Practice

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

Several small studies have suggested that ultra–low-dose treatment with rituximab leads to good treatment responses in patients with rheumatoid arthritis compared with standard low-dose schedules of rituximab.

Newly published results of a phase 3 study of baricitinib, a once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA), show that the small-molecule drug provided greater improvements in patient-reported outcomes than either placebo or the biologic adalimumab (Humira).

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 28, 2017.

The Lazio region of Italy had one of the lowest uptakes of biosimilars in the country. In response, specific guidance was issued for the region in November 2015.

Ireland’s National Cancer Control Programme (NCCP) has issued new guidance on the use of biosimilar medicines in the treatment of cancer.

A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in many patients who take these biologics, and leads to higher costs.

Biocon announced today in a letter to the National Stock Exchange of India that the FDA has extended its target action date for a regulatory decision on the drug maker’s trastuzumab biosimilar.

Treatment strategies involving anti-tumor necrosis factor dose tapering or withdrawal among rheumatoid arthritis patients who are achieving disease control are gaining popularity. Such strategies seek to optimize benefits versus risks with respect to both patient preferences and the high costs of biologic treatments.

A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis and healthcare providers who treat patients with RA.

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Cost-effectiveness evidence has come to play a prominent role in decisions regarding the approval of expensive biologic treatments, such as those for psoriatic arthritis (PA). However, cost-effectiveness evidence for PA treatments has been difficult to develop because of the lack of a robust evidence base.

Providing prophylactic treatment with granulocyte-colony stimulating factor to patients receiving chemotherapy may yield better chemotherapy-induced neutropenia, febrile neutropenia, and related hospitalization outcomes if patients receive prophylaxis at levels above guideline recommendations, according to a recent study.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

A study published in the British Journal of Clinical Pharmacology demonstrated the bioequivalence of GP2015, a biosimilar etanercept treatment (Sandoz’s Erelzi), when delivered with an auto-injector and when delivered with pre-filled syringe in patients across a variety of body weights.