News

Because biosimilars are relatively new to the United States, drug makers pursuing FDA approval for biosimilars seek additional information about the kinds and quantities of evidence that the agency uses to approve these therapies.

The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.

A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.

Patients with ankylosing spondylitis (AS) may benefit from biologic therapies, including anti–tumor necrosis factor (anti-TNF) treatments including adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade or its biosimiars, Inflectra and Renflexis).

German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.

Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.

Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Drug maker Biocon has launched a biosimilar bevacizumab (referenced on Avastin) in India.

Trastuzumab has been used to manage both early and metastatic HER2-postive breast cancer and has significantly improved the survival of these patients and become the standard of care, according to Arlene Chan, MB BS, FRACP, MMed, writing in Chinese Clinical Oncology.

CMS is proposing a change to lower cost-sharing and improve enrollee incentives to choose biosimilars over reference biologics, and to reduce costs to both Medicare Part D enrollees and the Part D program. This objective would be accomplished by revising the definition of generic drug (§ 423.4) to include follow-on biologic products approved under the section 351(k) biosimilar pathway.

Our latest infographic covers 4 key takeaways from the SMi Biosimilars North America 2017 conference.

A new review discusses the systemic treatment of psoriasis and recommends biologics and biosimilars for long-term treatment of psoriasis because of their better tolerability and safety compared with other systemic treatments, which are limited largely by poor tolerability and cumulative toxicity.

A new study, the phase 3 IMpower150, demonstrated Genentech’s atezolizumab (Tecentriq) and innovator bevacizumab (Avastin) plus paclitaxel and carboplatin chemotherapy significantly reduced the risk of disease worsening or death in the treatment of advanced lung cancer.

Health Canada looks to lower the maximum price for drugs, but doing so could delay patient access, warns Montreal Economic Institute.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.

The United Kingdom's National Institute for Health Research (NIHR), part of the National Health Service (NHS), has created a website to educate the public about biosimilar drugs.

This past week, the FDA began the long-awaited process of adding a 4-letter suffix devoid of meaning, to the end of newly approved biologics’ nonproprietary names.

Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,

A retrospective Chinese study of 59 people with brain edema related to metastatic cancer finds that bevacizumab (Avastin) is an effective and relatively safe treatment for brain edema, with a low risk for cerebral hemorrhage.

Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published study in Global Health suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.

A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.

The American College of Rheumatology (ACR) has voiced its approval of CMS’ attempts to lower the cost of drugs under Medicare Part D, but also called on the organization to allow more rheumatologists, including those in small practices, to take part in alternative payment models (APMs).

Swiss drug maker Roche has filed a lawsuit against Pfizer in a Wilmington, Delaware federal court, seeking to block the rival developer from launching a biosimilar trastuzumab in the United States.

A recently unsealed lawsuit alleges that drug maker Eli Lilly illegally worked with Healthstar Communications and VMS Biomarketing to provide free nursing services to induce healthcare providers to prescribe the drug maker’s insulin products Humalog and Humulin.

Amsterdam, Netherlands, has won its bid to become the new home of the European Medicines Agency.

A recent Health Technology Assessment (HTA) report by the United Kingdom’s National Institute for Health and Care Excellence (NICE) concludes that adalimumab, etanercept, and ustekinumab improve the symptoms of psoriasis in children and young people in the short term, but the cost-effectiveness of these medications requires further study.

Samsung Bioepis announced today that it has received the European Commission's (EC) marketing authorization for its biosimilar trastuzumab, SB3, for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. SB3 is the first biosimilar trastuzumab, referenced on Roche’s blockbuster Herceptin, to receive European regulatory approval.

Four recent studies investigated the proposed etanercept biosimilars SB4, LBEC0101, CHS-0214, and GP2015.