Kelly Davio

Officials in British Columbia announced on Monday that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months.

All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

In an analysis presented at ISPOR 2019, a team of researchers sought to demonstrate the cost to incorporate biologic treatment for patients with inflammatory diseases by using biosimilar infliximab instead of its reference.

Treatment with the biosimilar, the investigators concluded, resulted in comparable, maintained quality of life improvements that were not impacted by a switch from the reference product.

During Digestive Disease Week 2019, held May 18-21 in San Diego, California, researchers presented the 1-year results of a phase 1 trial of subcutaneous CT-P13 versus the intravenous formulation of the biosimilar in patients with Crohn disease (CD).

The FDA today released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity. A previous draft guidance document on statistical approaches to evaluate analytical similarity was withdrawn in June 2018.

Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.

During the ISPOR 2019 annual meeting, teams of investigators presented data estimating just how much healthcare systems could save by adopting biosimilar adalimumab for all indications of its reference in adult patients. The results highlighted both the scale of potential savings and the variability among European nations.

Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.

Research presented at this week’s ISPOR 2019 meeting sheds important light on the impact of biologics on the use of other healthcare resources.

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

The switch included patients with rheumatoid arthritis and psoriatic arthritis who were treated at a single center in Amsterdam, the Netherlands.

During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.

During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.

During the inaugural Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, Francisco Ballester, MBA, head of the international region for Sandoz, discussed some of the key considerations that biosimilar developers face in emerging markets with The Center for Biosimilars®.

This week, stakeholders from the legal, business, clinical, and development fields of the biosimilars landscape gathered in Amsterdam, the Netherlands, for the Biosimilars Commercialisation Summit 2019, a meeting dedicated to global issues in biosimilars market access. During the meeting, experts from around the globe discussed their experience with biosimilars and the opportunities and challenges that lie ahead.

Cost-effectiveness models for the treatment of rheumatoid arthritis (RA) first emerged in the early 2000s when highly effective but also high-cost biologic therapies began to reach patients. However, these health technology assessment (HTA) models need improvement, a recent paper says.

The FDA has released its long-awaited final guidance on demonstrating interchangeability of a biosimilar with its reference.

The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.

Yesterday, the federal circuit affirmed a district court’s decision in a patent dispute between Amgen and Sandoz.

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.

Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.

During this week’s Association for Research in Vision and Ophthalmology 2019 Annual Meeting, researchers presented new findings on the utility—and the delivery—of bevacizumab in eye disorders.

The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.

While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.