"Not So Different": At the American College of Rheumatology, a UK Perspective on Biosimilars
December 22nd 2019During the American College of Rheumatology’s recent 2019 annual meeting, we caught up with Paul Emery, MD, FRCP, MA, FMedSci. Emery is the Versus Arthritis Professor of Rheumatology, University of Leeds, and the Director of the Leeds Musculoskeletal Biomedical Research Centre at Leeds Teaching Hospitals Trust in the United Kingdom. In this episode of the podcast, we’re sharing highlights of our interview with Emery about biosimilars.
"Not So Different": AmerisourceBergen's Sean McGowan Takes a Closer Look at US Biosimilar Launches
December 15th 2019With us on the podcast to talk about recent and upcoming biosimilar launches is Sean McGowan, senior director of biosimilars at AmerisourceBergen. McGowen spoke with us about what the US biosimilars market needs now in order to thrive and tells us which developments he’ll be watching closely in 2020.
"Not So Different": Celltrion Breaks New Ground With a Subcutaneous Biosimilar Infliximab
December 8th 2019Just last month, the European Commission authorized a subcutaneously administered formulation of biosimilar infliximab CT-P13 for the treatment of rheumatoid arthritis. When the drug launches in the European Union, it will be first infliximab to be available in a subcutaneous formulation. This week on the podcast, we’re speaking about this new product with Mike An, head of the sales and operations division at Celltrion Healthcare.
"Not So Different": Is There a Role for Biosimilars in Value-Based Models?
November 24th 2019As fee-for-service models give way to value-based healthcare delivery models, US providers and patients alike can hopefully look forward to lower healthcare costs, increased quality of care, and improved outcomes. But what role will biosimilars have to play in value-based care? This week on the podcast, we’re speaking with Jeffrey Scott, MD, chief medical officer of Integra Connect, about this issue.
"Not So Different": HealthyWomen Wants to Educate US Women About Biosimilars
November 17th 2019In October of this year, the nonprofit organization HealthyWomen, a group that seeks to educate women to make informed choices about their health, hosted its first Biosimilars and Women’s Health Science and Policy Forum. The daylong forum offered expert perspectives on the state of biosimilars in the United States, legislative and regulatory updates, and a look at challenges and opportunities for biosimilars to improve women’s access to treatment. This week on the podcast, we’re speaking with one of the presenters from that meeting, Lisa Kennedy Sheldon, PhD, APRN, AOCNP, FAAN.
"Not So Different": AARP Says High Prescription Drug Prices Will Impact All Americans
November 10th 2019In September, AARP issued its latest Rx Price Watch report, which tracks price trends for prescription drugs that are widely used by older Americans. That report highlighted the problem of skyrocketing drug costs; it found that the retail prices for widely used drugs increased well above the rate of inflation, and that’s a troubling trend for Medicare beneficiaries. This week on the podcast, we’re speaking with one of the authors of that report, Leigh Purvis, MPA.
"Not So Different": What's New in Biosimilars in Gastroenterology
November 3rd 2019With new research being presented, and with new biosimilars in the pipeline that target inflammatory bowel disease, October was a notable month for biosimilars in the gastroenterology space. This week on the podcast, we’re rounding up the top developments in gastroenterology for the month of October 2019.
"Not So Different": Strategies for Biosimilar Developers in a Litigious US Landscape
October 27th 2019In August of this year, the US District Court for the District of New Jersey ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi. As a result of that decision, biosimilar etanercept appears to be on a lengthy hold in the US market, and that has a number of biosimilar stakeholders concerned. This week on the podcast, we’re speaking with Rick Lozano, vice president of Biosimilars and Integrated Business Development for AmerisourceBergen. We discuss the ruling in the case, its potential impacts on the healthcare system, and what drug makers can do now to help educate other stakeholders about biosimilars and improve uptake.
"Not So Different": Are We Ready for Biosimilar Rituximab in the United States?
October 20th 2019It’s widely expected that the United States will see launches of one or both of the FDA-approved rituximab biosimilars, Ruxience and Truxima, in the coming months, but just how ready is the United States to bring these products to the clinic, especially given the fact that subcutaneously administered reference rituximab has taken on such a key place in clinical practice, and given the fact that both biosimilars have so-called “skinny labels” because of issues related to intellectual property and exclusivities?
"Not So Different": What Have We Learned So Far About US Oncology Biosimilars?
October 13th 2019Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space. Christina Corridon, MPH, MBA, is a principal at the professional services firm ZS Associates, where she is a leader in ZS' oncology practice and leads their biosimilars vertical. She joined us to talk about the state of play in the US biosimilars market, what we can learn from ongoing experience, and how sustainable the US market for biosimilars may be today.
"Not So Different": OneOncology Gives a Closer Look at Its Biosimilar Adoption
September 29th 2019This week on the podcast, we’re speaking with Jeffrey Patton, MD, chief executive officer of Tennessee Oncology, a partner practice of OneOncology, and the president of physician services for OneOncology. Patton shares with us the rationale for the adoption of biosimilars, how patients are responding, and lessons learned.
