Not So Different: A Podcast from The Center for Biosimilars

In 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 Ric...

It’s widely expected that the United States will see launches of one or both of the FDA-approved 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 biosimi...

Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars; stakeholders have been eager to see whether these products can jumpstart what has been described by some as a sluggish US market for biosimilar products. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space. Christina Corri...

The question of whether anticancer biosimilars will achieve strong uptake in the United States, and whether they will produce much-needed cost savings, is one that has pervaded the conversation about US biosimilars for some time. Shortly after Amgen launched the first 2 such agents, biosimilar trastuzumab and bevacizumab, OneOncology, a group that comprises 4 large community oncology practices and...

In 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.

It's no secret that biosimilars that treat inflammatory diseases have struggled to gain ground in the United States, but given the benefits that biosimilars can offer, some physicians are taking matters into their own hands with concerted efforts to bring biosimilars to the clinic. This week on the podcast, we're speaking with Colin C. Edgerton, MD. He's one of the founding members of Articularis...

In 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. HHS previously said that the rule would counteract incentives behind higher list prices.  Withdrawal of the rule was a discouraging development for many physicians who hoped that the proposal could give reli...

The 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, executiv...

At 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.

Industry 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 their proposals and other policy issues related to biosimilars. Joining us this week are Juliana Reed and Molly Burich. Reed is the vice president corporate affairs, global biosimilar...

While 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 Ha...

Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them. This 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 Biologic...

Amid 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 caught 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 shared his thoughts with us on bio...

The 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. One newly published study reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the...

In a 2-part proposal published on the Health Affairs blog, a team of authors argued that efforts to induce lower prices through competition via biosimilars will inevitably fail. Instead, they write, prices for innovator biologics should be regulated by the US government after patent expiry. This week on the podcast, we’re talking with Mark Trusheim, MS, one of the authors of the proposal. 

Recent 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.

The 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.

Last 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 misi...

This week on the podcast, we're speaking with Civica Rx’s Heather Wall. She’s the organization’s chief commercial officer, and was recently named one of Modern Heatlhcare’s women leaders to watch.

Those 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...

Recently, 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.

2018 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, interviews The Center for Biosimilars’ senior editor, Kelly Davio, about the key developments in biosimilars last year.

This season on the podcast, we’re bringing you the news you need to stay up to date on the key issues facing biosimilars. In this episode, we’ll talk about what’s new in biosimilar regulation.

Recently, Louis Tharp, the cofounder and executive director of the patient advocacy organization the Global Healthy Living Foundation, visited our studios in New Jersey to talk about how high drug costs impact patients with rheumatic diseases, and how biosimilars can be part of the solution. What follows is a portion of our discussion about biologics, biosimilars, and the patient's viewpoint.

Among the great promises of biosimilar therapies is their ability to not only reduce costs for patients and healthcare systems, but to make room in budgets for spending on other high-cost drugs, especially in treating cancer.  This week on “Not So Different,” our guest is Ali McBride, PharmD, MS, BCPS. McBride is pharmacist who serves as the Clinical Coordinator for Hematology and Oncology at The...