4 天之前 · Patients with psoriasis who switched from reference ustekinumab to its biosimilar, SB17, experienced comparable long-term efficacy and safety, alleviating concerns about switching and promoting wider use of more affordable treatment options, according to a study published in the Journal of Dermatological Treatment. 1. Biologic treatments have improved efficacy and revolutionized the treatment ...

2024年12月18日 · The approval represents the seventh biosimilar approval for a Stelara competitor. 2 Steqeyma follows Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce), the last of which was approved at the beginning of December 2024. 3 ...

2024年12月11日 · Sandoz's biosimilar denosumab (Jubbonti/Wyost; denosumab-bddz) has demonstrated analytical, pharmacokinetic (PK), pharmacodynamic (PD), and clinical equivalence to the reference denosumab (Prolia/Xgeva), justifying its approval and extrapolation to all indications, according to a study published in Clinical Therapeutics. 1. The narrative review summarized the totality of evidence for denosumab ...

2024年10月11日 · Stelara is one of the highest-grossing biologics in the US, generating $10.86 billion globally in 2023. Additionally, US sales for Stelara reached $6.4 billion in 2022, according to Johnson & Johnson's annual financial report.It’s also 1 of the first 10 medications selected by CMS for drug price negotiation, which will go into effect at the start of 2026.

2024年3月5日 · The FDA has approved Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US. 1 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.. The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in February 2023.

2024年12月25日 · In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.

2024年11月6日 · Currently, Celltrion USA has 6 biosimilars (infliximab, rituximab, trastuzumab, adalimumab, bevacizumab, on the US market, as well as Zymfentra, a novel product that allows for the subcutaneous administration of its infliximab biosimilar (Inflectra, Remsima).

2024年11月11日 · Patent litigation is often resource intensive on both sides. During an interview with The Center for Biosimilars, Ha Kung Wong, JD, an intellectual property attorney and partner at Venable, noted that the patent dance has been instrumental in promoting settlements, reducing the need for many cases to proceed to trial. 2 “The patent dance allows for an early assessment of infringement and ...

2024年12月16日 · Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to …

2024年12月2日 · The biosimilar was developed by Karnataka, India–based Biocon Biologics and will likely launch in the second half of 2025, along with Otulfi (ustekinumab-aauz), Selarsdi (ustekinumab-aekn), Imuldosa (ustekinumab-srlf), and Pyzchiva (ustekinumab-ttwe).