Perspectives
Biosimilar Pipeline Quarterly Update: December 2022
Critical updates in an ever-changing environment
December 29, 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 therapies.
New Drug Information
- Idacio® (adalimumab-aacf): The U.S. Food and Drug Administration (FDA) approved Fresenius Kabi’s Idacio as a citrate free biosimilar referencing AbbVie’s Humira (adalimumab). This is the eighth Humira biosimilar that has been approved in the U.S. Idacio will be offered in a citrate-free, low-concentration formulation in a prefilled syringe or prefilled autoinjector pen. It will not be seeking interchangeability status.1 Idacio is scheduled to launch September 30, 2023 with pricing to follow.
New Indications
- None
References
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 and Organon | Autoimmune | SC | August 2022 |
| ranibizumab-eqrn First interchangeable biosimilar for Lucentis | Cimerli® | Lucentis® | 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 |
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 | 2023 |
| SB8 | N/A (Avastin® biosimilar) | Samsung Bioepis and Merck | Oncology | IV | 2023 |
| FKB238 | N/A (Avastin® biosimilar) | Centus Biotherapeutics | Oncology | IV | 2023 |
| BAT-1706 | N/A (Avastin® biosimilar) | Bio-thera solutions | Oncology | IV | 2023 |
| EG12014 | N/A (Herceptin® biosimilar) | Sandoz | Oncology | IV | 2023 |
| Blood Modifiers | |||||
| pegfilgrastim | Lupifil-p® (Neulasta® biosimilar) | Lupin | Neutropenia | SC | 2023 |
| pegfilgrastim | Lapelga® (Neulasta® biosimilar) | Apotex/Accord | Neutropenia | SC | 2023 |
| TX01 | 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 |
| MYL-1701P | N/A (Eylea® biosimilar) | Mylan | Age-related macular degeneration | Injection into the eye | 2023 |
| Autoimmune | |||||
| CT-P17 | Yuflyma® (Humira® biosimilar) | Celltrion | Autoimmune | SC | 2023 |
| MSB11456 | N/A (Actemra® IV/SC biosimilar) | Fresenius | Autoimmune | IV/SC | 2Q2023 |
| BIIB800 | N/A (Actemra® IV/SC biosimilar) | Biogen | Autoimmune | IV/SC | 10/2023 |
| ABP 654 | N/A (Stelara® SC biosimilar) | Amgen | Autoimmune | SC | 2H2023 |
| AVT04 | N/A (Stelara® SC biosimilar) | Alvogen/Alvotech | Autoimmune | SC | 2H2023 |
| Immunosuppressant | |||||
| PB006 (natalizumab) | N/A (Tysabri® biosimilar) | Sandoz-Polpharma | Multiple sclerosis | 5/2023 | |
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