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Innovation holds the key for industry transition

S.V.Krishna Prasad
Thursday, February 6, 2014, 08:00 Hrs  [IST]

The most important points that comes to mind while talking about innovation are shelf life, expiry date and ephemeral nature of an invention. Unless an invention progresses , in other words evolves, it gets redundant and becomes unviable.

Darwin's theory of evolution, which is universally applicable , is quite relevant here. BioAsia 2014's theme reflects the significance of this sequence of innovation and evolution in the biological and life sciences sector.

Evolution of innovation has resulted in the industry moving from generics, new drug discoveries to biologics and bio-similars which are now slated to be the future growth areas in all spheres starting from product identification, research, testings, evident in all streams.

The best example of evolution today is from the ape/cave man up to a person using a computer. Over the past 30 years, the evolution and performance of the biopharmaceutical sector has been remarkable. Combined with related advances in medical practice, new pharmaceuticals and biologics , it has delivered extraordinary economic and health benefits, from drugs that offer proactive treatments against conditions such as hypertension to the development of life-saving drug regimens that combat AIDS and cancer.

Biopharmaceutical innovation has been linked to significant improvements in mortality and clinical outcomes, and offers cost savings and productivity gains over alternative treatments. Moreover, the bio pharmaceutical industry has been a reliable source of high-wage, high-skilled employment, and until the recent past, has generated persistently high returns to investors. Widely regarded as a success story for government support of R&D, this sector has attracted increasing policy- attention as a potential source of regional and national economic development.

Regulatory pathway
Biologics:Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval.

Given the nature of patents on biologics, the period of data exclusivity is anticipated to have a key role in determining how quickly follow-on competitors emerge, and consequently also on the time available for originator companies to recoup their investment. With this issue in mind, this article discusses factors influencing return on investment on biologic research and development. A break-even analysis for a representative portfolio of biologics provides support for a substantial data exclusivity period.

Biosimilars: Patents for several biologic blockbusters will expire in the next few years. The arrival of biosimilars, the biologic equivalent of chemical generics, will have an impact on the current biopharmaceuticals market.

Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market. These are research and development, manufacturing, supporting activities, marketing and lobbying. Understanding the importance of each of these capabilities will be the key to maximising the value generated from the biologics patent cliff.

The cost of monoclonal antibody therapies for cancer is soaring. Healthcare payers and patients are increasingly struggling to meet the high costs. A number of methods have been proposed to control these costs—government price controls on cancer drugs, biosimilars and novel drug pricing strategies. The impact of these strategies would be in terms of their ability to reduce costs and their effect on innovative cancer drug discovery which makes.

With Indian pharma majors such as Dr.Reddys Laboratories in the forefront of these new areas of innovation and in view of the premier event such as BioAsia, highlighting innovation and evolution is never as more appropriate and relevant than in 2014. Dr.Reddy's being one of the core sponsors to this event is a testimony to the fact of such evolution.                

(The author is CEO & Director of Cito Healthcare Pvt Ltd)


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