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Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US marketÂ
The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globallyÂ
Following commercialization collaboration between…
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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…
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The US FDA has approved Simlandi injection for treating adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa & uveitis as well as juvenile idiopathic arthritis & Crohn's DiseaseÂ
The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in…
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The (AVT03-GL-P01) study assessing safety, PK and tolerability of AVT03 (denosumab) vs Prolia in healthy adult individuals met the 1EPsÂ
The confirmatory study of AVT03 in patients and a trial to evaluate PK of AVT03 vs Xgeva in healthy adult individuals is ongoingÂ
AVT03, a mAb, targets RANK ligand to reduce the numbers…
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Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway
The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…
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…
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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, Samsung Bioepis presented results of SB12…
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The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B
The second quarter of the year also showcases multiple approvals of the therapies…
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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 May, Celltrion’s Yuflyma (biosimilar, adalimumab) received the…
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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 April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

