As far as sobriquets go, nothing can be nobler than the ‘pharmacy of the world’. Indian pharmaceutical companies have earned it. They supply 40% of the $70 billion generics market in the US, though it’s another matter that their dominance is under stress today. Their oversight on quality has come to pass and in spades. So, when India’s largest drug company, Sun Pharma, said last week that it had inked a long-term partnership with Samsung Biologics to manufacture its new drug, it signalled a shift. Manufacturing prowess of the past may not be enough for the drugs of the future.

Sun’s new drug, tildrakizumab, is a novel biologic, unlike its other drugs, which are largely generics of small molecules made from chemical synthesis. Biologics are drugs, which are produced in living systems, in animal or plant cells. Tildrakizumab is a molecule, which Sun licensed from Merck in 2014 for an upfront payment of $80 million and later funded its further development.

At one level, Sun’s decision looks simple. Samsung, because of its partnership with Merck, has supplied the drug throughout its development so let it continue to supply when Sun takes it to the market. Why upset the regulatory cart? When asked if the decision was based on economic or scientific reasons, Kirti Ganorkar, Sun’s global head-portfolio management and business development, said, “For a complex biologic product like tildrakizumab, we wanted to leverage Samsung’s manufacturing knowledge and world-class quality systems.”

The US entry

The US FDA Advisory Committee meeting on July 13 gave a positive nod to Biocon and its exclusive partner, Mylan, for their filings in the US for biosimilar trastuzumab, the popular breast cancer drug. This takes the duo one step closer to commercializing the first biosimilar of this drug in the US market

To put it in context, Sun and other big Indian pharma companies have limited ­capability to develop and manufacture ­biologics or their off-patent generic versions called biosimilars. This, at a time, when nine of the top 10 best-selling drugs in the world are biologics, which are expensive but also more effective. Nearly $38 billion worth of biologics are losing patent protection in the next two years. That opens up a huge biosimilars market, which few Indian companies are prepared to make much of. Understandably so. If it costs $500,000 to $1 million to develop and manufacture a generic drug, it costs anywhere from $50 million to $100 million to develop and manufacture a biosimilar.

That’s very serious money for any Indian drug company to commit. Especially so because copying biologics is far trickier than copying a small molecule drug.

With Korean and Chinese manufacturers ready to steal the show, India came out with a $250 million Biopharma Mission on 30 June, with half the money coming from the World Bank.

AUTHOR

Seema Singh

Seema has over two decades of experience in journalism. Before starting The Ken, Seema wrote “Myth Breaker: Kiran Mazumdar-Shaw and the Story of Indian Biotech”, published by HarperCollins in May 2016. Prior to that, she was a senior editor and bureau chief for Bangalore with Forbes India, and before that she wrote for Mint. Seema has written for numerous international publications like IEEE-Spectrum, New Scientist, Cell and Newsweek. Seema is a Knight Science Journalism Fellow from the Massachusetts Institute of Technology and a MacArthur Foundation Research Grantee.

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