Perspectives
Biosimilar Pipeline Quarterly Update: March 2023
Critical updates in an ever-changing environment
March 27, 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 traditionaldrugs, specialty drugs and cell/gene therapies.
New Drug Information
- None
New Indications
- None
Biosimilar Product Approvals in the Past Twelve Months
| Generic Name | Brand Name | Reference
Product |
Manufacturer | Indication(s) | Route of Administration | Month Approved |
| adalimumab-aacf | Idacio® | Humira® | Fresenius | Autoimmune | SC | December 2022 |
| insulin glargine-aglr
Interchangeable biosimilar |
Rezvoglar® | Lantus® | Eli Lilly | Diabetes | SC | November 2022 |
| bevacizumab-adcd | Vegzelma® | Avastin® | Celltrion | Oncology | IV | September 2022 |
| pegfilgrastim-fpgk | Stimufend® | Neulasta® | Fresenius Kabi | Neutropenia | IV or SC | September 2022 |
| adalimumab-bwwd 100mg/mL | Hadlima® HC | Humira® | Samsung Bioepis/ Organon | Autoimmune | SC | August 2022 |
| ranibizumab-eqrn
Interchangeable biosimilar |
Cimerli® | Lucentis® | Coheres biosciences/bioeq | Age-related macular degeneration | Injection into the eye | August 2022 |
| pegfilgrastim-pbbk | Fylnetra™ | Neulasta® | Amneal/ Kashiv (Adello) | Neutropenia | IV or SC | May 2022 |
| bevacizumab-maly | Alymsys™ | Avastin® | mAbxience/ Insud Pharma/ Amneal | Oncology | IV | April 2022 |
Biosimilar Pipeline
| Generic Name | Brand Name | Manufacturer | Indication(s) | Route of Administration | Anticipated Approval date* |
| Oncology | |||||
| SB8 (bevacizumab biosimilar) | N/A (Avastin® biosimilar) | Samsung Bioepis/ Merck | Oncology | IV | 2023 |
| 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 |
| HLX02 (trastuzumab biosimilar) | N/A (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 |
| TX01 (filgrastim biosimilar) | N/A (Neupogen® biosimilar) | Tanvex BioPharma | Neutropenia | SC | 2023 |
| filgrastim | Grastofil® (Neupogen® biosimilar) | Apotex/Accord | Neutropenia | SC | 2023 |
| Ophthalmology | |||||
| ranibizumab | Xlucane® (Lucentis® biosimilar) | Xbrane & Bausch | Age-related macular degeneration | Injection into the eye | 2023 |
| MYL1701P (aflibercept) | N/A (Eylea® biosimilar) | Mylan | Age-related macular degeneration | Injection into the eye | 2023 |
| Autoimmune | |||||
| CTP17 (adalimumab) | Yuflyma® (Humira® biosimilar) | Celltrion | Autoimmune | SC | 2023 |
| MSB11456 (tocilizumab) | N/A (Actemra® IV/SC biosimilar) | Fresenius | Autoimmune | IV/SC | 2Q2023 |
| BIIB800 (tocilizumab) | N/A (Actemra® IV/SC biosimilar) | Biogen | Autoimmune | IV/SC | 10/2023 |
| ABP654
(ustekinumab) |
N/A (Stelara® SC biosimilar) | Amgen | Autoimmune | SC | 2H2023 |
| AVT04
(ustekinumab) |
N/A (Stelara® SC biosimilar) | Alvogen/Alvotech | Autoimmune | SC | 2H2023 |
| Immunosuppressant | |||||
| PB006 (natalizumab) | N/A (Tysabri® biosimilar) | Sandoz-Polpharma | Multiple sclerosis | IV | 5/2023 |
| Bone Health | |||||
| GP2411 (denosumab) | N/A (Prolia® biosimilar) | Sandoz | Osteoporosis | SC | 12/2023 |
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