Cumulative updating of approved biopharmaceuticals

The Company plans to submit a rolling NDA under section 505(b)(2) to the FDA for aldoxorubicin as a treatment for STS.

Disclaimer: The views expressed are those of the authors and do not necessarily represent the views or policies of the US EPA.The 2016/2017 edition is also offered in electronic format for individual users, small groups, business units, or company-wide access.uses cookies to improve performance by remembering your session ID when you navigate from page to page.Proteins are catalysers of metabolic reactions, structural components of biological assemblies, and responsible for inter and intracellular interactions and cell signalling events that are critical for life.All agencies have issued varying guidances for the approval of recombinant biosimilars of biopharmaceuticals, and all submittals are considered on a case-by-case basis.