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During the American College of Rheumatology 2018 annual meeting, which will be held from October 19-24 in Chicago, Illinois, a variety of researchers will present on real-world data concerning biosimilar infliximab CT-P13.

In the United States, biosimilar launches have been met with disappointment over what many view as too-shallow discounts to reference products’ list prices. However, as Aurelio Arias, a consultant at IQVIA, explained during the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, the substantial savings that the European market has realized with biosimilars are not necessarily reflected in list prices, either.

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

While every biologics manufacturer has its own standards against which it measures a product’s consistency over time, there is an increasing need for harmonization of these in-house standards with a public standard that can serve as a benchmark for the reference product and all biosimilars. This, explained Meenu Wadhwa, PhD, is where World Health Organization (WHO) international standards come in.

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).

In the early days of the market, explained Michael Muenzberg, MD, biosimilar developers had to decide between 2 business models, which he termed a “follow-on model” and a “biogeneric model.” The former involves investing in device design, safety data, and sales and marketing to compete on aspects other than price alone. The latter model, which has not emerged as a dominant option in Europe, is simply to make a product as cheap as possible.

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

Contrary to experience in the United States thus far, Europe has also seen what Marc-Alexander Mahl, MD, describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.

In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, Laura Sim, JD, senior counsel at Amgen, and Vishal Gupta, JD, partner at Steptoe & Johnson LLP, discussed various naming and labeling considerations that stakeholders need to consider for biosimilars.

Although no biosimilar has earned an interchangeable designation by the FDA to date, the distinction could garner more biosimilar uptake. In a presentation during the American Conference Institute’s Summit on Biosimilars, held June 25-27 in New York, New York, various stakeholders discussed how interchangeability is the future of the space.

Isaac Ashkenazi, partner at Paul Hastings LLP; Gregory Morris, PhD, partner and leader of life sciences litigation at Honigman Miller Schwartz and Cohn LLP; and John Molenda, PhD, partner and co-chair of Healthcare & Life Sciences practice at Steptoe & Johnson LLP, discussed current “hot button” litigation issues in the biosimilar sphere during the American Conference Institute’s Summit on Biosimilars, held June 25-27.

At the American Conference Institute (ACI)’s Summit on Biosimilars Conference, held June 25-27 in New York, New York, panelists Crystal Kuntz, vice president of healthcare policy and research at Biotechnology Innovation Organization, and David Korn, vice president of intellectual property and law at Pharmaceutical Research and Manufacturers of America, provided an overview of recent policy and legislative updates in regard to biosimilars.

Biosimilars featured prominently in research presented at the European League Against Rheumatism's Annual European Congress of Rheumatology. Here are 9 key takeaways from the meeting.

Rituximab has previously been shown to be effective at doses of 1000 mg in treating patients with rheumatoid arthritis (RA) who had previously received other biologic agents. Research presented at the European League Against Rheumatism's Annual European Congress of Rheumatology demonstrates that using lower doses of biosimilar rituximab—which may provide a substantial cost savings—is also effective.

At the European League Against Rheumatism Annual European Congress of Rheumatology, researchers presented findings on 3 studies in which patients switched to a biosimilar etanercept molecule from the reference Enbrel.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers presented findings on adalimumab biosimilars, referencing Humira.

At the European League Against Rheumatism (EULAR)'s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers reported on Biocad’s Russian-authorized biosimilar infliximab, BCD-055, and on switches to the widely approved infliximab biosimilar CT-P13 (Inflectra, Remsima).

At the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, the patient experience with switching to biosimilars from their reference products is a key topic among stakeholders.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, researchers published findings on the economic impacts of nonmedical switching; while 1 study found that switching to biosimilar infliximab brought down costs without sacrificing efficacy or safety, but another raised concerns about increases in overall healthcare utilization.

During a session at the 2018 American Society of Clinical Oncology Annual Meeting, held June 1-5 in Chicago, Illinois, researchers gave a glimpse into new directions in oncology biosimilars through providing results on several studies testing the safety, efficacy, and usage of different biosimilars.

During the 2018 American Society of Clinical Oncology Annual Meeting, researchers published new findings on the use of rituximab in mantle cell lymphoma (MCL) as well as the outcomes of patients who relapse early after treatment with rituximab for diffuse large B-cell lymphoma (DLBCL).

The proposed biosimilar, TAB008, under development by TOT Biopharm, was compared with the reference bevacizumab in a randomized, double-blind, single-dose study conducted in 99 healthy adult males.

Clinical practice guidelines recommend the use of granulocyte-colony stimulating factor (G-CSF) therapies, including the long-acting pegfilgrastim (Neulasta), for the prevention of febrile neutropenia in patients receiving myelosuppressive chemotherapy. Real-world data, published in an abstract concurrent with the 2018 American Society of Clinical Oncology Annual Meeting, demonstrate the feasibility of administering pegfilgrastim via an on-body device.

Research published in conjunction with the 2018 American Society of Clinical Oncology Annual Meeting presented new findings on the use granulocyte-colony stimulating factor agents in treating febrile neutropenia (FN) and in peripheral stem cell mobilization.

During the 2018 American Society of Clinical Oncology's Annual Meeting, researchers presented findings on 3 biosimilar trastuzumab products: Samsung Bioepis’ SB3, Agmen’s ABP 980, and Biocad’s Herticad.

At the International Society for Pharmacoeconomics and Outcomes Research’s (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers and speakers highlighted emerging trends in biosimilars. Here are 7 key takeaways from the conference.