Perspectives
Biosimilar Pipeline Quarterly Update: June 2022
July 13, 2022This 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
- https://endpts.com/look-out-neulasta-a-5th-biosimilar-is-coming/
- https://www.drugs.com/newdrugs/fda-approves-fylnetra-pegfilgrastim-pbbk-biosimilar-neulasta-5838.html
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