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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…
2 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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Top 20 Biopharma 2025
TOP 20

Top 20 Biopharma Companies of 2025 

Shots: Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
April 24, 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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Viewpoints_Uwe Gudat
VIEWPOINTS

Biocon Biologics at EADV Congress 2024: Uwe Gudat in a Stimulating Dialogue Exchange with PharmaShots

Shots: At the European Academy of Dermatology and Venereology (EADV) 2024 Congress, Biocon Biologics presented results from two pivotal P-III clinical studies. These studies supported the interchangeability between Humira and adalimumab-fkjp, as well as the biosimilarity between Bmab 1200 and Stelara for the treatment of patients with moderate-to-severe plaque psoriasis In an engaging conversation with…
January 6, 2025

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Prescription Drugs Top 20 2024
TOP 20

Top 20 Prescription Drugs of 2024

Shots:Driven by an endless pursuit of innovation, the biopharma industry is working tirelessly to bring new-age therapies to patients with serious health conditions and lifestyle-influenced diseasesIn 2023, the global prescription drug market size was valued at $1162.61B and is anticipated to reach $2151.63B by 2032 registering a CAGR of 7.1 %. Keytruda ranks 1st…
October 31, 2024

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Monoclonal Antibodies Top 20 2024
TOP 20

Top 20 Monoclonal Antibodies of 2024

Shots:Transforming care with advanced mechanisms of action, monoclonal antibody therapies hold a strong foothold in the healthcare marketIn 2021, the monoclonal antibody therapy market size was valued at $178.5B and is envisioned to reach $451.89B by 2028, displaying a CAGR of 14.1%. Keytruda with $25.01B revenue ranks first in our list followed by…
September 12, 2024

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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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