DUBLIN, Mar. 27, 2014
/PRNewswire/ --Research and Markets (http://www.researchandmarkets.com/research/3clltz/global) has announced the addition of the "Global Pharmaceutical and Biotechnology Outlook 2014 - India Pharma" report to their offering.
Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2014-16 and later for Developed countries. Though small it is the beginning of NCE/mAb development by Indian companies and is a sign of Indian Generics moving up in the chain.
The uncertainty of clinical and regulatory pathways in the US helps Asian biopharma and biotech companies to be in the forefront at developing and marketing biosimilars. Biopharma/ biotech companies in India, S. Korea, China may have significant advantages of low-cost manufacturing, colossal markets, and healthy government support over potential peers from other regions. The cost barriers in the biosimilar market lead regulated marketed giants to join with Asian companies to gain access to these advantages and hedging their bets through a joint-venture strategy.
Though reimbursement remains a concern as no countries provide full reimbursement - patients pay total cost out-of-pocket in India; with well-defined regulatory pathways, the authors believe Indian biopharma companies keep leveraging their strength of low cost manufacturing along with skilled workforce which would support them to gain global recognition.
Factories in India continue to have the lion's share of the US Generics market, despite a couple of plants at India facing scrutiny from US FDA. India has 526 USFDA units in which 403 intimations of violation (Form 483) of its manufacturing norms to Indian plants in the period from 2011 to Nov 2013. It is to be noted that one fourth of FDA inspection outside the US were conducted in India. But Indian plants have received very less Import alerts/Warning letters by FDA which indicates a strong quality consciousness on the part of Indian Drug Manufacturers.
- Biocon, Cipla
- Cadila Healthcare
- Dr. Reddys
- Panacea Biotech
- Shasun Parma
- Shilpa Medicare
- Sun Pharma
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SOURCE Research and Markets