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 Celltrion and Teva's Trastuzumab Biosimilar, Herzuma
WEBDec 15, 2018 — The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer. “Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy,” said Woosung Kee, CEO of Celltrion, in a statement announcing the ...
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 ...
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 …
EirGenix Trastuzumab Biosimilar Candidate Demonstrates …
WEBDec 8, 2021 — Trastuzumab is a standard therapy for HER2-positive breast cancer, and the investigators said the addition of trastuzumab to neoadjuvant treatment involving anthracyclines and taxane-based therapy has improved pathologic complete response (pCR), event-free survival (EFS), and overall survival (OS). In …
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 …
Amgen 2020 Biosimilar Report Provides Market Share, ASP Info
WEBOct 14, 2020 — Retacrit now has a 25% share of the market for epoetin alpha vs 18% for Procrit and 57% for Epogen. In the US infliximab market, 3 biosimilars have been marketed, including Avsola (July 2020). The ASP for reference Remicade has dropped to 33% below its pre-biosimilar cost, and the ASPs for Renflexis and Inflectra currently stand at …
First Dornase Alfa Biosimilar Approved and Launched in Russia
WEBSeptember 21, 2019. By The Center for Biosimilars Staff. Article. This week, Russian drug maker Generium announced that it has received approval for—and has launched—its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.
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 Releases Guidance on Biologic, Biosimilar, and …
WEBMar 7, 2019 — The FDA no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, according to an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. However, the new guidance explains that the agency will continue to assign suffixes to newly approved innovator biologics ...
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