Generics makers set sights on complex generics, biosimilars

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Generics makers set sights on complex generics, biosimilars

By David Salazar - 06/12/2018
As the U.S. market registered another biosimilar approval — Mylan and Biocon’s Fulphila — more generics makers are telegraphing their plans to wade into more profitable waters by developing more biosimilars and complex generics. That’s the takeaway from recent presentations by generics mainstays Lupin and Dr. Reddy’s.

At the Morgan Stanley India Summit, Lupin managing director Nilesh Gupta highlighted the rough market that generics makers are facing, pointing to its own declining profit margins and market caps within the context of a 15% decline in market caps in the biggest seven players in the sector. Gupta also pointed to three areas that will be key drivers of growth — complex generics, large classes of which are still not seeing generics competition; biosimilars, which could pick up a piece of the $240 billion worldwide biologics market; and specialty/branded drugs, which Lupin has already begun exploring more with the recent launch of its bacterial vaginosis treatment Solosec.

As part of its strategic vision, Gupta said Lupin would build on its generics foundation to keep leading in the U.S. market while delivering on key complex generics, particularly around inhalation and injectable delivery systems. Gupta said the company also would look to file and commercialize biosimilars. On the branded side, the company will look to develop a robust women’s health portfolio, Gupta said.

Also looking to diversity its generics and make a larger foray into branded products is Dr. Reddy’s. At the Jefferies Annual Healthcare Conference, the company outlined a growing focus on biosimilars and complex dosage forms in North America.

By 2021, the company is aiming to have more than 50% of its revenue come from such complex dosage forms as injectables and topicals — a group that currently makes up roughly 30% of its revenue. Dr. Reddy’s also will focus on monetizing its biosimilars assets, which include its biosimilar rituximab Reditux, which it has commercialized in 14 countries. Dr. Reddy’s also highlighted its pipeline, which include 107 pending applications for generics, as well as three applications for new drugs. The company also signaled an increased interest in OTC products.

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