Dr. Reddy’s earns FDA approval for Doxil generic
PRINCETON, N.J. — Dr. Reddy’s Laboratories announced on Wednesday that it has received Food and Drug Administration approval to launch doxorubicin hydrochloride liposome injection, a therapeutic equivalent generic version of Janssen Products’ Doxil (doxorubicin hydrochloride liposome injection), for intravenous use, in the United States market.
The product is indicated to treat ovarian cancer.
According to Dr. Reddy’s, FDA approval is an outcome of extensive collaboration with the company’s partner, Natco Pharma on research and develop and manufacturing capabilities.
“This approval represents the first of its kind for Dr. Reddy’s in the complex depot injectables arena,” said Alok Sonig, EVP and head of the North America generics business at Dr. Reddy’s Laboratories. “It is a testament to our commitment to bring affordable generic medicines to market for patients. The approval further validates our capabilities to successfully develop and manufacture complex liposomal formulations. We are preparing for a commercial launch soon.”
Dr. Reddy’s doxorubicin hydrochloride liposome injection is a sterile, translucent, red liposomal dispersion in 10-mL or 30-mL glass, single-dose vials. Each 10-mL vial contains 20 mg doxorubicin hydrochloride at a concentration of 2 mg/mL. Each 30-mL vial contains 50 mg doxorubicin hydrochloride at a concentration of 2 mg/mL.
“We are pleased with our partnership with Dr.Reddy’s Laboratories. This approval would not have been possible without their guidance and support,” said Rajeev Nannapaneni, vice chairman and CEO, Natco Pharma.
The Doxil brand and generic had U.S. sales of approximately $196 million MAT for the most recent twelve months ending in March 2017 according to IMS Health.
Recycling bad ideas
The other day, I saw a young man in baggy jeans — that ridiculously enormous cut from the late 90s/early 2000s that seemed to fit every waist size from 28 inches to 4.5 ft., and gave every person the illusion of being their own “after” picture in one of those bad billboard weight loss ads. It was just another reminder that either, for a lack of creativity or extremely bad taste, every bad idea that ever existed eventually will be recycled.
Kind of like we are seeing right now in Washington with health reform: Politics aside, with the exception of a few bright spots, the highly anticipated proposed replacement to the Affordable Care Act, the American Health Care Act, if fully enacted, would represent a step backward in thinking around how to improve health care in this country.
That’s not to suggest that the ACA was perfect. Far from it; the legislation did a lot to expand access, and it got people focused on such important things as the quality of care and realigning incentives around outcomes versus fees-for-service, but it also failed to really lower overall costs.
You could say that allowing insurers to compete across state lines probably would have created more competition in the exchanges, and theoretically helped lower costs. You also could say that the individual coverage mandate under the ACA needed to be reexamined, but it’s hard to argue against making sure every American has basic health insurance. The reality is that Americans have been paying through the nose for years to cover the costs of the uninsured that go without routine, basic care only to wind up later in the emergency room, or on the operating table.
While it may be still too early to tell, according to community pharmacy advocates, it appears that the AHCA would offer mostly a mixed bag to the industry, with maybe a handful of positives. According to an online poll of DSN readers, 41% expect the AHCA to have the most positive impact on OTC sales; 35% expect retail clinics to be the big winners; and just 24% believe pharmacy will benefit most.
On the pharmacy side, it’s hard to imagine that any reduction in the number of covered lives could lead to an increase in script utilization, and the AHCA’s cap on per-patient Medicaid spending also could negatively impact that area of the business.
On the flip side, the AHCA could speed up the pace of new drug development by repealing billions of dollars in pharmaceutical manufacturer taxes, which could enable a broader focus on innovation.
Meanwhile, the prospects for self-care could improve under the AHCA, which would restore eligibility for OTC purchases under Healthcare Savings Accounts and Flexible Spending Accounts.
Separately, but on a somewhat related note, it appears that some members of Congress are noodling with the idea of allowing drug reimportation as part of the discussion around retooling Prescription Drug User Fees — further evidence that all bad ideas are cyclical. Just like those horrible baggy jeans.
How CVS improves patient health
WOONSOCKET, R.I. — Improving patient care is constantly on the mind of CVS Health. In fact, this has been constantly on the mind of Stephen Gold, who has served as the retailer’s EVP and CIO since 2012.
Gold sat down for an interview with the Wall Street Journal where he talked in detail about patient care and patient health. Regarding what CVS has done to improve patient care, “Some of it is technological, some of it is process, and some of it is people and culture,” he told the newspaper. “At the tip of the spear would be what we’re doing in our innovation laboratory in Boston, where the goal is to basically operate in a mode that mimics a startup. A mind-set of experimentation, iteration, rapid testing and failure is part of the process. This laboratory is focused on bringing new digital products and services to market.”
As for sources of data related to patient health: “The data we get from patients’ prescription behaviors is key,” Gold said. “It’s the patient’s profile, their gender, their age, any allergies they may have, any disease state. All the information that is needed to appropriately care for the patient. We also have a proprietary platform that we call the health engagement engine, which is basically a very sophisticated, clinically focused customer-relationship management system that allows us to transform health-care data into actionable interventions that improve outcomes and reduce costs. We’re constantly expanding the number of interventions and use cases that can be delivered through this platform.”
To read the full interview, click here.