Shuchi Nahar's Weekend Blog!

Biosimilars - The upcoming trend in Pharmaceutical Sector Twitter Handle: @shuchi_nahar 1. What are the trends impacting the global pharmaceutical sector? 2. How are Biosimilars different from Small Molecules? Figure 1: Comparison of Small Molecule and Biosimilars Figure 2: Molecule Size - Small Molecules to Biologics 3 . Procedure for Biosimilar US FDA Approval  Biologics contain active substances derived from living cells or organisms, the development of a biosimilar is much more complex than the process for developing a generic drug. A biosimilar requires the creation of a new manufacturing process and a custom cell line since the reference product’s manufacturing process is proprietary and not publicly available.  Due to the complex nature and production methods of biologics, relatively minor changes in manufacturing processes may significantly affect product quality, safety, and the criteria by which similarity is determined. *Below (Figure 3) is just an illustrative example for t