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Presenters 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.

During 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.

During the first day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, 2 major biosimilar developers gave a look at their strategies for 2019 and beyond.

There are several options for the prophylaxis of febrile neutropenia (FN), including pegfilgrastim delivered in an on-body injector (OBI), a single injection of pegfilgrastim, and daily injections with reference filgrastim or Sandoz’ biosimilar filgrastim.

The 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.

The 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.

For 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.

Celltrion’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.

In 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.

Patients 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.

The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.

A 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.

Being able to switch from a reference product to a biosimilar is important for 3 reasons, explained Hillel Cohen, PhD, executive director of scientific affairs at Sandoz, during his presentation at SMi Biosimilars USA Conference in Iselin, New Jersey, held November 14-15, 2018.

Experts 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.

During 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.

Pegfilgrastim, 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.

Anemia 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.

The 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.

Among 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.

While 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.

While 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.

As more biosimilars are earning regulatory approvals in both the United States and the European Union, the question of whether to switch patients (and at what point to do so) continues to be discussed; researchers will present findings from 2 etanercept switching studies in patients with rheumatoid arthritis (RA) during the American College of Rheumatology’s (ACR) Annual meeting, held in Chicago, Illinois October 19-24, 2018.

With a number of new biosimilars making their way to market and eventually to the clinic, it is crucial that healthcare providers become educated about and comfortable with biosimilar products. During a session at the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom, experts addressed a number of key areas for provider education.

During the American College of Rheumatology’s Annual Meeting, held in Chicago, Illinois from October 19-24, 2018, various researchers will present findings on the safety, efficacy, and immunogenicity of 3 adalimumab biosimilars.

Among the hottest topics in biosimilar development is the future of clinical trials, and that fact was evident during the opening session of the fifth DIA Biosimilars Conference, held October 22 to 23 in London, United Kingdom. During the presentation, a review of the biosimilar regulatory framework, 4 experts explained the ways in which the landscape for clinical trials is evolving for biosimilars.

The potential for the development of antidrug antibodies is a key concern among prescribers who use all biologics that target tumor necrosis factor (TNF). Two presentations at the American College of Rheumatology Annual Meeting in Chicago, Illinois, which will be held from October 19-24, 2018, will address the immunogenicity of biosimilars in patients with rheumatoid arthritis and other inflammatory diseases.

As biosimilar etanercept SB4, sold in many markets as Benepali, has entered the rheumatoid arthritis treatment space, researchers have recognized the need to investigate the retention rates and disease activity scores among patients receiving SB4 and its reference.

Stakeholders hoping to see increased uptake of biosimilars in the United States are increasingly pointing to a lack of provider awareness as a key hindrance to the biosimilars marketplace. New research, to be presented at the American College of Rheumatology Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, suggests that, despite efforts to educate providers, awareness of biosimilars—as well as awareness of patients’ attitudes toward them—remains low.

As more biosimilars are poised to become available to US patients, American rheumatologists are looking to their European counterparts for lessons learned from nonmedical switches from reference products to biosimilars. During the American College of Rheumatology (ACR) Annual Meeting in Chicago, Illinois, held from October 19-24, 2018, several research teams will present on nonmedical switching in the European context.

A review was recently conducted among 2 different types of randomized clinical trials in the treatment of rheumatoid arthritis (RA): those comparing reference biologics’ efficacy versus placebo, and those comparing reference biologics’ efficacy versus biosimilars.