News

“Do I think these numbers are reasonable and achievable? Potentially,” said Christina Corridon, MPH, MBA, a principal with the consulting firm ZS.

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

The 2 companies say that they will focus on biosimilars of originator products that will face patent expiry in 2025 to 2030.

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called "biomimics," or copy biologics.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

A bill supported by a coalition of physician specialty organizations was introduced in the House of Representatives this week to alleviate the growing use of prior authorizations in Medicare Advantage. At the same time, the group released survey results saying that PAs are increasing physician burdens and leading to delays in patient care.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

The Center for Biosimilars® recaps the top stories for the week of June 3, 2019.

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.

The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.

The FDA has issued a long-awaited and highly anticipated guidance on establishing analytical testing of biosimilars to a reference product This article summarizes the essential elements of the guidance, and it identifies pivotal changes and recommended study designs.

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.

With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

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.

In May 2019 policy news, bills touching on various aspects of biosimilars progressed through Congress, and HHS finalized 2 proposals affecting drug pricing. One state capped monthly insulin prices, while in Canada, one province will move patients taking reference biologics for rheumatological diseases and diabetes to biosimilars within 6 months.

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

The Biosimilars Forum said this week that if Congress enacted certain changes, the federal government and beneficiaries could save billions of dollars in Medicare Part B.

The Canadian Rheumatology Association (CRA) has issued an update to its position statement on biosimilars. In the document, the CRA says that evidence for the risk/benefit ratio for biosimilars is accruing rapidly, and physicians must demonstrate fiscal responsibility while providing the best care possible to individual patients.

Researchers are reporting switching data from the phase 3 EQUIRA study in patients with rheumatoid arthritis (RA), demonstrating that a single switch from the reference to the biosimilar had no impact on efficacy, safety, or immunogenicity of etanercept.

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.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

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.