Once Educated, Patients Generally Receptive to Switching to Biosimilars
June 13th 2018At the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, the patient experience with switching to biosimilars from their reference products is a key topic among stakeholders.
Nonmedical Switches Reduce Treatment Costs, Increase Healthcare Utilization
June 13th 2018During the European League Against Rheumatism’s Annual European Congress of Rheumatology, researchers published findings on the economic impacts of nonmedical switching; while 1 study found that switching to biosimilar infliximab brought down costs without sacrificing efficacy or safety, but another raised concerns about increases in overall healthcare utilization.
New Directions in Oncology Biosimilars
June 8th 2018During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.
Research Reports on Rituximab in Treating MCL and DLBCL
June 7th 2018During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).
Real-World Evidence Shows Benefits of On-Body Pegfilgrastim, But Low Use of G-CSF Agents
June 6th 2018Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.
Biosimilar, Follow-On Filgrastim Feature in New Research on FN and Peripheral Stem Cell Mobilization
June 5th 2018Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.
7 Biosimilars Takeaways from ISPOR 2018
May 27th 2018At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers and speakers highlighted emerging trends in biosimilars. Here are 7 key takeaways from the conference.
BBCIC Seeks to Provide Stakeholders With Real-World Data on Biosimilars
May 24th 2018At the International Society for Pharmacoeconomics and Outcomes Research 23rd Annual International Meeting, in Baltimore, Maryland, members of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) discussed the ways in which their organization, a not-for-profit entity that conducts postmarketing observational research to monitor biosimilars and novel biologics for efficacy and safety, is working to provide real-world evidence on these products to stakeholders.
Under Cost Pressure, European Physicians Still Need Education on Biosimilars
May 23rd 2018On Tuesday and Wednesday, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers from Europe addressed the fact that, while biosimilars have a longer history in the European marketplace than they have in the United States, challenges to uptake still linger.
FDA's Mike Blum, MD, MPH, Discusses Postmarketing Surveillance of Biosimilars
May 22nd 2018In a Monday workshop held at the International Society for Pharmacoeconomics and Outcomes Research’s 23rd Annual International Meeting, in Baltimore, Maryland, Mike Blum, MD, MPH, deputy director in the Office of Pharmacovigilance and Epidemiology at FDA, addressed the role of postmarketing surveillance in the US biosimilars market and the potential role of real-world evidence in interchangeable designations for biosimilars.
Research Highlights the Use of Anti-TNF Drugs in Treating RA
May 21st 2018Today, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting, held in Baltimore, Maryland, researchers addressed the complexities of using anti–tumor necrosis factor (anti-TNF) therapy in patients with rheumatoid arthritis (RA).
Panelists Grapple With Healthcare Payment Models and Patient Access
April 20th 2018In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.
Congressman Buddy Carter is "All In" on Biosimilars
April 19th 2018At the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, Earl “Buddy” Carter, Republican Congressman for Georgia’s first legislative district, highlighted his work to control the price of drugs for patients.
Expert Panel Discusses Challenges With Biosimilar Uptake
April 19th 2018A panel of health experts discussed the pathway and speed of biosimilar development, as well as the barriers to major uptake of these drugs, during a discussion at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17.
FDA's Leah Christl Provides an Agency Perspective on the Biosimilars Landscape
April 18th 2018Over time, the United States will see a dramatic increase in the number of biosimilar approvals based on the quantity of applications that the FDA is currently receiving, said Leah Christl, PhD, associate director for therapeutic biologics at the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, at the National Policy and Advocacy Summit on Biologics and Biosimilars held in Washington, DC, on April 17.
Panelists Discuss Roadblocks to Accessing Biologics and Other High-Cost Drugs
April 18th 2018During a panel session at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, panelists discussed key barriers to accessing biologics and other innovative treatments, as well as how patient advocacy can be leveraged to chip away at those barriers.
Savings From Biosimilar Filgrastim Can Expand Access to High-Cost Drugs
December 5th 2017At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).
Argentine-Approved Biosimilar Rituximab Has Similar Safety Profile to Its Reference
December 5th 2017Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.
New Data Support the Use of Tbo-Filgrastim in Pediatric Patients
December 5th 2017On Sunday, December 10, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Noah Federman, MD, will present research from a phase 2 study on the use of subcutaneous tbo-filgrastim (Granix) in pediatric patients with solid tumors who are undergoing chemotherapy.
Financial Incentives May Lead to Overuse of Rituximab Maintenance
December 4th 2017On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.
Originator Biologics Manufacturers "Bi-Vest" in Biosimilars
November 16th 2017Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.
Biosimilar Uptake Hinges on Prescriber, Patient, and Payer
November 16th 2017In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.