Podcasts

We sat down with Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the AAM, to discuss some of the advocacy changes the organization is looking to advance and their chances of approval.

We sat down with Ha Kung Wong, an intellectual property law attorney and partner at Venable Fitzpatrick in New York and April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, to discuss potential bills to improve biosimilar uptake and their chances for passage.

April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, discussed 2 pieces of legislation that have the potential to address barriers to biosimilar market entry including the Hatch-Waxman Integrity Act and the Stop Stalling Act.

Noelle Sunstrom, CEO and founder of NeuClone, of Redfern, Australia, discusses the company's future US market prospects and its plans to differentiate from other biosimilar developers.

This week on the podcast, we’re speaking with Sang-Jin Pak, MD, the executive vice president of Samsung Bioepis’ Commercial Division.

This week on the podcast, we’re speaking with Sang-Jin Pak, MD, the executive vice president of Samsung Bioepis’ Commercial Division.

This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.

With pharmaceutical spending at record levels, employers are looking for solutions and are hopeful that biosimilars can play a role in controlling costs. On this episode, we speak with representatives of EmployersRX, a new coalition made up of 3 employer groups that are advocating for measures that would provide relief for the largest purchasers of healthcare.

In the past decade of experience with the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation.

When it comes to US biosimilars, 2019 was a busy year for regulatory activity. This week on the podcast, we're rounding up the key developments of the year.

During 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.

With 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.

Just 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.

This week on the podcast, we’re rounding up the top business stories of November 2019.

As 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.

In 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.

In 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.

With 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.

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 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.

It’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?

Among 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.

This 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.

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.

This 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.

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. 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.

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, executive director of the Biosimilars Council.

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 its proposals and other policy issues related to biosimilars.

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 Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.

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 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.