News

Mixed cryoglobulinemic vasculitis—a rare disorder that is characterized by the presence of abnormal proteins in the blood that become insoluble at low temperatures and restrict blood flow—may be successfully managed with the use of rituximab as a generally well tolerated, glucocorticoid-sparing therapy.

The FDA Friday issued a black box warning for the 10-mg, twice-daily dose of tofacitinib, sold under the names Xeljanz or Xeljanz XR; the drug is an oral, small-molecule Janus kinase (JAK) inhibitor. In addition, this week researchers released phase 3 study results of an investigational JAK inhibitor, filgotinib; the drug showed a clinical response, but the researchers said additional work is needed to assess long-term efficacy and safety.

Fourteen parties have submitted comments on the guidance; in addition to other concerns with the document, including calls for clarification on the use of non-US comparator products and the potential for the waiver of bridging studies in the biosimilar development process, some drug makers called on the FDA to clarify issues associated with lot-to-lot variation and quality attributes.

The Center for Biosimilars® recaps the top stories for the week of July 22, 2019.

A patient-level simulation model using real-world data from Finland evaluated the cost-effectiveness of abatacept, tocilizumab, and anti–tumor necrosis factor (anti-TNF) therapies as compared with rituximab in patients with rheumatoid arthritis (RA) who received previous treatment with an anti-TNF agent.

JCR Pharmaceuticals, together with partner Kissei Pharmaceutical, is currently developing a darbepoetin alfa biosimilar, JR-131, referencing Aranesp. Darbepoetin alfa is used to treat anemia caused by chronic kidney disease or by chemotherapy.

Among the data that supported the biosimilar’s approval was a phase 3 study in patients with advanced nonsquamous non–small cell lung cancer. This week, researchers published detailed findings from that study.

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.

The FDA Tuesday approved Samsung Bioepis’ Hadlima (adalimumab-bwwd), referencing Humira.

A bipartisan bill introduced in the Senate Monday calls for cutting insulin prices up to 75% via a measure aimed at insurers and pharmacy benefit managers (PBMs). The bill, introduced by Senator Jeanne Shaheen, D-New Hampshire, would prohibit PBMs and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels.

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

This month, the president and chief executive officer of Green Shield Canada, the fourth-largest private payer in Canada, hailed British Columbia’s strategy as “forward-thinking” and “essential to maximizing opportunities in healthcare.”

"We argue that the default should be that biosimilars are interchangeable, unless there is compelling evidence otherwise," write Hans C. Ebers, PhD, of Biogen, and Hubb Schellekens, MD, PhD, of Utrecht University.

Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.

Was political infighting within the administration a reason for withdrawal of the rebate rule? That would certainly be a sad testament to our political system.

Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.

Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.

Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

The Center for Biosimilars® recaps the top stories for the week of July 15, 2019.

The top 3 drugs in 2018 in the United States by spending were adalimumab, insulin glargine, and etanercept, according to a study in The American Journal of Health-System Pharmacy, which also predicted that drug spending will grow 4% to 6% this year.

Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.

The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis and 45 with Crohn disease, at 14 centers in Italy.

A hospital for rheumatological diseases in the United Kingdom is participating in an international study that is examining real-world evidence about patient experiences after they switch from reference adalimumab (Humira) to a biosimilar, Imraldi.

A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.