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Pharma cos Race to develop SUPER - GENERICS

(This article appeared in / CNBC TV18, dated 08 May 2012)

For Indian generic drug-makers, it's not so much about volumes anymore as it is about margins. And many have found that innovation into more complex molecules or into advanced drug delivery systems will do the trick, reports CNBC-TV18's Archana Shukla.

Boring white pills no longer do the trick from a marketing perspective. With falling margins and increasing competition, generic drug manufacturers are looking at innovation to get to the next big league - super generics.

The idea is simple: get a complex molecule that cannot be replicated as easily and open doors to lasting revenue streams and upto a 40% premium on the existing generic.

Abhay Muthal, senior GM - regulatory affairs, Sun Pharma, "These will be
 difficult to develop, but will meet the unmatched needs of the consumer. They can be targeted with a technology or a device, offer continuous revenue streams and offer exclusivity on the drug. All these characteristics make super-generics very lucrative."

It's not just about creating a complex molecule. A
super generic may be as simple as a more advanced delivery system that increases effectiveness or makes delivery simpler - like oral insulin or insulin patches, instead of injectible insulin.

Indian players are taking a leaf from global generic giants like Teva, Actavis and Watson, who already have such portfolios. Dr Reddy's Laboratories has chosen to go the unreplicatable drug route with its
tough-to-copy blood-thinner Fondaparinux. Both Dr Reddy's Laboratories and Natco Pharma have made generic filings for other advanced drugs like the multiple sclerosis drug Copaxone and cancer treatment drug Revlimid.

Meanwhile, Sun Pharma is focusing its R&D capabilities on innovative delivery platforms for its ophthalmic drugs and oral contraceptives.

Cadila, armed with newly-acquired Nesher Pharma, is looking at
newer drug delivery modes for its pain-killer Diclofenac, among other drugs.

While others like Lupin are also catching on, it is not an easy ride. Sanjay Chaturvedi, head-global sales & VP-marketing, Dr. Reddy's Laboratories, "There are lot of challenges. India is the biggest market for us. But it is an unbranded market. So need to spend more on promotional activities."

"The EU market is highly fragmented and the rewards will only come if you can market the Products in a larger market. The other challenge is that formulation skills of Indian pharma companies need to be honed to make these innovations cost-effective, " Chaturvedi added.

The regulatory pathways for many of these innovative drugs, like biosimilars, are muddled. But with super generics capable of generating seven-to-ten times the value of simple generic, they are just too lucrative an opportunity to be passed on.