Posted in:Regulatory Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline By Andrew Storaska and Aydin Harston September 7, 2017 European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of... Read more Tagged with: BPCIA, EMA, FDA, Regulatory
Posted in:Regulatory The Impact of Biosimilars on Global Pharmaceutical Markets By Andrew Storaska August 17, 2017 Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s... Read more Tagged with: adalimumab, Avastin®, bevacizumab, Enbrel®, etanercept, European Commission, Herceptin®, Humira®, Infliximab, Neulasta®, pegfilgrastim, Remicade®, Rituxan®, Rituximab, trastuzumab
Posted in:News Update: BsUFA II Clears the House and Awaits Senate Vote By Aydin Harston and Andrew Storaska July 14, 2017 H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee... Read more Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
Posted in:News Sandoz’s Rixathon® (rituximab) Approved in Europe By Andrew Storaska June 29, 2017 On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s... Read more Tagged with: EMA, FDA, Genentech, Mabthera, News, Regulatory, Rituxan®, Rituximab, Rixathon®, Sandoz