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Latest Conference Articles
EU and US Stakeholders Discuss Experience With Switching
Samantha DiGrande
September 6 2018
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.”
More Biosimilar Approvals Are Not Equal to Increased Competition, Stakeholders Say
Samantha DiGrande
September 5 2018
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.
Industry Experts: Naming and Labeling of Biosimilars
Samantha DiGrande
June 27 2018
ACI 11th Summit on Biosimilars & Innovator Biologics
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.
Addressing Concerns Around Interchangeable Biosimilars
Samantha DiGrande
June 26 2018
ACI 11th Summit on Biosimilars & Innovator Biologics
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.
Hot-Button Litigation Issues in the Biosimilar Sphere
Samantha DiGrande
June 26 2018
ACI 11th Summit on Biosimilars & Innovator Biologics
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.
Experts From BIO, PhRMA Deliver Policy and Legislative Updates on Biosimilars
Samantha DiGrande
June 25 2018
ACI 11th Summit on Biosimilars & Innovator Biologics
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.
Low-Dose Biosimilar Rituximab Is Effective in Treating RA
Kelly Davio
June 17 2018
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.
Researchers Present Findings on Biosimilar Adalimumab Products
Samantha DiGrande
June 14 2018
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.