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

India Emerging as a Next Biologic Drug Hub SHUCHI.P.NAHAR The Indian pharmaceutical companies always had strong chemistry skills to work on small molecules to make generic drugs, but they lacked skills, people and ecosystem to work on large molecules to come up with reverse engineered versions of biotech drugs, many experts complain. However, it is beginning to change.   'India: the emerging hub for biologics and biosimilars', the Indian pharmaceutical companies have launched 123 biosimilars and currently have 201 active biosimilars covering multiple indications in the development pipeline. Further, India has 95 approved biosimilars in the domestic market, more than any other country in the world. Biologics are the biological products regulated under the rules of the Food and Drug Administration (FDA). They are used to either diagnose, prevent, treat, or cure various medical conditions.  Significantly, biologics are large, complex, and diverse molecules produced through biotech