News

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).

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.

With drug costs continuing to spiral and slower uptake in the United States compared to other parts of the world, it is perhaps natural for observers of biosimilars to ask questions, not only about well-known patent issues, but about deeper issues, such as the way biosimilars are developed, the meaning of interchangeability, and perhaps the very structure of the industry itself. Here’s a look at 5 hot topics from 2019.

When it comes to US biosimilars, 2019 was the busiest year yet for regulatory activity, with a bevy of new approvals and the publication of long-awaited guidance documents.

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

Intravitreal injection with anti–vascular endothelial growth factor (anti-VEGF) drugs has represented a major step forward for patients with retinal diseases, and the upcoming biosimilars market for these drugs—including aflibercept and ranibizumab, as well as off-label bevacizumab—is beginning to take shape. However, there have been some lingering concerns about the safety of these drugs, as increased mortality has been reported after anti-VEGF treatment in the general population.

During 2019, The Center for Biosimilars® provided interviews and discussions with key opinion leaders on our podcast to discuss various issues affecting biosimilars. From patent issues to the arrival of oncology biosimilars, here is a look at our top 5 podcast episodes from 2019.

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.

The Center for Biosimilars® recaps the top stories for the year 2019.

In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.

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

Given that anti–tumor necrosis factor (anti-TNF) agents are able to suppress mucosal inflammation, some have posited that these drugs could play a role in mitigating immune-related enterocolitis.

This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.

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."

Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.

Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.

AstraZeneca and Daiichi Sankyo said Monday they received FDA approval for their [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu. [Fam-] trastuzumab deruxtecan is an antibody–drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.

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.

It has been hypothesized that metalloproteinases, and particularly MMP3, could a have a role in degrading anti–tumor necrosis factor drugs, leading to treatment failure in patients with inflammatory bowel disease (IBD).

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.

The Center for Biosimilars® recaps the top stories for the week of December 16, 2019.

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

Amgen and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan.

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.

The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.