News

This week, Drugs published a letter to the editor concerning a systematic literature review that showed a low risk of safety concerns or loss of efficacy after switching from a reference biologic product to a biosimilar. The letter’s authors said that switching is a beneficial topic for exploration but criticized the review for “over-interpretation of the available data.”

Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.

Yesterday, the FDA announced the release of a 5-part video series designed to provide viewers a background of what biosimilar and interchangeable products are, the development and approval process for these products, and the tools and technologies that are used to demonstrate biosimilarity.

More than two-thirds of patients with rheumatoid arthritis (RA) previously naïve to biologic disease-modifying anti-rheumatic drugs had an inadequate response to their first biologic during 1 year of follow up, according to a recent Taiwanese study.

The European Commission (EC) has announced that it is seeking comments on recently proposed clarifications for how the organization will handle duplicate marketing authorizations for biologics.

An Asian study comparing the quality of glycemic control among patients using biosimilar insulin with those using originator insulin found no independent association of biosimilar insulin with differences in indicators of glycemic control—glycated hemoglobin, insulin dosage, or hypoglycemia.

Currently, beyond the evaluation of a patient’s 28-joint disease activity score (DAS28), there are no standard methods to determine whether patients will respond well to dose reduction of anti–tumor necrosis factor therapy.

Specific human leukocyte antigen (HLA) alleles are associated with the formation of anti-drug antibodies to adalimumab in patients with rheumatoid arthritis and hidradenitis suppurativa, potentially causing reduced therapeutic response.

This week, rheumatologists and rheumatology stakeholders from the American College of Rheumatology (ACR) took to Capitol Hill to advocate on pressing issues in rheumatology care, such as the rising costs of treatment and lack of access to care.

One of the main concerns attributed to anti–tumor necrosis factor (anti-TNF) treatment during pregnancy is the ability for the therapy to be transferred to the fetus. Complete immunoglobulin G (IgG) antibodies, both maternal and therapeutic, are delivered to the placenta during pregnancy naturally. This fact is important for patients who are treated with adalimumab, golimumab, and infliximab, which are complete IgG1 anti-TNF antibodies, and therefore transferred easily to the placenta.

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

The nature (positive, neutral, or negative) and level of impact of proposals on the biosimilar market will become clearer over time as the President directs HHS to take immediate action on some proposals, and as HHS takes future action, with feedback, on additional proposals.

The Center for Biosimilars® recaps the top 5 articles for the week of May 14, 2018.

Researchers involved in the Persephone phase 3 randomized clinical trial of 4089 women with HER2-positive early breast cancer found that 6 months of trastuzumab treatment was not inferior to the current standard.

Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.

The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.

This comment period is important for biosimilar stakeholders because the Trump administration's plan has addressed specific efforts being made by the FDA and HHS to improve biosimilar development, approval, education, and access.

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.

Although the benefits of originator infliximab have been deemed to outweigh the potential harm during pregnancy, in a recent observational study, researchers looked to evaluate whether biosimilar infliximab therapy was associated with any new safety risks.

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.

Drug maker Pfenex has announced positive top-line results from a phase 3 study that showed comparable overall profiles between reference teriparatide (Forteo) and Pfenex’s proposed follow-on, PF708, in patients with osteoporosis. Teriparatide, a recombinant human parathyroid hormone, is an anabolic agent that stimulates bone formation.

At the 58th Annual Scientific Meeting of the British Society for Haematology, held from April 16-18, 2018, in Liverpool, United Kingdom, researchers from 2 hospitals reported on the use of biosimilar rituximab in real-world settings.

Mylan’s insulin glargine follow-on, MYL-1501D, referencing Sanofi’s Lantus, is a long-acting human insulin analogue that allows for once-daily basal use in patients with type 1 diabetes. The drug has been authorized for marketing as a biosimilar insulin in the European Union and in Australia under the brand name Semglee.

In an announcement today, Catalent Biologics and Valerius Biopharma revealed that they will be collaborating on the development and manufacturing of Valerius’ biosimilar products.

In an effort to accurately predict an individual patient’s response after starting or tapering an anti–tumor necrosis factor (anti-TNF) agent, researchers from the Netherlands, reporting findings in Rheumatic and Musculoskeletal Diseases, explain that calprotectin has some predictive value for clinical response in patients starting anti-TNF treatment, although it was not predictive of clinical response after tapering.

In treating ankylosing spondylitis, anti–tumor necrosis factor (anti-TNF) drugs produce a response in approximately 60% of patients. For the 40% of patients who do not respond to treatment, previous studies have suggested that patient characteristics, including sex, may play a role.

This week, the Commonwealth Fund released new findings from its Affordable Care Act Tracking Survey. The survey is a nationally representative telephone poll that tracks coverage rates among 19- to 64-year olds.

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

Rituximab has demonstrated utility in treating other autoimmune diseases, and this phase 2, double-blind, randomized, controlled trial compared rituximab with placebo in 57 patients with primary biliary cholangitis (PBC).

The Center for Biosimilars® recaps the top 5 articles for the week of May 7, 2018.