Strides’ generic Tamiflu approved
The Food and Drug Administration has approved Strides Pharma’s generic Tamiflu capsules (oseltamivir phosphate capsules). The drug is indicated to treat symptoms caused by the flu virus and shorten recovery time.
The Strides Shasun subsidiary said that the product has seen volume growth in the past year due to a strong flu season. IQVIA data shows a market size for generic Tamiflu of roughly $725 million for the 12 months ended April 2018. Strides said the product would be manufactured at its oral dosage facility and Bangalore.
The product will be available in 30-, 45- and 75-mg (base) dosage strengths.
Glenmark gets FDA OK for Hailey, Hailey Fe
The Food and Driug Administration has approved two birth control products for Glenmark’s branded generics of Loestrin 21 and Loestrin Fe 1.5/30. The company’s Hailey (norethindrone acetate and ethinyl estradiol tablets 1.5 mg/30 mcg) and Hailey Fe (norethindrone acetate and ethinyl estradiol tablets, 1.5 mg) USP and ferrous fumarate tablets, 1.5 mg/30 mcg) are indicated to prevent pregnancy in women.
Hailey will enter a market whose size was roughly $24.2 million for the 12 months ended April 2018, and Hailey Fe will enter a roughly $41.3 million market for the 12 months ended April 2018, according to IQVIA data. Glenmark said it currently has 61 generic applications pending before the FDA.
Generics makers set sights on complex generics, biosimilars
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.