European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Regulatory
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By C. Nichole Gifford Comments are off
Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
Tagged with: Allergan, Amgen, Biocon, Celltrion, FDA, Genentech, Herceptin®, Hospira, Mylan, News, Pfizer, Regulatory, Teva, trastuzumab
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By Aydin Harston Comments are off
The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By C. Nichole Gifford Comments are off
Novartis’ First CAR-T Cell Therapy Tisagenlecleucel (CTL019) The FDA’s Oncologic Drug Advisory Committee (“ODAC”) held a public...
Tagged with: Allergan, Amgen, Avastin®, bevacizumab, Biocon, CAR-T, FDA, Genentech, Herceptin®, Mylan, News, Novartis, Regulatory, Roche, Tisagenlecleucel, trastuzumab
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By Aydin Harston and Andrew Storaska Comments are off
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By C. Nichole Gifford Comments are off
Celltrion announced last week that its Biologics License Application (“BLA”) for CT-P10, a biosimilar to Biogen and Genentech’s...
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By Andrew Storaska Comments are off
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s...
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By C. Nichole Gifford Comments are off
We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory
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By Aydin Harston Comments are off
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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