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With biosimilars being already commercially marketed in India and with multiple biosimilars in the Indian market for the same blockbuster drug, it is becoming increasingly important to understand the concerns and strategies relating to the developments of biosimilar products.

Manufacturers are increasingly turning to biosimilars because of its almost “similar” accuracy in treating specific diseases which only the originator drugs were capable of curing, making it possible for patients to enjoy cheaper and effective treatments.

India also offers a unique abbreviated regulatory pathway for faster market access that provides post-commercial data on pharmacovigilance, acting as a launch pad for global regulated markets. With patents on originator blockbuster drugs worth US$ 67 billion expiring or close to expiring by 2020, India is expected to account for 20-25 per cent of global biosimilars in next five years, according to a study conducted by BioAsia and KPMG. Frost & Sullivan also reveals that the global biosimilars market earned revenue of about $1.2 billion in 2013 and could reach $24 billion in 2019. According to the Indian Ministry of External Affairs, the global biosimilars sales reached over US$3 billion in 2012 and expected to hit $252 billion by 2017 fast tracking biosimilars development, in which India will play a major role.

Advancements in the development of biopharmaceuticals will not slow down anytime soon, and its growth is expected to overtake that of conventional drugs.

– India: The ultimate biosimilars destination –

The global market for biosimilars is estimated to grow to US$3 billion by 2015 with the impending patent cliff being the key driver for development and collaboration activities across the globe. India has risen from the 15th largest pharmaceutical market in 2007 to 12 in 2011 and is expected to become the 8th largest by 2015. India’s pharmaceutical market has a compound annual growth rate (CAGR) of 12{db8e60a30f8af32d2a49a3f6e0c4ec87ddf9d09ddfa09ec95f45abee0ee91db0} post price controls.

India is definitely one of the global leaders in the biosimilars industry, being the only country in the world to have the largest amount of marketed biosimilar drugs within the country. With support from the government in biopharmaceutical industry growth, government-led initiatives and biotechnology parks in cities like Hyderabad, Bangalore, and Pune, the biosimilars industry is thriving at an exponential growth.

The Department of Biotechnology (Biotechnology Industry Research Assistance Council) is inviting proposals from Indian companies working on biosimilars under its Biotechnology Industry Partnership Programme. The proposal provides opportunities for the development of novel and high-risk futuristic technologies and to enhance existing R & D capacities specifically for biosimilars, on a cost-sharing basis to biotech companies. This governmental partnership with industry aims to nurture R & D and innovation in the biotech industry, thereby reinforcing India’s position as a major player in the biosimilars market. The Drug Controller General of India and the Central rugs Standard Control of India (CDSCO) are making conscious efforts to harmonize the Indian Regulatory guidelines with those of the FDA and EMA guidelines on biosimilars.

Indian manufacturers are already distributing biosimilars in Latin America, ASEAN and Eastern Europe. The expansion into the regulated markets is inevitable and stirred the major Indian biotech players into stargazing and innovating to be the first to enter the regulated markets. Partnering for success is a key agenda on the business plans for these major biotech companies. India’s biosimilars industry is also experiencing a rapid transformation in terms of growing partnerships between established and newer biotech firms. While 2009 heralded the start of India’s biosimilar era with five key alliances, a spate of such collaborations continued in the next three years with 17 alliances in 2010, 12 in 2011 and 15 alliances in 2012. While 30{db8e60a30f8af32d2a49a3f6e0c4ec87ddf9d09ddfa09ec95f45abee0ee91db0} of the alliances were structured as acquisitions, the remainder were collaborative agreements for development, licensing and/or marketing.

With a strategic location, the second largest population in the world, cheap manufacturing, favourable economic climate, strong government support, technological leadership, and a pool of world-class researchers and experts, India is poised to become an important and bright spot on the global biologics map.

Join us in Hyderabad in the most influential Biologics industry gathering in India in February 2019!