《生物相似藥》FDA核准第9個Humiira生物相似藥 南韓Celltrion的 Yuflyma 預計2023年七月美國上市 (附FDA核准九家公司表)
南韓生物相似藥大廠Celltrion表示，該公司Humira生物相似藥Yuflyma (adalimumab-aaty)將於2023年的七月美國上市。
2023年5月被FDA核准的Yuflyma 是一種高濃度（100mg/mL）、不含檸檬酸鹽的adalimumab單抗生物類似藥，將以預裝注射器和自動注射器給藥方式提供給患者。這是FDA第九個核准的Humira生物相似藥 (下表)。
FDA 批准生物相似藥8 種適應症: 類風濕關節炎、幼年特發性關節炎、銀屑病關節炎、強直性脊柱炎、克羅恩病、潰瘍性結腸炎、斑塊狀銀屑病和化膿性汗腺炎。
Yuflyma (adalimumab-aaty)
是 Celltrion Healthcare 開發的第五個生物類似藥和第二個抗腫瘤壞死因子生物類似藥，獲得 FDA 批准。Yuflyma 也在歐盟和加拿大獲得批准。美國在2023 年 1 月核准Humira 生物類似藥安進公司的 Amjevita 。在 2023 年 7 月之前，Yuflyma將成為唯一與原廠Humira競爭的第一個生物相似藥。七月之後，接著Coherus將以原廠價15%提供Humira之生物相似藥YUSIMRY (連結)。
|
Brand |
Non-Proprietary Name |
Company |
FDA Approval |
Anticipated Launch Date |
Interchangeability Designation? |
High/Low- Concentration? |
|
Amjevita |
adalimumab-atto |
Amgen |
September 2016;approval for high-concentration version expected in 2024 |
Launched; high-concentration version expected in 2024 |
No |
Low; high-concentration version in phase 3 trials |
|
Cvltezo |
adalimumab-adbm |
Boehringer Ingelheim |
August 2017 |
July 2023 |
Yes |
Low |
|
Hadlima |
adalimumab-bwwd |
Organon/Samsung Bioepis |
July 2019 |
July 2023 |
No; Approval for interchangeability is expected post-launch |
Both |
|
Hulio |
adalimumab-fkjp |
Mylan/Viatris/Biocon/ Fujifilm Kyowa Kirin |
lulv 2020 |
July 2023 |
No |
Low |
|
Yusimrv |
adalimumab-agvh |
Coherus BioSciences |
December 2021 |
July 2023 |
No |
Low |
|
Abrilada |
adalimumab-afzb |
Pfizer |
November 2019 |
July 2023 |
Application for interchangeability is under review |
Low |
|
Hyrimoz |
adalimumab-adaz |
Sandoz/Novartis |
October 2018 |
July 2023 |
No |
Both |
|
Idacio |
adalimumab-aacf |
Fresenius Kabi |
December 2022 |
July 2023 |
No |
Low |
|
Yuflyma |
adalimumab-aaty |
Celltrion |
May 2023 |
July 2023 |
Filed application to conduct trial investigating interchangeability |
High |
|
AVTOZ |
N/A |
Alvotech/Teva Pharmaceuticals |
Approval pending (expected May 2023) |
|
Application for interchangeability is under review (expected in Q4 2024) |
High |
