Tagged as: FDA

FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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FDA Approves Hospira's Epoetin Alfa Biosimilar (UPDATED)

For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product.  Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV…

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FDA Releases Five-Year Plans for User Fee Programs

Pursuant to the five year reauthorization of FDA’s user fee programs for prescription drugs, generic drugs, and biosimilars, FDA recently released its five-year financial plans (2018-2022) for the programs. The plans “communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017 (BsUFA II), the Generic Drug User…

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Commissioner Gottlieb Addresses Biosimilars at Conference

At CNBC’s Healthy Returns conference last week, FDA commissioner Scott Gottlieb discussed plans to encourage competition and speed approval of biosimilars.  His comments largely tracked a statement that he made in early March. Gottlieb again criticized arrangements between distributors, pharmacy benefit managers, and health plans, which he views as restricting market access. …

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Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…

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