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Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US
Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…
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The US FDA has granted 510(k) clearance to Adaptive Nomogram algorithm in the Aurora Xi Plasmapheresis System to improve plasma collection efficiency
Clearance was based on a trial of Adaptive Nomogram in Aurora Xi Software Version 2.0 vs the existing Optimized Nomogram involving >52,400 procedures that met its 1EP, depicting increased plasma volume…
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The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US,…
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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
The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
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The company has introduced SC formulation of Tyenne, a biosimilar of Actemra, to treat chronic autoimmune diseases across the US. It is available in the form of prefilled syringe & an autoinjector
The IV formulation of the biosimilar was introduced in Apr 2024 after the US FDA’s approval on Mar 05, 2024
Tyenne, an…
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The US FDA approved Fresenius’ Tyenne (tocilizumab-aazg) developed as a biosimilar version of Actemra (tocilizumab)
According to the patent settlement agreement signed between Fresenius Kabi and Genentech for Tyenne, Fresenius has the license to market its tocilizumab products across the US as per the undisclosed licensing dates
Tyenne functions as an Interleukin-6 (IL-6) receptor…
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 September, Sandoz entered into a development and commercialization agreement…
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…
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 the patients
During the month of July, Samsung Bioepis reported P-III equivalence study…
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 the patients
During the month of February, Alvotech entered into a commercialization agreement…

