Celltrion gets FDA clearance for biosimilar Truxima
The Food and Drug Administration has approved Celltrion’s Truxima (rituximab-abbs) as the first biosimilar to Genentech’s Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma, or NHL, to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.
“As part of the FDA’s Biosimilars Action Plan we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines,” FDA Commissioner Scott Gottlieb said.
“The Truxima approval is our third biosimiliar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval,” Gottlieb said.
Truxima is indicated for the treatment of adult patients with: relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing, including stable disease, low-grade, CD20 positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone chemotherapy.
Dr. Reddy’s launches generic chlorthalidone tablets
Dr. Reddy’s Laboratories is introducing chlorthalidone tablets in 25 mg and 50 mg dosage strengths.
The product is a generic version of Hygroton’s chlorthalidone tablets,. It is used to treat high blood pressure, or hypertension.
Dr. Reddy’s chlorthalidone 25 mg tablets are available in 100 and 1,000 bottle count sizes, and its 50 mg tablets are available in 100 count.
The Hygroton brand and generic had a market value of approximately $122 million for the twelve months ending in September 2018, according to IQVIA.
CVS Health, Northwell Health to increase HIV testing in NYC area
Northwell Health is launching a new pilot program to help increase access to HIV testing and promote prevention efforts in New York’s Long Island and Queens communities.
Clinicians and outreach workers from Northwell’s Center for AIDS Research and Treatment, or CART, at North Shore University Hospital in Manhasset, will collaborate with CVS Health to provide free, on-site HIV testing via Northwell’s mobile health van parked at select CVS Pharmacy locations throughout the area.
The effort will launch at the CVS Pharmacy in West Hempstead, located at 814 West Hempstead Ave., and is slated to start the third week of December.
The mobile health van will expand to other CVS Pharmacy locations during the first quarter of 2019.
CART staff will provide educational training to CVS staff and pharmacists about various aspects of HIV testing and screening.
CVS Health has donated 500 HIV in-home test kits, which allows people to perform an oral swab in the privacy of their home.
Northwell plans to distribute the home testing kits at venues such as club nights and locations where the outreach team may be able to identify undiagnosed individuals who are at risk for the virus and are reluctant to walk into a health van to be tested.
The initiative is being announced ahead of the 30th anniversary of World AIDS Day, with the goal of providing health resources for people living in high-risk communities and to educate those who may not know they are living in such areas.
“This new collaboration between Northwell and CVS Health will make a significant difference in increasing awareness about HIV testing in the communities we serve, improving the health of people who are HIV+ and supporting education efforts about preventing HIV,” CART medical director Joseph McGowan said.
McGowan’s research identified local HIV “hot zones” – Hempstead, Westbury, Huntington Station on Long Island, and Rosedale and surrounding areas in Eastern Queens.
The latest reports show there are 130,000 people living with HIV in New York State. On Long Island alone, 6,810 people are HIV-positive. In Queens, nearly 18,000 are infected with the virus. Approximately 1,000 Long Islanders are unaware that they are HIV+ and thousands more are at risk for the disease, McGowan said.