Biosimilar Pipeline Quarterly Update: September 2022

September 30, 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

  • Stimufend® (pegfilgrastim-fpgk): Fresenius Kabi’s Stimufend was approved by the FDA as a pegfilgrastim biosimilar. Stimufend is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Stimufend is the fifth approved pegfilgrastim biosimilar using Amgen’s Neulasta as a reference product. The company expects to launch the product in a prefilled syringe early next year and in an on-body injector following FDA approval with pricing to follow.1
BIOSIMILAR PRODUCT APROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Reference

Product

Manu-facturer Indication(s) Route of Administration Month Approved
pegfilgrastim-fpgk Stimufend® Neulasta® biosimilar Fresenius Kabi Neutropenia IV or SC September 2022
adalimumab-bwwd 100mg/mL Hadlima® HC Humira® biosimilar Samsung Bioepis and Organon Autoimmune SC August 2022
ranibizumab-eqrn First interchangeable biosimilar for Lucentis Cimerli® Lucentis® biosimilar 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
insulin glargine-aglr Rezvoglar Lantus® Eli Lilly Diabetes SC December 2021
adalimumab-aqvh Yusimry Humira® Coherus Autoimmune SC December 2021
ranibizumab-nuna Byooviz Lucentis® Samsung Bioepis Age-related macular degeneration Intravitreal September 2021
insulin glargine-yfgn

First interchangeable biosimilar for Lantus

Semglee Lantus® Mylan and Biocon Diabetes SC July 2021

 

 

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 2022  
SB8 N/A (Avastin® biosimilar) Samsung Bioepis and Merck Oncology IV 2022  
FKB238 N/A (Avastin® biosimilar) Centus Biotherapeutics Oncology IV 2022  
BAT-1706 N/A (Avastin® biosimilar) Bio-thera solutions Oncology IV 2022  
CT-P16 N/A (Avastin® biosimilar) Celltrion Oncology IV 2022  
EG12014 N/A (Herceptin® biosimilar) Sandoz Oncology IV 4Q2022  
TX05 N/A (Herceptin® biosimilar) Tanvex Oncology IV 2022  
Blood Modifiers            
lupifil-p N/A (Neulasta® biosimilar) Lupin Neutropenia SC 2022  
lapelga N/A (Neulasta® biosimilar) Apotex/Accord Neutropenia SC 2022  
TX01 N/A (Neupogen® biosimilar) Tanvex BioPharma Neutropenia SC 2022  
grastofil N/A (Neupogen® biosimilar) Apotex/Accord Neutropenia SC 2022  
Ophthalmology            
xlucane N/A (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 2022  
Autoimmune            
CT-P17 Yuflyma® (Humira® biosimilar) Celltrion Autoimmune SC 2022  
MSB11022 Idacio® (Humira® biosimilar) Fresenius Autoimmune SC 2022  
MSB11456 N/A (Actemra® IV/SC biosimilar) Fresenius Autoimmune IV/SC 2Q2023  
REFERENCES
  1. https://www.fresenius-kabi.com/news/fresenius-kabi-receives-us-fda-approval-for-biosimilar

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