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.
FDA report highlights savings from 2017 approvals
The Food and Drug Administration has released a report focusing on the savings that generic approvals brought the healthcare system in 2017. The report is the first of its kind from the FDA’s Office of Generic Drugs, and notes that the FDA fully approved 843 Abbreviated New Drug Applications, issuing tentative approval to a further 184 ANDAs.
The agency’s report estimates that savings from 2017 approvals through February 2018 totaled $11.8 billion, with $8.8 billion in savings through December 2017. Further, the report estimates that in one full year after each generic approval from last year, the savings will be $16 billion.
To reach its estimates, the FDA created a dataset using the 2017 ANDA approvals in the FDA’s Orange book, the NDC numbers of the approvals from various sources, a defined market parameter and monthly sales of all products with the same ingredients/route/dosage form as the 2017 approvals, including the branded drug and previously approved ANDAs. The agency noted that the sales data it looked at did not reflect rebates, discounts or off-invoice adjustments and that it measured market impact following approval rather than marketing. It also did not look at the impact of tentatively approved drugs because of delays that occur before full approval and exclusivity issues.
“FDA approved a record number of generic drug applications in 2017,” the report says. “Since its inception in 1984, the generic drug approval pathway has played a critical role in increasing access to safe, high-quality, and affordable medicines for the American public.”