2016 has been a big year for biosimilars in rheumatology.
On Friday, the FDA announced the approval of Amgen's biosimilar version of Humira. The approval comes roughly 10 weeks after the FDA's Arthritis Advisory Committee unanimously voted, 26-0, in favor of approving ABP 501 based on clinical trials in rheumatoid arthritis (RA) and plaque psoriasis.
The anti-IL-12/IL-23 inhibitor, Stelara (ustekinumab) has been FDA approved for the treatment of psoriasis and psoriatic arthritis. In the last week, the EMA's CHMP has recommended that the drug also be approved for use in Crohn's disease.Today the FDA approved Stelara for use in adults with moderate to severely active Crohn's disease.
Dr. Jack Cush reviews highlights, news and articles from the past week at RheumNow.com:
Who makes billions in profits and millions in bonus monies? PBMs and insurers, thats who.
This week United Healthcare and Express Scripts announced new plans to restrict patient and prescriber access to popular, expensive, albeit FDA-approved, medications and biologics.
Who benefits, who loses?
What does sex have to do with it? Although the Zika virus infection is known to be sexually transmitted, the same cannot be claimed for Dengue or Chikungunya.
The world of PID (Primary immunodeficiency diseases) has changed remarkably over the past 5 years.
JAMA has reported the results of a 24-month trial showing that obese individuals on a long-term healthy diet and exercise program do not have significantly more weight loss from using a wearable device that tracks their activity.
Most US rheumatologists use multiple TNF inhibitors before switching. A new French study suggests that "other-MOA", non-TNF biologics are more effective after failing a TNF inhibitor.
A recent review has shown that tumor necrosis factor-α inhibitors (TNFi) rarely cause MS-like disorders. Although the Food and Drug Administration warnings on the label of all TNFis state "rare cases of new onset or exacerbation of central nervous system demyelinating disorders", the true incidence is not known.
In a study of published clinical trials, the frequency of reported multiple sclerosis was:
The osteoporsis therapeutics arena is starting to fill with new drugs and novel mechanisms of action.
A review of this week's news including the cost of opioid abuse, a RTX biosimilar, a new drug for scleroderma, a new shingles vaccine and a CPAP disappointment.
The Sept.16th issue of MMWR reports that many Americans over age 50 are not getting sufficient exercise, thereby increasing their risk for falls, fractures and comorbidities, if not premature death. (Citation source http://buff.ly/2cPAcq9)
The report analyzed data from the 2014 national Behavioral Risk Factor Surveillance System (BRFSS) telephone survey of US adults.
In the current issue of the NEJM, a Herpes zoster subunit vaccine was reported to be highly effective in adults - specifically in 2 studies (ZOE50 and ZOE70) targeting adults over age 50 and over age 70 years. (Citation source: http://buff.ly/2cMng17)
Updates and journal articles on opioids, drug induced sarcoidosis, cancer and cancer recurrence risks with TNF inhibitors and biologics, and FDA labeling changes.
