FDA Approves Biosimilar Enzeevu for Eye Conditions
WEBAug 12, 2024 · Article. The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases. Sandoz secured another approval, this time for an aflibercept biosimilar. 1 Enzeevu (aflibercept-abzv) is the fourth biosimilar referencing Eylea …
Festival of Biologics - Center for Biosimilars
WEBMarch 22nd 2023. At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.
FDA Approves First Subcutaneous Infliximab Product - Center for …
WEBOct 23, 2023 · The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab). The intravenous version of Zymfentra is marketed as Inflectra (also, infliximab-dyyb), Celltrion's ...
Center for Biosimilars®
WEBSeptember 24th 2024. Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.
Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin …
WEBMar 4, 2019 · Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price. The price of insulin has been top-of-mind for many lawmakers from both sides of the aisle, starting with a Senate ...
ESNO Releases Biosimilar Switching Guide for Nurses
WEBJul 5, 2018 · Last week, the European Specialist Nurses Organisations (ESNO) released a document aimed at assisting nurses in the management of switching a patient from a reference biologic to a biosimilar. The guidelines specifically address the role of specialized nurse interactions with patients during the switching process and build upon existing European Commission guidelines for the healthcare community.
FDA Approves First Denosumab Biosimilars - Center for Biosimilars
WEBMar 5, 2024 · 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.
FDA Approves Autoinjector Version of Neulasta Biosimilar
WEBMar 6, 2023 · The original version of Udenyca was approved in November 2018 and launched on the US market in January 2019. It is 1 of 6 FDA-approved biosimilars referencing Amgen’s Neulasta. In addition to the 2 FDA-approved presentations for the biosimilar, another application for an on-body injector version is under review.
Breaking Barriers in Osteoporosis Care: New Denosumab …
WEBJun 16, 2024 · These products were approved in March 2024 and although they are the same drug, the different brand names correspond with different indications: Wyost is used for musculoskeletal issues related to bone metastases and Jubbonti is used for osteoporosis and patients with a high risk of fracture. We have 2 esteemed guests to talk to us about how ...
FDA Approves First Stelara Biosimilar, Wezlana - Center for …
WEBNov 1, 2023 · The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation. Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and …