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®
WEBSarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 · The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
Novo Nordisk Launches Authorized Generic Insulins, Gets FDA …
WEBJan 7, 2020 · Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.
FDA Approves Pfizer's Rituximab Biosimilar, Ruxience
WEBJul 23, 2019 · This article has been updated. The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. The fact that …
Amgen Discusses Interchangeable Status for Its Adalimumab …
WEBNov 8, 2021 · The company said it has a trial under way to help qualify Amjevita for interchangeable status, which would allow pharmacists to substitute the product for reference brands. The product brought in $111 million in revenues in the quarter just ended, up from $80 million a year earlier. Biosimilars contributed to …
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 …
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 ...
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 …
FDA Approves Idacio, the Eighth Adalimumab Biosimilar
WEBDec 14, 2022 · Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.. In January 2023, 1 adalimumab biosimilar (Amgevita) will launch on the US market, followed by up to 9 others, including Idacio, in July 2023.Upon launch, Idacio will be offered in a citrate-free ...