Bangalore, Feb 04, 2010: Biopharmaceuticals continue to outperform the pharmaceutical market with the US alone predicted to touch a figure of about $60 billion by 2010. The latest agenda for many companies now is to utilize the opportunities in biosimilar market.
In a short term, biosimilar market growth will be driven by drug classes including erythropoietin, filgrastim, human growth hormone (HGH) and insulin. Gradual expiry of patents will create significant market opportunities for developers through to 2016. Between 2012-19, the market will see a patent expiry of a whopping $60 billion of biotech drugs.
Indian scenario
In India biosimilars spell big opportunities especially for companies like Dr Reddy’s Labs, Ranbaxy, Biocon, Shantha Biotech and Intas Biopharmaceuticals, who are actively involved in the space. The Indian biosimilars market in 2008 was about $200 million, with an expectation to reach about $580 million by 2012.
Mr Jay Desai, Founder and CEO, Universal Consulting, says, “In India, the interest in biosimilars is additionally spurred on by multiple factors. Firstly, under the Trade Related Intellectual Property Rights (TRIPS) agreement, pre-1995 product patents were exempted thus granting some biologicals, the rights to continue manufacturing.
Secondly, biotechnology drugs (besides insulin) are free from the government’s price control act, allowing independence in price setting. There seem to be signs of acceptance of locally manufactured biosimilars among healthcare professionals within the country.”
The upcoming oncology market is one of the prime targeted areas for many companies. The current size of the Indian oncology market is about $18.60 million, which is expected to be over about $50 million by the end of 2010.
According to estimates, in India, EPO has clocked a sales of about $22 million, c-GSF has sales of about $11 million, interferon has a sales ofabout $22 million, streptokinase has sales of about $16 million, and insulin has a sales of about $55 million.
Dr Reddy’s Labs created a niche in the oncology with the launch of its affordable biosimilar product, Reditux, in 2003. Biocon has four products developed in India; viz EPO, insulin, GCSF and streptokinase with its human insulin product being sold in the market at a discount of almost up to 80-85 percent. Glenmark is planning to come out with its first biotech product by 2010 from its biological research establishment located in Switzerland. Similarly, Ranbaxy with its strategic collaboration with Zenotech Laboratories is planning to market G-CSF oncology products in various markets of the world like Brazil, Mexico, CIS and Russia. Reliance Life Sciences launched three biosimilars—ReliPoietin Erythropoietin (EPO), ReliGrast Granulocyte Colony Stimulating Factor (G-CSF), and ReliFeron (Interferon Alpha 2b) in the domestic market in 2008.
Intas Biopharmaceuticals has launched four biosimilar products—G-CSF, EPO, Interferon Alpha Beta (IFN-) and Peg-GCSF in international as well as domestic markets. Wockhardt has biosimilar products at various stages of development and is targeting the US and EU markets. Cipla has entered into an 50:50 joint venture (JV) with a Chinese company for biosimilars.
The JV called BioMab, expects the first product to be out by 2010. Industry experts fear that the market will see the mushrooming of a number of other players who may compromise quality to make quick
money.
EU, US markets: Not a cakewalk
Attaining a firm grip in the EU and the US markets will not be a cakewalk for India. With EU already out with a pathway in 2006 and the USFDA scheduled to come out with one in another five years, Indian players are investing heavily keeping these two markets in mind. However, industry experts claim that it will be a different ball game altogether. Says Mr Desai, “The current theory-in-use is that India will at some point in the not-too-distant future, replicate the relative success of its pharma generics industry in the biosimilars market worldwide. The theory-in-practice may well turn out to be quite different.”
According to Mr Peter Wittner, Senior Consultant, Interpharm Consultancy, “It will be a bumpy road for India. Registering a biosimilar product in the EU (EMEA) will be easier since the guidelines have already
been laid out, yet the cost of compliance is extremely high. Moreover, in regions like the EU, the entry cost is high leading to low competition and fewer players.”
Need for an independent regulatory body
The call of the hour is to set up an independent regulatory pathway in India for the approval of biosimilar products. At present, the Drug Controller General of India (DCGI) gives the go ahead for market approval both for generic as well as biotech drugs. Without a regulatory body, there might be chances of low-quality products being sold, which in turn can ruin the reputation of the Indian industry.
In 2004, there was a call by a section of the industry for an independent body for approval of biologics. Nothing concrete has come up since then. Dr Patankar, who then represented the Confederation of Indian Industry (CII), recalls “The need to streamline and draft guidelines for biosimilar drugs first came about in 2004 with the setting up of the Mashelkar Task Force which had representatives both from associations and the industry.”
Only a few recommendations from the task force are being implemented today. All eyes are now on the WHO guidelines for biosimilars which can bring about some stability.
Competition from China
There are apprehensions of India facing tough competition from China. Experts are divided in their opinion as to which country has the upper hand. China at present has a number of small players operating in the space. Dragon Pharma alone has 20 GCSF products in the pipeline. “China has the edge over us in terms of manufacturing and expertise and hence they might eat up a major share of the global biosimilar market,” says Dr Arumugam Muruganandam, Senior Scientific Manager, R&D, Biocon. However, experts also believe that India has the edge over China because of a large number of ‘big players’ in India participating in the space which is not yet to be seen in China.
Biobetters: The future
The new turf for biotechs, both innovator and biosimilar companies alike are ‘biobetters’, which are second generation biopharmaceuticals showing improved performance and efficacy over the innovator product by a slight modification of the molecule. There can be two possibilities. The first being a biosimilar company which has a drug target in mind, has the proven clinical results but then induces a slight clinical change in the molecule design which then brings out a product which is better than the innovator product. The second situation is when an existing molecule of an innovator product is modified to bring out a drug which does not exist in the market at all. Industry experts however opine that Indian players should take one step at a time while shifting their focus on biosimilars.
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