Health Plan Restrictions Likely to Have an Impact on Biosimilars, Orphan Drugs
May 20th 2019Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.
Researchers Present Findings on Patient Preferences, Outcomes With G-CSFs
May 18th 2019During this week’s meeting of the International Society for Pharmacoeconomic and Outcomes Research, held from May 18 to 22 in New Orleans, Louisiana, researchers presented findings on both the patient attitudes toward granulocyte colony-stimulating factor (G-CSF) therapies and their effectiveness in the prophylaxis of febrile neutropenia.
Inside the UK Switch to Biosimilar Adalimumab
May 15th 2019During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.
The Need for and Realities of Biosimilars in Generating Health System Savings
May 15th 2019During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.
Sandoz's Francisco Ballester Discusses Biosimilars in Emerging Markets
May 14th 2019During the inaugural Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, Francisco Ballester, MBA, head of the international region for Sandoz, discussed some of the key considerations that biosimilar developers face in emerging markets with The Center for Biosimilars®.
Experts Share Their Experience of the Global Biosimilars Market
May 14th 2019This week, stakeholders from the legal, business, clinical, and development fields of the biosimilars landscape gathered in Amsterdam, the Netherlands, for the Biosimilars Commercialisation Summit 2019, a meeting dedicated to global issues in biosimilars market access. During the meeting, experts from around the globe discussed their experience with biosimilars and the opportunities and challenges that lie ahead.
Panel Discusses Effort by Administration to Lower Drug Prices
April 13th 2019During the last panel at the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars, panelists discussed some of the administration’s proposals, such as moving Medicare Part B drugs to Part D, a proposal to end protected drug classes in Medicare, and the International Price Index.
How Patient Advocates Engage Payers in Discussing Value
April 11th 2019The theme of the Alliance for Patient Access 4th Annual National Policy and Advocacy Summit on Biologics and Biosimilars meeting was all about value, and panelists from the Aimed Alliance and the Partnership to Advance Cardiovascular Health discussed how they used the concept of value in their discussions with payers.
Uptake of Biosimilars in the US: Good News, Bad News
April 10th 2019At the 4th Annual Policy and Advocacy Summit on Biologics and Biosimilars of the Alliance for Patient Access, speakers discussed the fact that while numerous biosimilars have been approved, most have not reached the market in the United States.
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.
Are We Ready for Tailored Clinical Programs for Biosimilars?
March 29th 2019During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.
European Stakeholders Emphasize Multiwinner Tenders as Key to Competition
March 28th 2019During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a group of experts addressed successes, challenges, and learnings from biosimilar procurement processes.
Fostering Biosimilar Policies for a Sustainable Future
March 28th 2019While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.
Future Biosimilars Will Be a Risky Business, Says Norway's Steinar Madsen, MD
March 25th 2019During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.
Rethinking the Patient Perspective on Biosimilars
March 22nd 2019Often left out of the discussion about switching to biosimilars is the perspective of a particularly key stakeholder group: patients. During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21-22 in Porto, Portugal, Francois-Xavier Frapaise, MD, principal of F.-X. Frapaise Consulting, sought to describe current challenges and emerging solutions in gaining patients’ trust in biosimilars and suggested that biosimilars can be an opportunity to “resuscitate the social contract.”
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.
Global Biosimilars Require Regional Development Approaches
March 21st 2019While much attention is paid to the US and European biosimilars markets and the benefits that biosimilars could accrue for patient access and cost reduction, other large regulatory jurisdictions, including those with limited healthcare resources, could also benefit from these products. However, bringing biosimilars to countries outside of European Medicines Agency (EMA) or FDA authority has its unique challenges.
Regulator Explains How Denmark Has Achieved Its Biosimilar Success
March 21st 2019Nikolai C. Brun, MD, PhD, chief medical officer and director of the division of medical evaluation and biostatistics at the Danish Medicines Agency, shared how his national agency has actively worked to adopt and benefit from biosimilars, and provided a clear reminder of the fact that biosimilar uptake does not occur without concerted effort on the part of stakeholders.
More Than a Decade After the First Biosimilar, the Regulatory Landscape Is Increasingly Complex
March 21st 2019During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.
New Research Assesses Factors That May Impact Adalimumab Therapy in IBD
March 8th 2019During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).
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.
Studies Investigate Drug Survival, Discontinuation of Biologics in IBD
March 5th 2019In patients with ulcerative colitis and Crohn disease, treatment with biologics is often effective, but adverse events or loss of response may lead to discontinuation. Several studies that will be presented at this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, sought to investigate factors related drug survival and discontinuation of biologic therapies for inflammatory bowel disease (IBD).
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).
IQVIA Data Show ANDA Approvals on the Rise, Biosimilars Fighting for Market Share
February 11th 2019During the Association for Accessible Medicines’ Access! 2019 meeting, Doug Long, vice president of industry relations at IQVIA, gave an update about what trends are being identified in the generic and biosimilars markets across the globe.
Stakeholders Debate the Merits of Drug Pricing Legislation
February 7th 2019Addressing the rising cost of drugs in the United States has become a problem that many entities and stakeholders are hoping to solve. From the federal government down to the state level, everyone seems to be taking the problem into their own hands.
According to Azar, "Those Against Biosimilars Are Simply on the Wrong Side of History"
February 7th 2019HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.