News

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

Although switching patients with rheumatoid arthritis to a second biologic disease-modifying anti-rheumatic drug when their disease has failed to respond to the first agent is generally advocated, no consensus exists on whether the second agent should have the same or a different mechanism of action.

Maryland’s House Bill 631, which is scheduled to take effect in October 2017, is facing a lawsuit filed by the Association for Accessible Medicines, which calls the bill unconstitutional.

Biologic agents represent the highest single cost associated with rheumatoid arthritis (RA) infusion care, a new analysis finds, with personnel, supplies, and overhead costs contributing substantially to overall costs.

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).

Several biosimilar etanercept products are now approved in the United States and in Europe, and several more “intended copy” versions are approved in poorly regulated countries. Availability of an international reference standard would allow qualification of assays for determining biological activity of intended copies or biosimilars.

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

USV, a Mumbai-based pharmaceutical company, announced on Thursday that it had successfully completed phase 1 and phase 3 studies on a proposed pegfilgrastim biosimilar referenced on Neulasta. The company expects to submit data for its marketing authorization application to the European Medicines Agency before the end of 2017.

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.

This week, FDA commissioner Scott Gottlieb, MD, announced that the agency’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to integrate drug review programs with facility evaluations and inspections.

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

Insulin degludec (Tresiba) is a cost-effective alternative to insulin glargine U100 (Lantus) for patients with diabetes, and it is also likely to be more cost-effective than 2 newly marketed basal insulin analogues, including a biosimilar.

A recent paper published in the World Journal of Gastroenterology examines the complexities posed by biologics and biosimilars in the transition care of adolescent patients who have inflammatory bowel disease (IBD).

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.

Following the Supreme Court’s decision in Sandoz v Amgen, both drug makers have filed, in compliance with the Federal Circuit court’s order, supplemental briefs. These briefs state the parties’ opinions on the appropriate action to be taken after the Supreme Court remanded the case to the lower courts.

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.

In recent years, drug spending has increased with the launches of new, high-cost drugs and with price hikes for established drugs. One method of controlling such increases in drug spending is reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class.

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.

Genentech, a member of the Roche Group, announced on Sunday that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted a priority review for the company’s obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone, for patients who have previously untreated follicular lymphoma.

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.

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.