India is one of the biggest sources of generic industry and is one of the emerging markets with its high population and investment in technology. Although India does not have stringent regulations, the country has a big potential for biosimilars…
If we have a look at the sales figures of Indian biosimilars, 200 million US dollars of sales was recorded in 2008. But according to the analysts, the market will grow to 580 mUSD in 2012, which means a CAGR +30%.
REGISTRATION OF BIOSIMILARS
As described, India is a semi-regulated market and no phase I/II studies are required for biosimilars. To conduct a phase III study is a mandatory step and minimum 100 patients are needed for this study.
Due to the legislation and the environment in the country, the development of a biosimilar can be between 10-20 mUSD in India, much cheaper than the fully regulated countries. And with this regard, the price of a biosimilar, can be 25-40% cheaper than the originator.
Although none of the products can be considered as “true biosimilars“, there are more than 40 biosimilar products in Indian market. 15 epoetin, 8 G-CSF and 4 insulin so-called “biosimilars” are on the market and more than 10 companies are competing in this area.
Reditux, the world’s first biosimilar monoclonal antibody is a special initiative; it is registered as a copy version of Mabthera/Rituxan in India.
The anti CD20 monoclonal antibody was developed by Dr.Reddy’s and is launched with a price of approximately 50% less than the originator. Both Mabthera and Reditux have the same indications; they are used for certain lympohomas, leukemias and rheumatoid arthritis and after the launch of Reditux, the company seeked for approvals in other semi-regulated countries like Peru.
Dr.Reddy’s, the biggest biosimilars player in the Indian market, has several other biosimilars some of which are already approved and on the market:
|Product name||Original product||Originator company||Comments|
|Grafeel (filgrastim)||Neupogen||Amgen||Approved in 2001 and sold in 7 countries|
|Approved in 2007, sold in 7 countries and seeking approval in several others|
|Aranesp||Amgen||Launched in 2010 and the only darbepoetin alfa in India|
|Peg-grafeel (pelfilgrastim)||Neulasta||Amgen||Launched in 2011 and is the only single source pegfilgrastim in the world|
Reference: Sandhu G., Biosimilars: A strategic approach towards development and production requirements ; Generics and Biosimilars Strategies EMEA Conference; 2011 Sept 28; Istanbul, Turkey.