What are Biosimilars?

Biosimilars are three-dimensional versions of biological products that share an identical protein sequence and common amino acid sequence with the originals (biological drugs) and have demonstrated a high degree of similarity in physicochemical characteristics, efficacy, safety (including immunogenicity) and quality, but with differences in their manufacturing process in the structure of the active protein. However, these biological medicines offer lower-cost alternatives to the original drugs.

The Indian Biosimilar market is poised for big growth, augured by the launch of new products, growing acceptance of biosimilars and the entry of new players like Aurobindo Pharma. It is expected to increase from $186 million in 2016 to $1.1 billion in 2020, according to industry estimates. Indian life science firms are investing in biosimilar development to tap this growing opportunity. They are also establishing manufacturing facilities in other countries to serve the local and export markets. Several of them are opting for acquisitions and alliances to get biologics skills and the latest manufacturing technologies to be able to succeed in the complex regulatory environment.”

 “Biocon and Mylan get USFDA approval to jointly develop biologic product

US health regulator USFDA has accepted pharma major Mylan’s biologics licence application (BLA) for MYL-1401H, a proposed Biosimilar Pegfilgrastim, Biocon and Mylan have said. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement.”


  1. The Indian Biosimilar market is a big opportunity for Latin American countries like Argentina and Brazil and other international countries. Above recent approval of USFDA to Mylan and Biocon is a positive approach towards the opportunities of Indian developed Biosimilar market in world.
  2. As quality requirements and the cost of compliance continue to increase globally, Latin America and other emerging markets will continue to be in focus for Indian industry.
  3. API and Intermediate manufacturers and sourcing companies continue to seek ways to decrease costs and capitalize on these rapidly growing markets.
  4. Indian market players are looking to expand their footprint and established players in Latin America will benefit from emerging companies seeking to further develop their manufacturing and expertise in this growing region.


  1. Article (PDF Available) in Research Journal of Pharmaceutical, Biological and Chemical Sciences 7(5):1794-1809· January 2016
  2. Rushvi P1, Charmy K1*, Nirav C2 and Narendra C2 1Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Ahmedabad, India
  1. http://www.business-standard.com/search?type=news&q=Biosimilars
  1. First post: Wednesday, February 22, 2017

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Author: Vinita Bhandari