April 29th 2024
The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Review Highlights Biosimilar Epoetin Alfa in Treating Anemia in Myelodysplastic Syndromes
April 23rd 2019Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.
Asian Researchers Report Success With Biosimilars in the Rheumatology Clinic
April 10th 2019During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.
Researchers Present Real-World Data on Biosimilar Infliximab Agents at APLAR-ARA
April 8th 2019This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.
Golimumab Could Save on RA Costs Versus Biosimilar Infliximab, Study Suggests
April 6th 2019Intravenous golimumab and infliximab are both widely used in the treatment of rheumatoid arthritis (RA) in the United States, though these anti–tumor necrosis factor agents have markedly different dosing recommendations; patients who receive golimumab may receive 7 infusions during year 1, while patients who receive infliximab may receive between 8 and 14 infusions during year 1.
Researchers Provide Updates on Benefits of Bevacizumab in NSCLC
April 4th 2019Next week, researchers from around the globe will gather in Geneva, Switzerland, for the 2019 European Lung Cancer Congress. During the meeting, multiple research teams will discuss new findings from research into the use of bevacizumab—which now has approved biosimilars that promise cost savings and expanded patient access—in nonsquamous non–small-cell lung cancer (NSCLC).
Head-to-Head Study Shows CT-P13 Is Noninferior to Reference Infliximab in CD
April 1st 2019Approval of biosimilars in indications for which they were not studied directly in phase 3 clinical trials relies on the extrapolation of indications, a concept that is scientifically justified but, nevertheless, has generated some concerns among clinicians. In the case of biosimilar infliximab CT-P13 (Inflectra, Remsima), some gastroenterologists have voiced a lack of confidence in the biosimilar for the treatment of inflammatory bowel disease, including Crohn disease (CD) and ulcerative colitis. Now, head-to-head study, published in The Lancet, has produced data that may help allay those worries.
Biosimilars Benefit Patients With Expanded Access, but Physicians Still Need Education
March 29th 2019Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.
Reducing the Dose of Anti-TNF Agents Appears Feasible in Spondyloarthritis
March 23rd 2019Recently, a study sought to determine whether dose reductions of anti–tumor necrosis factor (anti-TNF) therapies are possible for long-term treatment of spondyloarthritis, and found that a reduced dose is noninferior to a full dose in patients in sustained clinical remission.
An Expert View on Immunogenicity and Biosimilars
March 22nd 2019During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.
Cellular Response to Infliximab May Be Linked With ADA Development
March 20th 2019Like all biologics, infliximab has the potential for immunogenicity, and the development of antidrug antibodies (ADAs) can lead to loss of response or hypersensitivity reactions. A newly published paper sought to evaluate the development of a cellular response to infliximab and whether such a response could predict ADA development.
Treating MS With Rituximab May Be Safe During Pregnancy and Breastfeeding
March 18th 2019Although rituximab does not carry an indication for the treatment of neurological disorders, the drug is widely used off-label as a therapy for B-cell–mediated disorders like multiple sclerosis (MS). Given the fact that rituximab has not been approved in these indications, however, data that reflect its safety and efficacy—particularly in patient populations for whom data are particularly scarce—are crucial.
Most Patients With AS Stop Their First Anti-TNF Therapy by Year 2, Study Finds
March 14th 2019Recently, a new study sought to examine treatment patterns in US patients new to anti–tumor necrosis factor (anti-TNF) therapy, and it found that a majority of patients, particularly women, do not remain on their first anti-TNF after 2 years.
Biosimilar Filgrastim Shows How Value Can Evolve Over Time, Study Says
March 12th 2019A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.
Fewer Than Half of Oncologists in ESMO Survey Report Using Biosimilars in Clinical Practice
March 11th 2019Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.
Most Polish Pharmacists Have Concerns About Biosimilars, Survey Finds
March 9th 2019Biosimilars have been making substantial inroads in Europe, where their use is associated with increased patient access to treatment, particularly in nations with lower healthcare resources. Even so, biosimilars may be unfamiliar to stakeholders, and prescribers, pharmacists, and patients have lingering concerns about these products.
Investigators Present Data on ADA Development, TDM for Biosimilar Adalimumab
March 6th 2019The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.
Researchers Present Findings on Switching to CT-P13 in IBD
March 4th 2019This week, the European Crohn’s and Colitis Organisation (ECCO) will hold its 14th Congress in Copenhagen, Denmark. During the meeting, which runs from March 6-9, experts will gather from around the globe to discuss significant medical research into the treatment of inflammatory bowel disease (IBD), and numerous researchers will present findings on real-world switches to biosimilar infliximab CT-P13 (Inflectra, Remsima).
Bevacizumab and Cost-Saving Biosimilars Could Play a Role in Treating Advanced HCC
February 22nd 2019A newly published study discussed the potential for the anti–vascular endothelial growth factor agent bevacizumab (Avastin) and its cost-saving biosimilars to be used as second-line therapy for the treatment of patients with advanced hepatocellular carcinoma (HCC) who progressed while receiving standard therapy.
In Treating Patients With IBD Using Anti-TNFs, Clinicians Must Recognize and Manage AEs
February 17th 2019Originator and biosimilar anti–tumor necrosis factor (anti-TNF) therapies are widely used to treat inflammatory bowel disease (IBD) and are effective in reducing systemic inflammation and thereby reducing tissue damage. While these drugs have revolutionized the treatment of IBD, adverse events (AEs) related to these agents can cause morbidity and mortality, and gastroenterologists must be prepared to recognize and manage these AEs. A recently published review described AEs of particular concern with anti-TNFs and outlined their management.
Even as Russian Biosimilars Advance, Providers Have a High Unmet Educational Need
February 15th 2019Even as developers begin work on the next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars.
CT-P13 in IBD Is Safe and Effective in the Long Term, Research Shows
February 14th 2019Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).
New Research Highlights the Role of Biosimilar Etanercept in Treating Ankylosing Spondylitis
February 13th 2019While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).