News

Net spending on biologics totaled $125.5 billion in last year, up 9.5% since 2017. Biosimilar spending has doubled since 2017 but still represents under 2% of the total US biologics market. Biosimilars are used less than one-third of the time, a recent report from IQVIA said.

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 Center for Biosimilars® recaps the top news for the week of May 13, 2019.

With the expanded use of step therapy on the horizon in 2020, an advocacy initiative of rheumatology, arthritis, and gastroenterology and other associations recently released a report “grading” payers and pharmacy benefit managers (PBMs) for the extent of their prescription coverage of medications for patients with autoimmune disorders.

NeuClone announced yesterday that it will initiate a phase 1 clinical trial of its ustekinumab biosimilar, referencing Stelara, in the second half of 2019. Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

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

The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

AbbVie announced today that it has settled its patent litigation with Boehringer Ingelheim over adalimumab.

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 guidance explains that the data and information needed to meet the legal standard for interchangeability, which shows that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in any given patient, will vary by case.

In 2018, The Generic Biosimilar Medicines Association (GBMA) was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan. Now, the GBMA has launched an educational hub.

Discussion related to these products has changed dramatically from those had in previous years; in the past, the industry was discussing the regulatory framework and how the different regulatory agencies, from Mexico to Argentina, would regulate these new therapeutic options. Now, after the maturity of the laws and the construction of different regulatory pathways for biosimilars in most of the countries, the discussion has moved on to the different challenges that the industry, whether local or foreign, faces in commercializing biosimilars.

Biosimilar developer Biocon said this week that it will share in the global profits of Hulio, an adalimumab biosimilar referencing Humira, that is licensed to Mylan by Fujifilm Kyowa Kirin Biologics.

Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.

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.

The Center for Biosimilars® recaps the top news for the week of May 6, 2019.

A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.

China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.

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.

A study designed to see if infliximab could reduce depression symptoms did not show statistically significant results, except for participants who had a history of childhood physical abuse.

In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.

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.

The idea of giving the Federal Trade Commission (FTC) more authority to cut through patent thickets blocking biosimilar competition was raised Tuesday during a hearing of the Senate Judiciary Committee about intellectual property, patent law, and the impact on drug prices.

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.

With additional biosimilars expected to reach the market later this year and beyond, Canada has made another move to foster biosimilar adoption with 2 recent developments.

Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.