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Insights+ Key Biosimilars Events of May 2024

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…

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Teva and Alvotech

Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications 

Shots: The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US The approval was based…

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Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Shots: 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 market The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally Following commercialization collaboration between…

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Alvotech and Teva’s Simlandi (Biosimilar, Humira) Receives the US FDA’s Approval for the Treatment of Multiple Indications 

Shots: 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 Disease 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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