Practice

The findings indicate that interventions that leverage physician relationships may assist with increasing uptake of new, high-value cancer treatments in place of low-value therapies.

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

The Center for Biosimilars® recaps the top stories for the week of December 30, 2019.

The Inflammatory Bowel Disease Net, an official working group of the Swiss Society of Gastroenterology, has issued a new position statement on the use of biosimilars in treating inflammatory bowel disease (IBD).

Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment.

At the United European Gastroenterology Week 2019, held in Barcelona, Spain, earlier this year, a research team from the Netherlands reported on the prevalence of patients with inflammatory bowel disease (IBD) switching back to the reference infliximab after a previous switch to biosimilar CT-P13, and found that switching back appeared to be effective in patients with IBD.

Using the same dosing as treatment for lymphoma and older age were linked with higher odds of complete remission off therapy.

Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

At 6 months and 1 year, respectively, survival rates among the suboptimal responders who stayed on their index anti–tumor necrosis factor (anti-TNF) agent were 90.2% and 85.1%, respectively.

Using a biosimilar can produce substantial cost savings in patients who are receiving infliximab therapy for inflammatory diseases like rheumatoid arthritis (RA), but dose escalations, which are frequent for those who use infliximab, can increase the cost of therapy, even with a biosimilar.

During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar filgrastim could result in substantial savings.

As yet, there exists no consensus as to whether proactive or reactive monitoring is the most appropriate approach in patients with inflammatory bowel disease (IBD) who receive infliximab therapy.

Interestingly, nocebo effects may also be induced by exposure to information shared online, through social media, through drug advertisements, and advertised descriptions or warnings about health-related conditions. The effect can be profound; the authors said negative expectations underlying nocebo phenomena have been shown to alter activity in certain regions of the brain.

While there is no question that falling prices that come with competition are cause for optimism in the United States, which is burdened by rising drug costs, some experts from Europe caution that a focus on price alone misses key reasons to use biosimilars.

Researchers from biotech company Tetra Therapeutics have reported that, in their retrospective population-based study of 56 million patients with inflammatory diseases, use of anti–tumor necrosis factor (anti-TNF) agents was linked with a reduced risk of Alzheimer disease.

In Crohn disease (CD), anti–tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.

Mylan and Biocon have announced that their biosimilar trastuzumab, Ogivri, has become commercially available in the United States. The biosimilar, referencing Herceptin, is now available in a 420-mg multidose vial and a 150-mg single-dose vial.

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

The American Medical Association (AMA) wants medical schools and residency programs to start training medical students and residents in healthcare economics.

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

This week, a study from Spain retrospectively compared direct costs of intravenous and subcutaneous reference rituximab in the setting of lymphoma, taking into consideration drug costs, pharmacy costs, and chair time-related costs at a single center in 2017. They also conducted the same analysis using the costs of biosimilar rituximab.

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).

The field of biosimilar contenders for anti–vascular endothelial growth factor (anti-VEGF) therapies is taking shape, with biosimilar developer Coherus seeking to launch its ranibizumab biosimilar in 2021 and Samsung Bioepis having reached a commercialization agreement for 2 biosimilar anti-VEGFs of its own. Last week, a study published in JAMA Ophthalmology supported the use of anti-VEGF agents in wet age-related macular degeneration (AMD), saying that, though these drugs are costly, they may provide substantial economic value to both patients and society.

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

While US patients continue to wait for a biosimilar etanercept to become commercially available, real-world data continue to amass for Samsung Bioepis’ biosimilar, SB4, in European clinical practice. The biosimilar, sold as Benepali in the European context, was the subject of several studies presented this week at the American College of Rheumatology’s 2019 meeting, held in Atlanta, Georgia.

Among the first biosimilars to gain US approval was Sandoz’s etanercept biosimilar, GP2015, or Erelzi. The product was authorized by the FDA in 2016, but it has not yet launched in the US market due to long-running patent disputes related to Amgen’s innovator product, Enbrel. In other markets, however, the biosimilar is a widely used treatment option, and data presented at the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, show that not only is the biosimilar safe and effective in real-world practice in ex-US markets, but it could also bring about substantial savings in the United States once it becomes available.

The results will inform will inform counseling and management of pregnant women with inflammatory diseases who need tofacitinib or non-tumor necrosis factor inhibitors during pregnancy, said the author.

Over the past few years, awareness of biosimilars has been increasing; however, research presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, shows that while US rheumatologists hold growing awareness of biosimilars, hesitancy remains around such issues as switching stable patients and the extrapolation of indications.

The great promise of biosimilars is their ability to provide high-quality treatment at a reduced cost, thereby producing cost savings that can be reapplied. But how are healthcare systems around the globe utilizing those cost savings? During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held this week in Copenhagen, Denmark, several teams of researchers reported on how biosimilars are impacting international markets, and how they could provide headroom for new, expensive treatments.