The end of August felt like back-to-school season for the biopharma industry as the regulatory quiet of the past few weeks was broken by filings and approvals.
FDA's Center for Drug Evaluation and Research approved its third 351(k) application, clearing Sandoz Inc.'s biosimilar version of Amgen Inc.'s anti-tumor necrosis factor (TNF) biologic Enbrel, known as Erelzi (etanercept-szzs)
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