News

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

Sanofi released phase 3 results this week for its long-acting insulin glargine (Toujeo) when used in pediatric patients with type 1 diabetes aged 6 to 17.

Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.

The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.

A recent study from Romania examined the efficacy and safety of biosimilar etanercept SB4 (Benepali) compared to originator etanercept in a real-life cohort of patients with rheumatoid arthritis (RA).

The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.

The biggest cost difference in filgrastim administrations was seen in the commercially insured population after the launch of a biosimilar, according to a study published Monday in Health Affairs.

UnitedHealthcare has revised its community and commercial plans’ coverage of erythropoiesis-stimulating agents. Effective January 1, 2020, patients who are receiving the reference epoetin alfa, Epogen or Procrit, will be required to switch to Pfizer’s biosimilar, Retacrit.

On Friday, President Donald Trump announced that he intends to nominate Stephen Hahn, MD, FASTRO, to be the next FDA commissioner.

In a research letter appearing this week in JAMA Internal Medicine, authors from Oregon Health and Science University raised the question of whether the “large and increasing revenue from eculizumab” could be tied to off-label use for non-approved indications.

Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.

In its third quarter 2019 financial results, AbbVie, maker of the blockbuster Humira, said that its international revenues for the brand-name adalimumab were $1.049 billion, or a decrease of 33.5% on a reported basis, after having faced competition from biosimilars.

The ONWARD study included patients who initiated therapy with the biosimilar, those who switched from the reference infliximab, or those who switched from a different biologic therapy.

The Center for Biosimilars® recaps the top stories for the week of October 28, 2019.

A bipartisan bill introduced in the Senate this week aims to address the growing issue of drug shortages.

This week, during the Academy of Managed Care Pharmacy Nexus 2019 meeting, held in National Harbor, Maryland, healthcare practitioners have gathered to share insights into patient care. Among the groups presenting new findings are 2 research teams that have investigated patterns of use for biosimilar and follow-on products in the United States, and their findings provide insight into how biosimilars are progressing in the US market.

With new research presented this month, and with new biosimilars in the pipeline that target inflammatory bowel disease (IBD), October was a notable month for biosimilars in the gastroenterology space.

Given how markets operate, pharmaceutical companies need financial incentives in order to keep providing a reliable stream of high-quality products that otherwise, due to low prices and other factors, might fall into shortage, according to an FDA report about the drug shortages problem released this week.

The American Society of Clinical Oncology (ASCO) today released its third annual National Cancer Opinion Survey, results of which highlight the added stress that the financial burden of treatment places on patients with cancer.

Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Between 2003 to 2014, patients in Ontario, Canada, received public drug benefits for infliximab or adalimumab at a combined rate of 2.2% in 2003, rising to 18.8% of eligible patients by 2014. During that period, the prevalence of Crohn‐related hospitalizations fell 32.4%.

Albert Bourla, DVM, PhD, Pfizer’s chief executive officer, announced during the company’s third quarter 2019 earnings call that Pfizer has set launch dates for its biosimilar rituximab, Ruxience (referencing Rituxan), and trastuzumab, Trazimera (referencing Herceptin).

This week, clinicians gathered in San Antonio, Texas, for the American College of Gastroenterology (ACG)’s 2019 meeting, where a number of presentations focused on the treatment of inflammatory bowel disease. During the congress, 2 studies presented addressed adverse events (AEs) associated with—one of which was resolved by—the use of biosimilar infliximab, CT-P13 (Inflectra).

Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.

A bipartisan bill to require patent transparency in an effort to bring down the cost of prescription drugs has been introduced in the House of Representatives; the bill is a piece of companion legislation to one introduced in the Senate in March.

Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

Earlier this year, The Center for Biosimilars® staff sat down with our editorial advisory board member, Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center. In the interview, Abraham discussed how biosimilars have progressed in the United States over the past year, whether biosimilars are indeed delivering on their promised cost savings, and challenges that still lie ahead in the cancer space.