A Critical Analysis of the FDA Draft Guidance on Development of ...
WEBJun 4, 2019 · Introduction. In May 2019, the FDA issued a long-awaited and highly anticipated guidance on establishing analytical testing of biosimilars to a reference product after it withdrew its guidance, Statistical Approaches to Evaluate Analytical Similarity of biosimilars, in June 2018.. The new draft guidance applies to proposed biosimilars and to other protein products, such as in vivo protein ...
An Interchangeable Biosimilars vs Authorized Biologics Battle May …
WEBOct 27, 2021 · Several interchangeable biosimilars and authorized biologics could emerge for the reference insulin aspart product Novolog, Casberg said. Those include MYL-1601D, from Viatris, for which biosimilar approval is anticipated in 2021; SAR341402, a Sanofi potential interchangeable, for which no FDA application has yet been filed; and an “interchangeable” authorized biologic candidate, from Novo ...
FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar
WEBMay 24, 2023 · The FDA approved the biosimilar for 8 indications: Yuflyma is the fifth biosimilar and second anti-tumor necrosis factor biosimilar developed by Celltrion Healthcare to receive FDA approval. Yuflyma is also approved in the European Union and Canada. “Yuflyma offers patients a high-concentration and citrate-free formulation of …
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.
Canada Approves High-Concentration Humira Biosimilar
WEBJan 3, 2023 · Samsung Bioepis announced the Canadian approval of its high-concentration (HC), citrate-free formulation of its biosimilar referencing Humira (adalimumab). Hadlima HC was developed through a commercialization agreement between Samsung Bioepis and Organon. The approval comes almost 4 years after Health Canada’s initial approval of the low-concentration version of Hadlima (SB5) in May 2018.
Rezvoglar Becomes Second Interchangeable Insulin Biosimilar
WEBNov 23, 2022 · The FDA approved for Rezvoglar (insulin glargine-aglr), a biosimilar for Lantus (insulin glargine) that was originally approved in December 2021, for an interchangeability designation, allowing the product to be exchanged for the reference product at the pharmacy level without requiring physician permission. “This approval furthers the FDA’s longstanding commitment to support a competitive ...
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 ...
Celltrion Biosimilar Demonstrates Equivalence With Xolair in Phase …
WEBMar 14, 2022 · Presented at: AAAAI 2022; February 25-28, 2022; Phoenix, AZ. Abstract 586. A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.
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 …
Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology
WEBJan 6, 2022 · Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology. Biobetters may gain an edge on reference products, and multiple biosimilars are under development for ophthalmic disorders, the authors write. A strong market and development push for “biobetters” is anticipated by authors of a …