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 While Indian firms have launched a few such products on the domestic
market, where regulatory barriers are relatively low, they are being
overtaken by European, American and South Korean firms in the race
to supply lucrative Western markets.
Just three Indian groups - Biocon Ltd, Dr Reddy's Laboratories Ltd
and Intas Pharamceuticals Ltd - are working with partners on
so-called biosimilars aimed at the United States and Europe.
Biotech drugs, which require genetic engineering, account for a
growing share of new drugs and the future sales of copycat products
will also switch to this category of pharmaceuticals from simple
small-molecule pills like aspirin.
The global biosimilars market is predicted to have sales of $25
billion by 2020, according to a 2014 Thomson Reuters report.
"Biosimilars is a big opportunity," said Sujay Shetty, leader of the
life sciences practice at PwC India. "But unlike generics, it is not
yet an opportunity (for Indian companies) in the U.S."
Copying chemical-based drugs has long been the bedrock of India's
$15 billion pharmaceuticals industry. Biotech drugs, however, are
more difficult to make and cannot be replicated exactly, which is
why regulators have come up with the notion of versions that are
similar enough to do the job.
That also means regulators will be eagle-eyed on quality, posing a
challenge to Indian companies, which have been distracted in recent
years by manufacturing problems that have led to some drugs being
barred from key overseas markets.
Many, including the country's biggest drugmaker Sun Pharmaceutical
Industries Ltd, are still struggling to fix issues at their generic
drug factories.
"FAR BEHIND"
Biosimilars have been available in India since the early 2000s, well
before their 2006 arrival in Europe and the recent introduction of a
regulatory pathway in the United States, where the first biosimilar
was launched only last month.
But India's experience has not been problem-free. Intas, for
example, recently received reports of some patients on its
biosimilar version of Roche's eye drug Lucentis developing
inflammation barely two months after the drug's launch.
An Intas spokesman said the problem was found to be in the drug's
"cold chain logistics" distribution channel and has restricted
supply of the drug.
Arun Chandavarkar, the chief executive of Biocon, seen by analysts
as the front-runner among Indian firms developing biosimilars,
believes the cost and complexity of developing biosimilars will be a
deterrent for many Indian players.
"At this time, there can't be too many companies willing to put in
that much effort and investment," he said.
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The three Indian companies that have stated plans to make
biosimilars for the United States and Europe are all partnered with
larger Western firms.
Biocon has a tie-up with Mylan Inc and is testing four molecules in
global Phase III trials, for which it plans to seek approvals in the
United States and Europe starting in fiscal 2017, Chandavarkar said.
Dr Reddy's is developing biosimilars such as rituximab and
pegfilgrastim for use in cancer treatment under a pact with
Germany's Merck KGaA and said it plans to launch its first
biosimilar in the United States by 2018.
A spokesman at Intas, which developed pegfilgrastim in partnership
with Canada's Apotex Inc, told Reuters the company was considering
partnering with a Swiss drugmaker to launch the product in the
United States. It declined to name the firm.
Chandru Chawla, head of Cipla Ltd's new ventures unit, said India's
"fundamental disadvantage" over United States, Europe and South
Korea was that biotechnology never evolved in India to the extent
that chemistry did.
"In terms of having the right knowledge ecosystem and the pools of
talent, India is far behind," he said.
Globally, Western pharmaceutical firms such as Novartis AG; Pfizer
Inc, in partnership with South Korea's Celltrion Inc; and Merck & Co
with partner Samsung Bioepis, are leading in the race to dominate
the Western biosimilars market.
"South Korea has made very significant strides in a very short
period of time," said Cartikeya Reddy, Dr Reddy's executive vice
president for biologics. "In this regard they have indeed pulled
ahead of Indian companies."
(Editing by Ben Hirschler and Rachel Armstrong)
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