Regulators and Drug Makers Call for Greater International Regulatory Alignment
January 31st 2019On the opening day of the Medicines for Europe (MFE) 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, representatives of the generics and biosimilars industry and regulators gathered to discuss the opportunities and challenges posed by the globalization of medicine development and manufacture.
Is It Time for a Global Reference Product for Biosimilars?
January 26th 2019On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.
Managing Risk Can Ensure Biosimilar Rewards, Expert Says
January 24th 2019Despite the challenges inherent in biosimilars, they have a fairly high probability of success, said Edric Engert, managing director of Abraxeolus Consulting, in a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.
Businesses Have a Financial Stake in Promoting Biosimilars, Employer Groups Say
January 24th 2019At a panel discussion at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, representatives of employer groups discussed the role that businesses have in driving the discussion about raising awareness and adoption of biosimilars. Employer groups can help overcome barriers, such as patient fears and misinformation, and create confidence about using biosimilars, speakers said.
Creating and Sustaining Best Practices in Launching Biosimilars
January 24th 2019Before launching into a discussion of what firms need to consider when identifying “best practices” to get a biosimilar up and running in a new market, Mylan’s global commercial head for biologics and insulin gave a quick history lesson about how far the field has come in a keynote address at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.
What's New in Medicare Part B for Biosimilars
January 23rd 2019The current administration in Washington, DC, is one of the most active when it comes to policy and regulation that affects biosimilars, said a presenter who recapped recent changes for the attendees at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.
At J.P. Morgan Healthcare Conference, Mylan, Momenta, and AbbVie Discuss the Role of Biosimilars
January 10th 2019During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, drug makers Mylan and Momenta explained the role that biosimilars will play in their growth, while AbbVie outlined its strategy for managing direct biosimilar competition.
FDA's Scott Gottlieb, MD, Highlights Biosimilars Initiatives in J.P. Morgan Keynote Address
January 9th 2019During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.
J&J and Biogen Discuss Their Biosimilar Strategies at J.P. Morgan Healthcare Conference
January 8th 2019Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.
At the J.P. Morgan Healthcare Conference, Coherus Outlines "Branded Approach" to Biosimilars
January 8th 2019During the second day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, Dennis M. Lanfear, president and CEO of Coherus BioSciences, presented an overview of what he called his company’s “branded approach” to selling its newly launched biosimilar pegfilgrastim, Udenyca.
Biosimilar Beats Subcutaneous Rituximab on Cost Savings in NHL
December 5th 2018The launch of biosimilar rituximab is an eagerly awaited event among US healthcare stakeholders who are cognizant of the high cost of intravenously (IV) administered rituximab in treating non-Hodgkin lymphoma (NHL). At the same time, another innovation in rituximab delivery—a subcutaneously administered rituximab formulation—has the potential to save both cost and time.
CT-P10 Is Similar to Reference Rituximab in Previously Untreated Advanced Follicular Lymphoma
December 4th 2018The study’s authors concluded that, at the median follow-up of 23 months, the data demonstrated comparable progression-free survival, sustained response, and overall survival between both the biosimilar and the reference product.
Tbo-Filgrastim Delivers VHA Cost Savings, but Could a Change of Strategy Do More?
December 4th 2018For health systems like the Veterans Health Administration (VHA), where controlling costs while providing high-quality care is of heightened concern, achieving the best value for money in the prophylaxis of neutropenia can help to control the cost of cancer care.
More Data Underscore the Safety and Efficacy of CT-P10 in Hematological Conditions
December 4th 2018Celltrion’s CT-P10, a biosimilar rituximab that was FDA approved under the brand name Truxima in November 2018, is already in wide use for a host of indications in many regulatory territories. During this week’s 60th Annual Meeting and Exposition of the American Society of Hematology in San Diego, California, multiple research teams are reporting data that underscore the safety and efficacy of CT-P10 in hematological conditions.
