Shuchi Nahar's Weekend Blog!

Biocon Ltd. - Company Overview Twitter Handle: @shuchi_nahar Company Profile Biocon Limited is an Indian biopharmaceutical company based in Bangalore, India established as a joint venture between Ms. Kiran Mazumdar-Shaw and Biocon Biochemicals Limited, an Ireland based multinational. The Company manufactures generic active pharmaceutical ingredients (APIs) that are sold in over 120 countries across the globe, including the developed markets of the United States and Europe. It also manufactures novel biologics, as well as, biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold in both bulk and formulation forms in several emerging markets. In research services, Syngene International Limited (Syngene), a publicly listed subsidiary of Biocon, is engaged in the business of integrated endto-end drug discovery and development services. Biocon’s business is organized into the following reporting segments: · Sm...

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 exam...