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Samsung Bioepis and Organon
News

Samsung Bioepis and Organon’s Hadlima (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots:FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vialDesignation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO…
4 days ago

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Celltrion
News

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations

Shots:FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringesDesignation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
May 22, 2025

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Celltrion
News

Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation

Shots:The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab)Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was…
April 15, 2025

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Insights+ Key Biosimilars Events of October 2023
INSIGHTS+

Insights+ Key Biosimilars Events of October 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…
November 1, 2023

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VIEWPOINTS_Dr. Mourad Farouk Rezk1_2023
VIEWPOINTS

Dr. Mourad Farouk Rezk, Head of Global Medical & Development Biogen Biosimilars Shares Insights on Positive P-III Data for BIIB800 (Actemra biosimilar)

Shots :Dr. Mourad talked about the positive P-III data showing results for BIIB800, a Tocilizumab biosimilar candidate presented at the Annual European Congress of Rheumatology (EULAR 2022)He also spoke about the results of the 48-week analysis of the PROPER trial evaluating   adalimumab biosimilar, Imraldi, in patients with autoimmune diseasesThe interview highlights Biogen's…
June 27, 2023

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Insights+ Key Biosimilars Events of May 2020
INSIGHTS+

Insights+ Key Biosimilars Events of May 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyFresenius Kabi expanded its footprints with the acceptance of MAA and BLA of its MSB11455 (biosimilar, pegfilgrastim) in the EU and the US respectively, and also signed an agreement with Medec to commercialize Idacio (adalimumab, biosimilar) in…
June 5, 2020

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