What do you understand by biosimilar? How are they different from generics? It is said that the market for biosimilar is an attractive one for Indian companies. Examine why.
Biosimilar are equivalent of drugs where the active ingredient is made by an engineered organism e.g. E.coli has been engineered to express a modified version of human insulin gene.
Difference between biosimilar and generics-
- Biosimilar involve developing equivalent of biological entity while generics involve developing equivalent of a chemical entity-the Active Pharmaceutical Ingredient (API)
- Biosimilar are extracted from natural sources while generics through chemical synthesis.
- In case of biosimilar, biological entities being different (and not replica), every organism has to be engineered to produce the same therapeutic effect while in generics, the copies of API can be generated
- Differences in efficiency in biosimilar may arise because of first input i.e. the organism, while in case of generics because the input (API) is same, the differences in efficiency arise because of the process involved.
- Regulatory procedure to get approval for biosimilar is complex as compared to that of a generics
Market for biosimilar is attractive for Indian companies because-
- Huge market exists in EU, Japan and USA. USA FDA has approved two biosimilar drugs in 2016.
- Blockbuster drugs are going to get off-patent soon and hence their manufacturing can be done in India by Indian companies.
- Drugs and Cosmetics Act has been amended to ease down the procedure of clinical trials
- Research in biosimilar can benefit from the Healthcare Mission launched under National Biotechnology Development Strategy (2015-2020)