Business

Competition has done little to keep the lid on rising pharmaceutical prices for brand-name products, especially insulins and anti-inflammatory drugs, and costs will continue to rise unless action is taken, according to a recent paper written by researchers from the Scripps Research Translational Institute.

Generic drug maker Lannett Company has announced the beginning of a clinical trial of its proposed biosimilar insulin glargine referencing Lantus.

Last year, when noted researcher James Allison, PhD, won the Nobel Prize for Physiology or Medicine for his pioneering work that led to the development of groundbreaking oncology treatment, he took the occasion as an opportunity to decry what he said was a death of basic scientific research, as development for new pharmaceuticals is usually tied to closely guarded company data.

Ahead of the anticipated 2019 marketing of FDA-approved anticancer biosimilars in the United States, pharmacy benefit manager (PBM) Magellan Rx Management today announced the launch of an oncology biosimilar program.

Prestige BioPharma announced this week that the European Medicines Agency (EMA) has accepted for review its Marketing Authorization Application for a proposed trastuzumab biosimilar, HD201. Prestige hopes to eventually sell the product under the name Tuznue.

The Center for Biosimilars® recaps the top news for the week of May 27, 2019.

The House of Representatives has passed HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), as well as 2 other bills dealing with drug prices: HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, and HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics (BLOCKING) Act of 2019.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.

Key biopharmaceutical markets outside the United States are focusing on drug prices, and the increased use of biosimilars is a key part of their strategy, according to a report from the PwC Health Research Institute.

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.

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.

A recently released analysis from the Kaiser Family Foundation sheds new light on how rising drug prices are impacting patients' out-of-pocket spending on drugs, as well as the budgets of private and public payers.

Eli Lilly and Company announced this week that it has made a lower-cost insulin lispro injection available in pharmacies. The company said that the authorized version carries a list price ($137.35 per vial and $265.20 for a package of 5 pens) that is 50% lower than that of the brand-name Humalog injection.

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

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.

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.

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.

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.

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®.

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

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 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.

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.