Alvotech Expands its Partnership with Advanz Pharma to Commercialize Three Additional Biosimilars in the EU

Shots:Alvotech has entered into an agreement with Advanz Pharma to expand their commercial partnership to include 3 more biosimilar candidatesAs per the deal, Advanz will register & commercialize biosimilars of Ilaris (canakinumab), Kesimpta (ofatumumab), & an undisclosed biologic in the EU, while Alvotech will handle development & commercial supply; partners will share revenues,…

ByRidhi Rastogi1 day ago

News

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots:The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved presentations: 45mg/0.5mL & 90mg/mL…

ByRidhi RastogiMay 6, 2025

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 & CRSwNPAlvotech & 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 &…

ByRidhi RastogiMarch 26, 2025

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…

ByDipanshu DixitMarch 21, 2025

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. …

ByDipanshu DixitMarch 18, 2025

News

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Shots:Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr…

ByRidhi RastogiFebruary 24, 2025

News

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots:The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

ByRidhi RastogiFebruary 20, 2025

News

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots:The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

INSIGHTS+

Insights+ Key Biosimilars Events of May 2024

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 patients   During May, Teva & Alvotech launched Simlandi injection Treat Multiple Indications. Our…

ByDipanshu DixitJune 4, 2024

INSIGHTS+

Insights+ Key Biosimilars Events of February 2024

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 patients During February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics…

BySenior EditorMarch 4, 2024

Alvotech Expands its Partnership with Advanz Pharma to Commercialize Three Additional Biosimilars in the EU

Teva and Alvotech’s Selarsdi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

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

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

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

Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Insights+ Key Biosimilars Events of May 2024

Insights+ Key Biosimilars Events of February 2024

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