"Not So Different": Where Are We Headed With Oncology Biosimilars? Vizient Weighs In
September 15th 2019In its semiannual drug pricing forecast, healthcare performance company Vizient said that biosimilars will be a key part of combatting rising spending on drugs. This week on the podcast, we're speaking with Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient, on how oncology biosimilars are poised to make an impact.
"Not So Different": How a Value-Based Pathway Led to Increased Biosimilar Use
September 1st 2019This week on the podcast, we're speaking with Colin C. Edgerton, MD. He's one of the founding members of Articularis Healthcare Group, which has created a value-based rheumatoid arthritis treatment pathway that has boosted biosimilar use.
"Not So Different": What's Next for Drug Pricing After Withdrawal of the Rebate Rule?
August 18th 2019In July, the Trump administration withdrew its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations. Withdrawal of the rule was a discouraging development for many physicians who hoped that the proposal could give relief to their patients at the pharmacy counter. This week on the podcast, we’re speaking to one such physician, Madelaine Feldman, MD.
"Not So Different": The Biosimilars Council Says Patent Abuses Are Costing Biosimilar Savings
August 4th 2019The Biosimilars Council, a part of the Association for Accessible Medicines, recently issued a white paper in which it condemns abuses of the patent system that delay biosimilar competition. The group estimates that the financial impact of these delays has cost the US healthcare system $7.5 billion in lost savings since 2015. This week on the podcast, we’re speaking with Christine Simmon, executive director of the Biosimilars Council.
"Not So Different": What Did the First Half of 2019 Hold for Biosimilars?
July 21st 2019At the beginning of this year, we spoke with Laura Joszt, associate editorial director and the host of The American Journal of Managed Care’s podcast, Managed Care Cast, about where biosimilars stood at the end of 2018. Now, halfway through the year, we’re continuing that conversation with a look at how biosimilars have fared so far in 2019.
"Not So Different": The Biosimilars Forum Wants to Save the Healthcare System Billions
July 7th 2019Industry group the Biosimilars Forum recently put forth 3 policy proposals that it says could save the US healthcare system billions of dollars. This week on the podcast, we’ve invited the forum to tell us more about its proposals and other policy issues related to biosimilars.
"Not So Different": What's Holding Back Biosimilars? It May Not Be Pay-for-Delay Deals
June 23rd 2019While pay-for-delay issues have been big news on Capitol Hill recently, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.
"Not So Different:" A Regulatory Attorney Shares His Take on Interchangeability
June 9th 2019This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.
"Not So Different": A Look Ahead to Biosimilar Insulin
May 26th 2019Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we catch up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shares his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.
"Not So Different": A Look at Biosimilar Education Among European Oncologists
May 12th 2019The cost of cancer care is on the rise worldwide, and biosimilars present one option for bringing down costs. However, those savings depend on adoption and use of biosimilars, and hesitancy to use these agents on the part of prescribers has been well documented in the literature. One newly published study reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the 2017 ESMO Congress in Madrid, Spain, concerning biosimilars. This week, we’re speaking with the study’s lead author, Rosa Giuliani, MD.
"Not So Different": Is It Time to Give Up on Biosimilars?
April 28th 2019It’s no secret that the biosimilars market in the United States has been off to a sluggish start. In fact, former FDA Commissioner Scott Gottlieb, MD, went so far as to call the market anemic. While many stakeholders have called for steps like more education or greater regulatory clarity, a new option has been raised in recent weeks, and that’s doing away with the US biosimilars market altogether.
"Not So Different": Drug Pricing in the United States: a Conversation with Robin Feldman
April 14th 2019Recent months have seen a variety of proposals to bring down the cost of prescription drugs, but will any of them have staying power? This week, senior editor Allison Inserro speaks with Robin Feldman, professor at the University of California, Hastings, College of the Law, and author of the new book Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices.
"Not So Different:" The Community Oncology Perspective on Drug Pricing Proposals and Biosimilars
March 31st 2019The recent weeks and months have seen a number of policy proposals from the Trump administration that impact community oncologists. On this week's podcast, Laura Joszt, associate editorial director of The Center for Biosimilars®, caught up with Ted Okon, MBA, executive director of the Community Oncology Alliance.
"Not So Different:" Addressing Misinformation on Biosimilars
March 24th 2019Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.
"Not So Different:" Meet the Nonprofit Taking on Generic Drug Shortages
March 10th 2019In January of last year, several hospital groups, representing approximately 450 US hospitals, revealed plans to form a nonprofit generic drug company in a bold move designed to address generic drug shortages and high prices affecting their hospitals.
"Not So Different:" The Supreme Court and US Biosimilars
February 23rd 2019Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business. One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.
"Not So Different:" Where Do We Stand With Provider Education on Biosimilars?
February 10th 2019Recently, a new systematic review evaluating US and European provider awareness of biosimilars found a persistent lack of education on both sides of the Atlantic. This week, The Center for Biosimilars® is speaking with Sonia T. Oskouei, PharmD, one of the authors of the review, about the findings.
"Not So Different:" How Biosimilars Advanced in 2018
January 26th 2019Last year was a banner year for biosimilars, both in the United States and abroad. In this episode of the podcast, Laura Joszt, associate editorial director of The American Journal of Managed Care®, the parent publication of The Center for Biosimilars®, interviews senior editor, Kelly Davio, about the key developments in biosimilars last year.