Samantha DiGrande

The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.

This week, the FDA released a draft guidance document titled “Formal Meetings Between the FDA and Sponsors or Applicants of [Biosimilar User Fee Act] BsUFA Products.” The guidance offers clarification to industry members on the procedures and specifications of formal meetings with the FDA.

Mylan and its partner Biocon have received a Complete Response Letter from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.

This week, the FDA approved an expanded indication of the Janus kinase (JAK) inhibitor tofacitinib (Xeljanz) to include adults with moderate to severe ulcerative colitis. Tofacitinib is the first oral medicine approved for long-term use in UC, and provides an alternative to anti–tumor necrosis factor (anti-TNF) drugs that must be injected or infused.

This week, the Community Oncology Alliance (COA), which represents approximately 5000 community oncologists, announced that it has filed a lawsuit against HHS, HHS Secretary Alex Azar, the Office of Management and Budget (OMB), and the director of the OMB, Mick Mulvaney, in the District of Columbia to stop the departments from applying the Medicare sequester cut to reimbursement for Part B drugs.

Recently, the American Diabetes Association (ADA) released a set of policy recommendations to improve patient access to much-needed insulin and to lower the substantial cost to treat diabetes.

Vizient, a healthcare performance improvement company, recently voiced its concerns to the Office of the United States Trade Representative about proposed tariffs on Chinese products.

In collaboration with the National Heart, Lung, and Blood Institute, researchers from the Perelman School of Medicine at the University of Pennsylvania led a multicenter, randomized, double-blind, placebo-controlled study that compared the effect of adalimumab treatment of moderate to severe psoriasis or phototherapy on vascular inflammation and cardiovascular biomarkers.

Drug maker Lupin announced last week that its marketing authorization application for a proposed etanercept biosimilar, YLB113, was accepted by the European Medicines Agency.

EvaluatePharma recently released its take on the current state of the market for orphan drugs in its Orphan Drug Report for 2018.

In the latest move by Anthem Inc., the company announced earlier this week that it plans to acquire Aspire Health, the nation’s largest non-hospice advanced care provider.

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.

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.

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.

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.

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.

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.

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.

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

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.

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).

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.

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.

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.

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

This week, biosimilar developer Coherus announced that it has resubmitted a Biologics License Application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate referencing Neulasta.

Yesterday, at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom, researchers presented a study that investigated the clinical outcomes of a multi-disciplinary switch to biosimilar etanercept from the reference product in patients with rheumatoid arthritis.

Trastuzumab competition in the European market is heating up, as Mundipharma announced yesterday that it has officially launched Celltrion’s biosimilar, Herzuma.