654

(ustekinumab)

N/A (Stelara® SC biosimilar) Amgen Autoimmune SC 2H2023
AVT04

(ustekinumab)

N/A (Stelara® SC biosimilar) Alvogen/Alvotech Autoimmune SC 2H2023
Immunosuppressant
PB006 (natalizumab) N/A (Tysabri® biosimilar) Sandoz-Polpharma Multiple sclerosis IV 5/2023
Bone Health
GP2411 (denosumab) N/A (Prolia® biosimilar) Sandoz Osteoporosis SC 12/2023

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