Perspectives
Biosimilar Pipeline Quarterly Update: September 2023
Critical updates in an ever-changing environment
September 25, 2023This 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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