Biosimilar Filgrastim Performs in Stem Cell Mobilization
December 3rd 2018In 2016, the Saskatchewan Cancer Agency switched from the brand-name filgrastim, Neupogen, to a biosimilar, Apotex’s Grastofil, for stem cell mobilization prior to autologous stem cell transplants. In a study presented at the American Society of Hematology’s Annual Meeting, researchers sought to determine the safety and efficacy of using a biosimilar for this setting.
Using Biosimilar Filgrastim Does Not Impact Plerixafor Use in Transplantation Candidates
December 2nd 2018Patients who are candidates for hematopoietic stem cell transplantation (AHSCT) require adequate collection of stem cells, and granulocyte colony-stimulating factor agents (G-CSFs) are typically used for stem cell mobilization while plerixafor is used to increase the yield of mobilized stem cells. While the biosimilar filgrastim agent Zarxio has become a more widely used, cost-saving G-CSF option in this context, little research has been conducted on whether the use of the biosimilar rather than its reference, Neupogen, has an impact on plerixafor use in patients undergoing AHSCT.
Celltrion Weighs in on Biosimilar Uptake Challenges in the United States
November 19th 2018A key factor in overcoming barriers to United States market entry is sharing the positive experiences of both healthcare professionals and patients, explained HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare during a presentation at SMi Biosimilars USA Conference in Iselin, NJ, that took place November 14-15, 2018.
Experts Discuss BPCIA Litigation Confusion, Differences Between IPRs and PGRs
November 15th 2018Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.
Can the Biosimilar Market Achieve Long-Term Sustainability?
November 15th 2018During the first day of the SMi Biosimilars Meeting held in Iselin, New Jersey, from November 14-15, 2018, Christina Yunis, global biosimilars market development lead at Pfizer, discussed the sustainability of and challenges seen in the biosimilars market from an industry perspective.
Positive Clinical Trial Results for 2 Proposed Pegfilgrastim Biosimilars
October 25th 2018Pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF) therapy, has become a key product for the prophylaxis and treatment of febrile neutropenia, and biosimilar options have the potential to reduce the high cost of pegfilgrastim therapy. At the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, 2 research teams presented on studies assessing proposed pegfilgrastim biosimilar products.
Biosimilar Epoetin Alfa Improves Both Hemoglobin Levels and Quality of Life
October 25th 2018Anemia is a common complication for patients who are undergoing chemotherapy, and one that has implications for patients’ quality of life, especially with respect to fatigue. During the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, Jérôme Desrame, MD, reported on results of the CIROCO study, which assessed fatigue in patients with chemotherapy-induced anemia who were treated with biosimilar epoetin alfa.
As Reassuring Data on Anticancer Biosimilars Grow, ESMO Ups Its Biosimilar Education
October 24th 2018The European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018, in Munich, Germany, featured multiple presentations on biosimilars in oncology, all of which are contributing to the body of evidence that points to the safety and efficacy of these products. Despite such reassuring data for biosimilars, however, many stakeholders have noted that lack of provider education on biosimilars is holding back progress with uptake.
Lessons Learned From Denmark's Biosimilars Success
October 24th 2018Among European nations, Denmark has had some of the greatest success with leveraging biosimilars to reduce cost burdens on its healthcare system, and during the fifth DIA Biosimilars Conference, held October 22 to 23, 2018, in London, United Kingdom, stakeholders heard directly from Dorthe Bartels, MSc, on how Denmark has achieved its strong biosimilar uptake.
FDA's Leah Christl Provides an Update on the Biosimilar Action Plan
October 23rd 2018While it is indeed the case that the current administration has made drug pricing and biosimilars a priority, and while the Biosimilar Action Plan was hailed as a major step forward for biosimilars in the United States, “It’s not the only plan that’s going to exist,” said the FDA's Leah Christl, PhD.
The Challenge of Educating Patients on Biosimilars
October 23rd 2018While provider education on biosimilars presents a hurdle for health systems worldwide, patient education is also an area of significant need. During the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, several stakeholders addressed this challenge.