Tools of the Trade: How Intrafusion by McKesson Improves …
WEBAug 21, 2022 · Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars.
FDA Approves Adalimumab Biosimilar, Samsung Bioepis' Hadlima
WEBJul 24, 2019 · The FDA on Tuesday approved Samsung Bioepis’ Hadlima (adalimumab-bwwd), referencing Humira. Hadlima, a subcutaneous injection, was cleared for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. "With the approval of Hadlima, we are ...
Teva Announces US Launch of Lenalidomide, Generic of Revlimid
WEBMar 8, 2022 · Teva Pharmaceuticals on Monday launched lenalidomide capsules, the generic of Revlimid, in the United States. The capsules are available in 5 mg, 10 mg, 15 mg, and 25 mg strengths, according to a statement from the company. Lenalidomide is used in regimens to treat multiple myeloma, mantle cell lymphoma, and …
FDA Releases Draft Guidance on Insulin Biosimilars, …
WEBNov 25, 2019 · Article. The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products ...
FDA Approves Pfizer's Adalimumab Biosimilar, Abrilada
WEBNov 16, 2019 · The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira. In a statement, Sarah Yim, MD, acting director of the FDA’s Office of Therapeutic Biologics and Biosimilars in the Center for Drug Evaluation and Research, said she is pleased to see the 25th biosimilar approved in …
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 ...
Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in …
WEBDec 7, 2016 · Although filgrastim-sndz (Zarxio ®) was launched for use as a supportive care treatment about 1 year ago, the pegylated version (pegfilgrastim) Neulasta ® is, by far, the more commonly prescribed agent. This agent has a significantly longer half-life than its predecessor and is the preferred agent in patients receiving cancer chemotherapy.
FDA Approves First Biosimilar for Neulasta Onpro - Center for …
WEBJan 15, 2024 · Coherus Biosciences has announced that the FDA has approved its on-body injector version of Udenyca (pegfilgrastim-cbqv) as biosimilar to Neulasta Onpro (pegfilgrastim with on-body injector). “Our market studies showed a significant demand for a novel on-body pegfilgrastim delivery device tailored to specific patient needs.
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 …
Bio-Thera Moves Golimumab Candidate Into Phase 3 Trial
WEBJun 8, 2021 · Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi. Guangzhou, China–based Bio-Thera Solutions has initiated a phase 3 clinical study for its golimumab biosimilar candidate (BAT2506) referencing Simponi. The double-blind, randomized, parallel, control study will compare the efficacy and safety of ...