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 US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…

ByRidhi RastogiApril 2, 2025

News

Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

Shots: The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total…

ByRidhi RastogiMarch 28, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Third Quarter 2024

Shots: The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity Our…

BySaurabh ChaubeyOctober 1, 2024

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…

BySaurabh ChaubeyDecember 26, 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 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 August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…

BySenior EditorSeptember 6, 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 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 the patients During the month of July, Samsung Bioepis reported P-III equivalence study…

BySenior EditorAugust 4, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of January 2023

Shots: 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 the patients During the month of January, Celltrion reported P-III trial results of…

BySenior EditorFebruary 1, 2023

INSIGHTS+

Insights+ Key Biosimilars Events of November 2022

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 the patients During the month of November, Samsung Bioepis presented two P-III studies results…

BySenior EditorDecember 1, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of August 2022

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 the patients During the month of August, Formycon reported P-III (VESPUCCI) trial results of…

BySenior EditorSeptember 1, 2022

INSIGHTS+

Insights+ Key Biosimilars Events of June 2022

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 the patients During the month of June, Organon entered into an agreement with Henlius…

BySenior EditorJuly 7, 2022

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

Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

PharmaShots’ Key Highlights of Third Quarter 2024

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

Insights+ Key Biosimilars Events of August 2023

Insights+ Key Biosimilars Events of July 2023

Insights+ Key Biosimilars Events of January 2023

Insights+ Key Biosimilars Events of November 2022

Insights+ Key Biosimilars Events of August 2022

Insights+ Key Biosimilars Events of June 2022

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