Ustekinumab-stba (Steqeyma) now has FDA approval for all forms and dosages of its reference product, ustekinumab (Stelara), including a subcutaneous injection to treat pediatric patients with plaque psoriasis or psoriatic arthritis.
When Switching Patients to Biosimilars, Communication & Expert Nurses Reduce the Nocebo Effect
In a recent study, researchers designed an intervention centered on communication and led by nurses to address discontinuation rates among patients who had switched to a biosimilar. The nurses’ insight and experience reduced the nocebo effect during the intervention, which had an 84% retention rate for patients taking a biosimilar after one year.
British Columbia Will Be First Canadian Province to Switch Patients to Biosimilars
TORONTO/MONTREAL (Reuters)—The Canadian province of British Columbia said on May 28 that its public drug plan will switch as many as 20,400 patients from three branded biologic drugs to cheap near-copies called biosimilars, saving an estimated C$96.6 million ($71.9 million) over three years. The new policy from the province’s PharmaCare program targets Johnson & Johnson’s…
Canada Approves Erelzi for PsA; Plus FDA Moves to Increase Access to Naloxone
Health Canada has approved Erelzi, which is biosimilar to Enbrel (etanercept), for treating psoriatic arthritis in adults…
EU Grants Marketing Authorization for Hyrimoz; Plus FDA Rejects New Drug Application for Buprenorphine Sublingual Spray
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
The Science Behind Biosimilars
Although six biosimilar agents have now been approved by the U.S. Food & Drug Administration for use in rheumatology, scientific, clinical, economic and prescribing questions about the use of biosimilars abound. In fact, at the 2017 ACR/ARHP Annual Meeting in San Diego, Joseph Huffstutter, MD, a rheumatologist in private practice in Chattanooga, Tenn., said that…
Biosimilars: Still Waiting for Promise to Materialize
During the 2017 ACR/ARHP Annual Meeting, advances in biosimilar treatments were abuzz. However, many speakers noted that the presence of biosimilars on the market has not yet resulted in greater access to treatment and lower drug pricing in the U.S…
Sequential Therapy May Reduce Hip Fracture Risk; Plus New Biosimilar Available in Canada
Patients who receive abaloparatide and switch to alendronate have a statistically significant reduction in fracture risk through 3.5 years, according to a new study…
U.S. Supreme Court Speeds Copycat Biologic Drugs to Market
WASHINGTON (Reuters)—The U.S. Supreme Court on Monday cut the time it will take for copycat versions of biologic drugs to get to the market in a pivotal ruling about an expensive class of medicines that can yield billions of dollars in sales for drug companies. The justices, in a 9–0 ruling, overturned a lower court…
Nevada Rheumatologists Take on Biologic and Biosimilar Substitution
On March 22, 2017, Ewa Olech, MD, testified at a hearing before the Nevada State Assembly to voice support for A.B. 245, a bill governing biologic medications and biosimilar substitution in that state. She spoke on behalf of the Rheumatology Association of Nevada (RAN), as its president and founder. The bill establishes guidelines regarding biosimilars and requires…
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