Definition: Biosimilars are biopharmaceutical drugs which are designed to have active properties similar to drugs that have previously been licensed. Indian guidelines have defined it as
“A biological product or drug produced by genetic engineering techniques and claimed to be “similar” in terms of safety, efficacy and quality to a reference biologics, which has been authorized by Drug Controller General of India (DCGI) for safe use in India.”
Market Value:
Indian biologics market crossed us $3 billion in 2011-2012 when compared to global sales of biologics US $157 billions in 2102. And this is obviously a good number keeping the socio-economic aspect, literacy level, etc in mind.
But, still a question keeps lingering in the minds of all- Is there any scope of growth of biosimilars in country like India keeping in consideration about the various socio-economic aspects of the country?
Why?
Yes, there is a tremendous growth for biosimilars in this third-world country. It even has got the potential to be on the top of the world. But what makes it emerge as a black horse?
Well, there are many qualities that attribute to the success of India in the global market. Some of them include:
- Illiteracy
- Change
- Advancement of Science
- Cost of biosimilars
- Less Entry of Competitors
- Government initiatives to encourage Biosimilars
- Literacy Rate:
India’s literacy rate is at 74.04% according to the 2011 census when compared to the 53.67% in 2001 census. So, this is definitely an honor for the country. Increased literacy is directly proportional to the increased awareness (regarding latest innovations) among the citizens.
Therefore, there is a scope of growth for biosimilars in the Indian market.
Increasing Literacy ∝ Increasing awareness among the beings
- Change:
Being a literate brings countless change in people. As a person starts reading/getting aware of novel things, he starts embracing change.
So, augmented literacy rates bring about a huge change in the thought process which ultimately leads acceptance of new things including biosimilars.
- Advancement of Science:
Advancement of science on a day-to-day basis is one of the strongest reasons for the growth of biosimilars in the distrustful/reluctant/rigid Indian market. The development pattern in the science and technology sector is making many people actually approve new innovations.
And this definitely is a very good sign for India.
- Cost of biosimilars:
Cost again is one of the staunch reasons for the tremendous growth of biosimilars in the Indian market. Biosimilars for a matter of fact are expected to save a lot of billions of money.
So, the less cost means many people can actually afford to buy the product devoid of any reluctance.
Less cost = Increasing acceptance of biosimilars among the beings
- Less Entry of Competitors:
Though still not a boom, there are actually very less number of competitors in the Indian biosimilar market. Fewer competitors would mean a excellent growth of biosimilar in the Indian market.
News: On 27th June, 2014, Hyderabad-based Hetero Drugs announced the launch of a biosimilar, named Bevacizumab for the treatment of colorectal cancer. The drug is estimated to have a potential market of close to Rs 180 Crore.
- Government initiatives to encourage Biosimilars:
In a third-world country like India, government initiatives actually are of a very strong point to many people (especially rural India). The Government of India (GOI) kind of becomes an opinion leader over here.
India’s Central Drugs Standard Control Organization (CDSCO) released revised guidelines for the approval of biosimilars in March, 2016.
Many Indian companies like Biocon, Dr Reddy’s, Zydus Cadila, Wockhardt, Intas, etc are heretofore active in biosimilar markets in India and as well as emerging markets.
