European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Andrew Storaska
To learn about Mr. Storaska's practice, please visit http://www.rfem.com/professionals/storaskaa.
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Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s...
Tagged with: adalimumab, Avastin®, bevacizumab, Enbrel®, etanercept, European Commission, Herceptin®, Humira®, Infliximab, Neulasta®, pegfilgrastim, Remicade®, Rituxan®, Rituximab, trastuzumab
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By Aydin Harston and Andrew Storaska
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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On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s...