Biosimilar Pipeline Quarterly Update: June 2022

July 13, 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 therapy

New Drug Information

  • Fylnetra® (pegfilgrastim-pbbk): The FDA approved Amneal’s Fylnetra (pegfilgrastim-pbbk) a leukocyte growth factor biosimilar to Neulasta® (pegfilgrastim) used to reduce the incidence of neutropenia in patients undergoing chemotherapy. Fylnetra is the fifth Neulasta biosimilar, other biosimilars include: Mylan/Biocon’s Fulphila® (pegfilgrastim-jmdb), Pfizer’s Nyvepria™ (pegfilgrastim-apgf), Coherus BioSciences’ Udenyca® (pegfilgrastim-cbqv) and Sandoz’s Ziextenzo® (pegfilgrastim-bmez) which are already available in the U.S. None of the biosimilars are interchangeable with Neulasta or with each other.1 According to IQVIA®, U.S. annual sales for pegfilgrastim for the 12 months ended March 2022 were $3.1 billion, $1.0 billion of which represented biosimilar sales.2 Amneal is planning on launching Fylnetra the second half of 2022 with pricing to follow.

 

BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS
Generic Name Brand Name Reference

Product

Manufacturer Indication(s) Route of Admin Month Approved
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 interchange-able 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 2022  
TX05 N/A (Herceptin® biosimilar) Tanvex Oncology IV 2022  
Blood Modifiers          
MSB11455 Stimufend® (Neulasta® biosimilar) Fresenius Kabi Neutropenia IV or SC 2022  
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  
Ophthomology          
FYB201 Cimerli® (Lucentis® biosimilar) Coheres biosciences/bioeq Age-related macular degeneration Injection into the eye 2022  
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  
BIOSIMILAR PIPELINE
Drug Name Generic drug name Manufacturers Route of Admin Indication Stage
Hadlima Adalimumab Organon; Samsung Bioepis Injectable Juvenile idiopathic arthritis; Ulcerative colitis; Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Crohn’s disease; Plaque psoriasis; Pending (08/2022)  
TX05 Trastuzumab Tanvex Injectable HER2-positive breast cancer Pending (08/2022)  
Cimerli Ranibizumab bioeq; Coherus BioSciences; Formycon; Polpharma; Santo Holding; Swiss Pharma International AG Intravitreal Wet age-related macular degeneration Pending (08/02/2022)  
Abrilada Adalimumab Pfizer Subcutaneous Juvenile idiopathic arthritis; Ulcerative colitis; Rheumatoid arthritis; Psoriatic arthritis; Ankylosing spondylitis; Crohn’s disease; Plaque psoriasis;  Pending (4Q 2022)  
CT-P16 Bevacizumab Celltrion Intravenous Non-small cell lung cancer (NSCLC) Pending (4Q 2022)  
EG12014 Trastuzumab EirGenix; Sandoz Intravenous HER2-positive breast cancer; Gastroesophageal cancer; Gastric cancer Pending (4Q 2022)  
Idacio Adalimumab Fresenius Subcutaneous Rheumatoid arthritis; Plaque psoriasis Pending (4Q 2022)  
AVT02 Adalimumab Alvogen; Alvotech; Teva Subcutaneous Plaque psoriasis Pending (12/2022)  
BAT1706 Bevacizumab Bio-Thera Solutions; Sandoz Intravenous Metastatic kidney cancer; Colorectal cancer; Cervical cancer; Glioblastoma multiforme; Non-small cell lung cancer (NSCLC) Pending  
Bmab-100 Bevacizumab Biocon; Mylan; Viatris Intravenous Non-small cell lung cancer (NSCLC); Glioblastoma multiforme; Colorectal cancer; Metastatic kidney cancer; Cervical cancer Pending  
FKB238 Bevacizumab AstraZeneca; Centus Biotherapeutics; Fujifilm Kyowa Kirin Intravenous Non-small cell lung cancer (NSCLC) Pending  
Grastofil Filgrastim Accord; Apotex; Intas Intravenous; Subcutaneous Cancer patients receiving bone marrow transplant; Cancer patients receiving myelosuppressive chemotherapy; Severe chronic neutropenia; Acute myeloid leukemia patients receiving induction or consolidation chemotherapy; Patients undergoing peripheral blood progenitor cell collection and therapy Pending  
Lapelga Pegfilgrastim Accord; Apotex; Intas Subcutaneous Cancer patients receiving myelosuppressive chemotherapy Pending  
Lupifil-P Pegfilgrastim Lupin Subcutaneous Cancer patients receiving myelosuppressive chemotherapy Pending  
MSB11455 Pegfilgrastim Dr. Reddy’s; Fresenius Subcutaneous Cancer patients receiving myelosuppressive chemotherapy Pending  
MYL-1701P Aflibercept Biocon; Janssen; Momenta; Mylan; Viatris Intravitreal Diabetic macular edema Pending  
SB8 Bevacizumab Organon; Samsung Bioepis Intravenous Non-small cell lung cancer (NSCLC) Pending  
TX01 Filgrastim Tanvex Injectable Severe chronic neutropenia Pending  
Yuflyma Adalimumab Celltrion Subcutaneous Rheumatoid arthritis Pending  
REFERENCES
  1. https://endpts.com/look-out-neulasta-a-5th-biosimilar-is-coming/
  2. https://www.drugs.com/newdrugs/fda-approves-fylnetra-pegfilgrastim-pbbk-biosimilar-neulasta-5838.html

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