News

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.

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.

While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.

The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.

While adalimumab and methotrexate are understood to have a synergistic effect, the MUSICA trial sought to evaluate the ideal dose of methotrexate needed in patients who receive combination therapy for rheumatoid arthritis.

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

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

Sandoz has announced that it has received a Complete Response Letter from the FDA for GP2013, its proposed rituximab biosimilar referencing Rituxan.

Formycon and its licensee Bioeq today announced positive interim results for a phase 3 clinical trial of FYB201, a proposed ranibizumab biosimilar referencing Lucentis, which is an anti–vascular endothelial growth factor therapy approved to treat patients with neovascular age-related macular degeneration.

The United States Pharmacopeial Convention (USP) announced that it will not be moving forward with its proposed revisions to drug product monographs for biologic medicines.

Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.