February 5th 2025
Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Wayne Winegarden, PhD: Why Competition Is Urgently Needed for Enbrel, Humira
December 12th 2021Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.
FDA Official Addresses Unanswered Questions About Interchangeable Biosimilars
November 10th 2021Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.
Polpharma Biologics Executives Discuss Ranibizumab Biosimilar and Other Product Candidates
October 13th 2021The Center for Biosimilars® speaks with Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, about the company's biosimilar pipeline.
Ivo Abraham, PhD, Discusses G-CSF Biosimilars, Such as Neulasta Onpro
October 11th 2021Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlines the current trajectory and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).
Court Dismisses AbbVie's Trade Secret Piracy Case Against Alvotech
October 7th 2021A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.
AAO Reacts to Ranibizumab Biosimilar Approval
September 23rd 2021The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.
Tanvex Presents Positive Findings for Trastuzumab Candidate at ESMO
September 20th 2021Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.
Roundup: Adalimumab Biosimilar Advancements and a Biosimilar Pill
September 17th 2021Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.