Perspectives
Biosimilar Pipeline Quarterly Update: September 2022
September 30, 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
- Stimufend® (pegfilgrastim-fpgk): Fresenius Kabi’s Stimufend was approved by the FDA as a pegfilgrastim biosimilar. Stimufend is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Stimufend is the fifth approved pegfilgrastim biosimilar using Amgen’s Neulasta as a reference product. The company expects to launch the product in a prefilled syringe early next year and in an on-body injector following FDA approval with pricing to follow.1
BIOSIMILAR PRODUCT APROVALS IN THE PAST TWELVE MONTHS
| Generic Name | Brand Name | Reference
Product |
Manu-facturer | Indication(s) | Route of Administration | Month Approved |
| pegfilgrastim-fpgk | Stimufend® | Neulasta® biosimilar | Fresenius Kabi | Neutropenia | IV or SC | September 2022 |
| adalimumab-bwwd 100mg/mL | Hadlima® HC | Humira® biosimilar | Samsung Bioepis and Organon | Autoimmune | SC | August 2022 |
| ranibizumab-eqrn First interchangeable biosimilar for Lucentis | Cimerli® | Lucentis® biosimilar | 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 |
| 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 interchangeable 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 | 4Q2022 | |
| TX05 | N/A (Herceptin® biosimilar) | Tanvex | Oncology | IV | 2022 | |
| Blood Modifiers | ||||||
| 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 | |
| Ophthalmology | ||||||
| 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 | |
| Autoimmune | ||||||
| CT-P17 | Yuflyma® (Humira® biosimilar) | Celltrion | Autoimmune | SC | 2022 | |
| MSB11022 | Idacio® (Humira® biosimilar) | Fresenius | Autoimmune | SC | 2022 | |
| MSB11456 | N/A (Actemra® IV/SC biosimilar) | Fresenius | Autoimmune | IV/SC | 2Q2023 | |
REFERENCES
- https://www.fresenius-kabi.com/news/fresenius-kabi-receives-us-fda-approval-for-biosimilar
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