Biosimilar Pipeline Quarterly Update: September 2023

Critical updates in an ever-changing environment

September 25, 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 traditional drugs, specialty drugs and cell/gene therapies. 

New Drug Information

  • None

New Indications

  • None
Biosimilar Product Full Approvals in the Past Twelve Months
Generic Name Brand Name Reference

Product

Manufacturer Indication(s) Route of Administration Month Approved
natalizumab-sztn Tyruko™ Tysabri® Polpharma/Sandoz Multiple Sclerosis and Crohn’s disease IV August 2023
adalimumab-aaty Yuflyma® Humira® Celltrion Autoimmune SC May 2023
adalimumab-aacf Idacio® Humira® Fresenius Autoimmune SC December 2022
insulin glargine-aglr

Interchangeable biosimilar

Rezvoglar® Lantus® Eli Lilly Diabetes SC November 2022
Biosimilar Pipeline
Generic Name Brand Name Manufacturer Indication(s) Route of Administration Anticipated Approval date*
Oncology
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
SB8 (bevacizumab biosimilar) Aybintio ™ (Avastin® biosimilar) Samsung Bioepis/ Merck Oncology IV 2024
HLX02 (trastuzumab biosimilar) Zercepac® (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
pegfilgrastim Udenyca® OBI (Neulasta biosimilar) Coherus BioSciences Neutropenia On body device 2023
filgrastim Grastofil®  (Neupogen® biosimilar) Apotex/Accord Neutropenia SC 2023
Ophthalmology
MYL1701P (aflibercept) Yesafili™ (Eylea® biosimilar) Mylan Diabetic macular edema Eye injection 2023
CT-P42 N/A (Eylea® biosimilar) Celltrion Diabetic macular edema Eye injection 2024
FYB203 N/A (Eylea® biosimilar) Formycon/Klinge Diabetic macular edema Eye injection 2024
ranibizumab Xlucane (Lucentis® biosimilar) Xbrane/Bausch Age-related macular degeneration Eye injection 2024
Autoimmune
MSB11456 (tocilizumab) N/A (Actemra® IV/SC biosimilar) Fresenius Autoimmune IV/SC 2023
BIIB800 (tocilizumab) N/A (Actemra® IV/SC biosimilar) Biogen Autoimmune IV/SC 2023
ABP654

(ustekinumab)

N/A (Stelara® SC biosimilar) Amgen Autoimmune SC 2023
AVT04

(ustekinumab)

N/A (Stelara® SC biosimilar) Alvogen/Alvotech Autoimmune SC 2023
Immunosuppressant
           
Bone Health
GP2411 (denosumab) N/A (Prolia® biosimilar) Sandoz Osteoporosis SC 2023

 

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