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EMA Accepts Marketing Authorization Application For Alvotech's AVT05 (Golimumab)

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FDA Accepts Alvotech and Teva's Biosimilar Application for Golimumab (AVT05)

The FDA has accepted the BLA for AVT05, a biosimilar to Simponi/Simponi Aria (golimumab), marking the first such acceptance in the U.S.
AVT05 is intended for inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

EMA Accepts Marketing Application for Golimumab Biosimilar AVT05

The EMA has accepted Alvotech and Advanz Pharma's application for AVT05, a biosimilar to Johnson & Johnson's Simponi (golimumab), used to treat chronic inflammatory diseases.
AVT05 demonstrated similar safety, efficacy, and immunogenicity to Simponi in a confirmatory clinical study involving patients with moderate to severe rheumatoid arthritis.

EMA Accepts Alvotech and Advanz Pharma's Biosimilar AVT05 Application for Simponi

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for AVT05, a biosimilar to Johnson & Johnson’s Simponi (golimumab).
AVT05 represents the first global MAA filing for a biosimilar candidate targeting Simponi, a biologic drug used in treating chronic inflammatory conditions.

FDA Approves Additional Presentation for Alvotech and Teva's Ustekinumab Biosimilar

The FDA has approved an additional presentation for the ustekinumab biosimilar developed by Alvotech and Teva, expanding its availability to patients.
This approval marks a significant step in providing more accessible and potentially lower-cost treatment options for conditions currently managed with ustekinumab.

EMA Accepts Marketing Application for Alvotech's Golimumab Biosimilar, AVT05

The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application (MAA) for AVT05, a biosimilar candidate to Simponi (golimumab).
AVT05 is intended for the treatment of several chronic inflammatory diseases, potentially offering a more affordable alternative to the reference biologic.

EMA Accepts Alvotech's Biosimilar Golimumab (AVT05) Application for Review

The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT05, a biosimilar to Simponi® (golimumab).
AVT05 is intended for treating chronic inflammatory diseases, marking the first global filing for a golimumab biosimilar.

EMA Accepts Alvotech's Biosimilar Application for Simponi (Golimumab)

The European Medicines Agency (EMA) has accepted Alvotech's marketing authorization application for AVT05, a biosimilar to Simponi (golimumab).
AVT05 is intended for treating chronic inflammatory diseases, potentially expanding treatment options for patients across Europe.

EMA Accepts Marketing Application for Alvotech's Golimumab Biosimilar, AVT05

The European Medicines Agency (EMA) has accepted the Marketing Authorization Application for AVT05, a proposed biosimilar to Simponi® (golimumab), used to treat chronic inflammatory diseases.
AVT05 is the first biosimilar candidate to Simponi® to have a marketing authorization application filed globally, with potential approval expected in Q4 2025.

Teva's Denosumab Biosimilar Candidate Accepted for Review by FDA and EMA

Teva Pharmaceutical's biosimilar candidate for denosumab has been accepted for review by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Denosumab is a key drug used in the treatment of osteoporosis and prevention of skeletal-related events in patients with bone metastases from solid tumors.

EMA Accepts Alvotech's Biosimilar AVT03 for Prolia and Xgeva

The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia and Xgeva.
AVT03 demonstrated clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in clinical studies.

Reference News

[1]
EMA Accepts Marketing Authorization Application For Alvotech's AVT05 (Golimumab)
mondaq.com · Nov 11, 2024

Goodwin's 1,600 lawyers globally excel in complex transactions, litigation, and advisory services across tech, life scie...

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