News

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.

Drug manufacturer Alexion has announced positive topline results of a phase 3 study that determined that ALXN1210, a long-acting C5 complement inhibitor, can be safely and effectively switched among patients with paroxysmal nocturnal hemoglobinuria currently being treated with the shorter-acting eculizumab (Soliris).

Filgrastim, used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy, is the first drug in the United States to have a biosimilar approved. While the biosimilar filgrastim was approved in 2015, few studies have compared the real-world incidence of FN, healthcare resource utilization, and costs among US patients using the reference product (Neupogen) and those using the approved biosimilar (Zarxio).

During a session at the Academy of Managed Care Pharmacy’s (AMCP) Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26 in Boston, Massachusetts, Reginia Benjamin, BS, JD, director of legislative affairs for AMCP, provided an in-depth look at state legislation on biosimilars.

April was a notable month for regulatory action on biosimilars in the United States, and for regulatory developments in Europe.

While systemic inflammation is a potential biological mechanism underlying both Parkinson disease (PD) and inflammatory bowel disease (IBD), clinical data on comorbid PD and IBD are few. In a new study published in JAMA Neurology, researchers report on a retrospective cohort study that assessed the incidence of PD among patients with IBD and sought to identify whether anti–tumor necrosis factor (anti-TNF) therapy for IBD alters the risk of PD.

At the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting, held April 23 to 26, in Boston, Massachusetts, several research teams presented posters relevant to the US adoption of biosimilars.

The Alliance for Patient Access Annual National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, 2018, explored policies impacting prescribing and patient access to biologic and biosimilar therapies. Here are 7 memorable quotes from the presenters.

While injectable drugs, including some innovator anti–tumor necrosis factor inhibitors and their biosimilars, have revolutionized the treatment of rheumatic diseases like rheumatoid arthritis (RA), hand disability can limit the ability of patients with RA to use syringes to administer medication. Prefilled, disposable auto-injectors may help to alleviate this issue and have demonstrated acceptability studies, but questions have remained about whether patients with reduced manual dexterity may still experience needle displacement when using these devices.

This week, Frost & Sullivan—a global researching and consulting organization—together with Rani Therapeutics, a drug manufacturer developing an approach to the oral delivery of large-molecule drugs, announced the results of a combined research study. The study suggested that biosimilar developers could gain market share from brand-name biologics by developing the biosimilars in oral form.

The Center for Biosimilars® recaps the top 5 articles for the week of April 23, 2018.

The American College of Rheumatology (ACR) told CMS in a letter this week that short-term, limited-duration insurance plans could reduce or restrict access to crucial care for people living with rheumatic diseases.

Retinal vein occlusion (RVO) is a prevalent, vision-threatening disease, of which macular edema is a common complication. Standard treatment for RVO-associated macular edema involves intravitreal treatment with anti–vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab, bevacizumab, or aflibercept. Despite success with these agents in clinical trials, anti-VEGF agents may be administered less frequently in clinical practice than in studies.

Jeffrey Capello, executive vice president and chief financial officer, divulged that Biogen intends to exercise its option to increase its stake in the Samsung Bioepis joint venture. Currently, Samsung BioLogics holds 94.6% of the company, and Biogen owns the remaining 5.4%.