Skip to content Skip to footer
Subscribe Now
Henlius & Organon
NEWS

Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots:The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference productApproval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumabIn 2022, Henlius…
September 22, 2025

Read more

Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots:The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference productApproval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumabIn 2022,…
September 3, 2025

Read more

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…
May 28, 2025

Read more

Biogen & Organon
NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots:Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the USAs per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestonesTofidence is a humanized…
April 2, 2025

Read more

VIEWPOINTS_Amy Taneja_2023
VIEWPOINTS

Women Health: Amy Taneja in a Striking Conversation with PharmaShots Shares the Highlights of Jada System

Shots: Amy Taneja, in a stimulating conversation with PharmaShots, shares the highlights of the Jada system, a vacuum-induced hemorrhage control device  Amy describes how the Jada system differs from traditional methods of controlling PPH while explaining how the system works  JADA, which is now being shipped to Chile, Hong Kong, Puerto Rico, New Zealand, and…
December 26, 2023

Read more

Insights+ Key Biosimilars Events of August 2023
INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 patientsDuring the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…
September 6, 2023

Read more

Insights+ Key Biosimilars Events of July 2023
INSIGHTS+

Insights+ Key Biosimilars Events of July 2023

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars 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 the patientsDuring the month of July, Samsung Bioepis reported P-III equivalence study…
August 4, 2023

Read more

Load more