UPCOMING BIOSIMILARS OPPORTUNITIES
Issue of drug pricing seems no more restricted to only poor or developing countries. Even in supposedly rich and developed counties like US, it appears to be assuming a lot of importance. Ensuring the accessibility of medicines can be a cost-effective way of treating sickness, as medicine is the most essential component of health care. But one of the important components of accessibility is affordability or price, which needs to be taken care of by the policy makers since affordability and accessibility are directly proportional.
It is disturbing to learn that according to ‘The Commonwealth Fund’ study in 2014, 35 million Americans could not afford prescription medicines. American Heart Association estimates that failure to take a prescribed medicines or reducing its dosage costs $ 300 billion extra in medical expenses and contributes 125,000 deaths a year. The reason being that medicines sold in Canada are 55% less costly than US, points out Web. Reuter’s analysis says prices of top 20 selling medicines are on an average triple than in Britain. As a result, 5 million Americans bought their medicines from other countries in 2013 to save money. Kaiser Family Foundation poll of November 2016 found out that 19 million Americans import medicines from Canada or other countries.
That shows Americans are feeling the pinch. India, Europe and many other countries are either pursuing or trying to pursue the policies to control drug prices. US feels like following them if one reads the recent speech of Scott Gottlieb, USFDA Head.
He announced in Healthy Returns conference that USFDA is working on over a dozen policies to promote use of cheaper versions of costly biotech medicines. The new policies will be in direction to create more avenues for biosimilar competition. USFDA has given priority to approving generic drugs by passing over 1,000 generic drugs in a year. It has approved nine biosimilar therapies. But only three of them have reached the market and six others have been caught into legal issues as they have been challenged by drugmakers to protect their own medicines.
Besides, The Alliance for Health Policy in its briefing session in July 2017 on drug affordability and innovation had considered improving access to generics and biosimilars as one of the initiatives for the purpose. One hindrance in the process is permission given to drugmakers to pay generic manufacturer to delay introducing generic called ‘pay for delay’.
In spite of such obstacles, will the biopharma sector in Asia be able to take advantage of the USFDA announcement of creating more avenues for biosimilar competition is the key issue. It had happened in case of generics. The global generics market had grown to account for 38% of global pharma spending when US adopted regulation favouring generics in 1984, a LEK consulting report said. It added that Asia has led in generics adoption with approximately 40% of global generics spending coming from this region. Being a generics driven area, the APAC region is expected to provide good opportunity for biosimilars. As claimed by the APAC bioimilars market forecast report, many Asians companies have biosimilars molecules under development. Over 300 biosimilars are under development in the Asia region. Within Asia, India appears to be in a good position to take advantage of the situation since it has over 50 biosimilar products as against 16 in Europe and only two in US. Indian companies are reportedly making significant investments in biosimilars development.
Asian companies will have to adopt various steps to enter into US biosimilar market at a large scale. Understanding the regulatory processes and maintaining quality are two key steps. With all such issues and actions, will Asian pharma companies be able to follow the generics pattern is to be seen. Experts are of the opinion that they will. If they do, then it will open up huge opportunities for Asian companies in biosimilars.