News

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.

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

Earlier this week, Amneal Pharmaceuticals and Impax Laboratories announced the completion of their merger. The newly formed company will be named Amneal Pharmaceuticals, led by Robert Stewart as president and CEO. The finalization of the merger makes Amneal the fifth largest generic drug maker in the United States.

Today, Australian drug developer NeuClone announced positive preclinical results of its proposed ustekinumab biosimilar referencing Stelara. Ustekinumab is a monoclonal antibody that targets interleukin-12 and -23, and the reference product is approved to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

Last week, the FDA announced that it will withdraw a direct final rule that proposed to amend general biologics regulations related to time of inspection requirements and to remove some duties of inspector requirements. In its statement withdrawing the rule, the FDA indicated that it had received significant adverse comments related to its proposal.

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

Antibodies that deplete B cells, including rituximab, have demonstrated efficacy in the treatment of neurological conditions such as progressive multiple sclerosis and neuromyelitis optica spectrum disorder. The efficacy of these treatments hinges on adequate B-cell depletion, but there is a lack of standardization in treatment and monitoring protocols to guide clinical practice.

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today.

Though the use of biosimilars is becoming more common in the adult arthritis space, there has been little research on their use in pediatric patients. Identifying the need for further analysis in this population, researchers conducted a study investigating biosimilar use in children and young adults with juvenile idiopathic arthritis (JIA). The results were presented last week at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom.

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.

Last week, the European Medicines Agency (EMA) released a report describing its contributions to science, medicines, and health for the year 2017.

Some cervical cancer patients with advanced or recurrent disease suffer from anaphylaxis after taxane- or platinum-based therapy, and there is no standard treatment for progressive disease that develops during or shortly after platinum-based chemotherapy. Doctors and patients have therefore sought the development of a non-taxane, non-platinum regimen for recurrent cervical cancer.

The researchers found that the majority of publications on biosimilars came from high-income countries, led by the United States.