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Accord Healthcare
NEWS

Accord Healthcare Reports the CHMP’s Positive Opinion on Osvyrti and Jubereq (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025 Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…
April 3, 2025

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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 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…
April 2, 2025

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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Adds into the Costco Member Prescription Program 

Shots:  Celltrion announced that Steqeyma (ustekinumab-stba), a biosimilar to Stelara, has been added to the Costco Member Prescription Program. It was launched on Mar 12, 2025. Celltrion's adalimumab-aaty was added to the program in Aug 2024   Steqeyma will be available in the US from Costco Specialty Pharmacies on Apr 1, 2025, for self-funded employer plans,…
March 28, 2025

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Bio-Thera and Dr. Reddy's
NEWS

Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 (Biosimilar, Stelara) & BAT2506 (Biosimilar, Simponi) Across the Southeast Asia 

  Shots:  Bio-Thera and Dr. Reddy’s have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) & BAT2206, a biosimilar version of Stelara (ustekinumab)  As per the agreement, Bio-Thera will handle the development, manufacturing, and supply of BAT2206 & BAT2506, while Dr. Reddy’s will manage regulatory approvals &…
March 28, 2025

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Fresenius Kabi
NEWS

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
March 27, 2025

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Alvotech, Kashiv Biosciences & Advanz Pharma
NEWS

Alvotech, Kashiv Biosciences and Advanz Pharma Report the MHRA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Shots: The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…
March 26, 2025

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Alvotech and Xbrane
NEWS

Xbrane Entered into an Agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) and Parts of its Organization for ~$27.25M 

Shots:  Xbrane has signed an agreement with Alvotech to sell XB003 (Biosimilar, Cimzia) including related IP and parts of its organization, including 40 employees & laboratory equipment at ~$27.25M (~SEK 275M). The transaction closing is subject to approval from Xbrane's shareholders at the EGM on Apr 14, 2025, and FDI approval.   Xbrane will receive SEK…
March 21, 2025

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Alvotech and Dr. Reddy's
NEWS

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva) 

Shots:  The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product  As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …
March 18, 2025

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