FDA approves Humira-biosimilar Cyltezo
SILVER SPRING, Md. — The Food and Drug Administration last week approved Boehringer Ingelheim's Cyltezo (adalimumab-adbm) subcutaneous injection, a new biosimilar to AbbVie's Humira (adalimumab).
"Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients," stated Ivan Blanarik, SVP and head of therapeutic area biosimilars at Boehringer Ingelheim. "Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo has the potential to deliver significant benefits to many of these individuals."
The FDA approval is based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that Cyltezo is biosimilar to Humira.
Cyltezo is not commercially available at this time, however. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie. Boehringer Ingelheim will also seek approval for an auto-injector of Cyltezo, as another delivery option for patients.
The first Humira biosimilar, Amgen's Amjevita (adalimumab-atto), was approved by the FDA in September 2016.
Cyltezo is a recombinant tumor necrosis factor blocker and is indicated to treat adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn's disease, moderately to severely active ulcerative colitis and moderate-to-severe plaque psoriasis.
In pediatric patients, Cyltezo is indicated to treat moderately to severely active juvenile idiopathic arthritis in children over the age of four.
Cyltezo will be available as 40mg/0.8mL strength pre-filled glass syringes in 2-count cartons.
New research quantifies the impact of the opioid epidemic
BOSTON — A new study of the growing United States opioid epidemic found that deaths from overdoses have nearly doubled over the past seven years, while increasing acute care costs and hospitalizations are taxing health care systems.
The new paper, "The Critical Care Crisis of Opioid Overdoses in the United States" published online ahead of print in the Annals of the American Thoracic Society is believed to be the first to quantify the impact of opioid abuse on critical care resources in the U.S. The findings reveal that opioid-related demand for acute care services has outstripped the available supply.
In the cohort study, researchers from Ben-Gurion University of the Negev in Israel, Harvard Medical School and University of Chicago analyzed nearly 23 million adult hospital admissions at 162 hospitals in 44 states over a seven-year period: January 1, 2009 through September 30, 2015. Among the more than 4 million patients requiring acute care, the researchers found 21,705 who were admitted to intensive care units due to opioid overdoses. Admissions included overdoses for prescription drugs, methadone or heroin.
"We found a 34% increase in overdose-related ICU admissions while ICU opioid deaths nearly doubled during that same period," stated Lena Novack, a lecturer in BGU's School of Public Health. The mortality rates of these patients climbed at roughly the same rate, on average, with a steeper rise in deaths of patients admitted to the ICU for overdose after 2012.
The average cost of care per ICU overdose admission also rose significantly – 58% – from $58,517 in 2009 to $92,408 in 2015. In addition, the study indicated that opioid-related ICU admissions increased an average of more than half a percent each year over the seven-year timeframe, jumping from 7% to 10% by the end of the study period.
Patients admitted to the ICU due to an overdose increasingly required intensive care, including high-cost renal replacement therapy or dialysis.
"Our estimates may actually be on the low side," Novack said. "Since our team of researchers analyzed admissions rather than a manual chart review, we may not have captured every admission if opioid-related complications weren't coded as such."
The researchers found that Massachusetts and Indiana had the highest opioid admission densities in the nation. Pennsylvania experienced the sharpest rise in opioid-related overdoses during the study period, with critical care overdose admissions nearly doubling since 2009. Illinois, California, New York and Indiana have also experienced ICU admission rate increases during the period.
"Our findings raise the need for a national approach to developing safe strategies to care for ICU overdose patients, to providing coordinated resources in the hospital for patients and families, and to helping survivors maintain sobriety following discharge," the researchers concluded.
Medi-Dose and EPS publish white paper on bar coding in healthcare settings
IVYLAND, Pa. — It’s essential for healthcare professionals to follow the five tenets of medication dispensing and administration: the right patient, the right drug, the right dose, the right route and the right time. Within every facility, systems are instituted to ensure these five tenets are observed. Bar codes can play an important role in medication dispensing, helping healthcare professionals ensure they are administering drugs to the right patients correctly. But many people don’t know how bar codes work, or which bar code options are best for their systems.
To help healthcare professionals better understand bar coding, Medi-Dose and EPS have released a white paper called, “Bar Codes and Bar Code Scanners for Unit Dose Medication in a Healthcare Setting.” It explains how bar codes work, the types of bar codes and scanner that are available and how to best termine the best equipment and bar code options for unit dose medications.
Click here to see the white paper.
For more than 45 years, Medi-Dose and EPS have been working with pharmacists and nurses to develop cost-effective solutions that promote medication safety and error prevention.