Practice

According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

During the European Society for Medical Oncology (ESMO) Congress 2019, researchers provided a detailed look at a 3-treatment, 6-sequence crossover study for a pegfilgrastim biosimilar, and a separate team presented on the use of biosimilar filgrastim in patients who are being given chemotherapy regimens that involve a rest period of up to 14 days.

During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti–tumor necrosis factor biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.

Today, the FDA released a new suite of resources to educate patients about biosimilars.

During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.

While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.

Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.

Sandoz’s biosimilar filgrastim was first approved in Europe in 2009 under the name Zarzio (later, the same drug was approved as Zarxio in the United States). Since that time, the number of biosimilars approved for use in the oncology field has grown substantially, and a recent review says that the past decade of experience with biosimilar filgrastim underscores the strong scientific basis for the extrapolation of indications for biosimilars.

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.

The Center for Biosimilars® recaps the top stories for the week of September 9, 2019.

Just last week, Sandoz indicated that it will commercialize a biosimilar of the multiple sclerosis (MS) drug natalizumab (Tysabri). This week, during the 35th meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers will present data that help contextualize natalizumab’s place in the treatment paradigm for MS.

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.

For patients with rheumatoid arthritis (RA), avoiding damage to cartilage and bone in the joints is a key consideration for treatment. While anti–tumor necrosis factor (anti-TNF) therapies are used to treat RA and reduce joint destruction, the available anti-TNF agents, both originator and biosimilar, have not been directly compared with one another or with placebo in terms of their impacts on joint damage. A new study, published last week, attempted to address that gap in the literature by conducting a meta-analysis of randomized controlled trials (RCTs).

This week, British Columbia began the process of transitioning patients with inflammatory bowel disease (IBD) to biosimilars.

Recently, researchers reported on 7-year interim results from the STRIVE registry and said that the results show that most children are able to tolerate adalimumab plus methotrexate well.

As medicines become more numerous and often more expensive, healthcare professionals seek new ways to understand which treatments are most likely to yield the best outcomes at sustainable costs.

Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.

Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.

Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency.

A more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilars in the United States—is necessary, says the guideline.

“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”

Researchers examining the mandatory switch of patients with rheumatoid arthritis (RA) from the originator etanercept (Enbrel) to the biosimilar etanercept (Benepali) found no changes in overall healthcare utilization or cost of healthcare following the switch.

The Center for Biosimilars® recaps the top stories for the week of August 12, 2019.

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.