Medicines for Europe Experts Discuss EU Market for Biosimilars, Part I
September 28th 2021Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets.
September Roundup: Biosimilar Policy Recommendations, Clinical Developments, and Interviews
September 27th 2021The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.
Kashyap Patel, MD, Highlights the Struggles of Using Pegfilgrastim Biosimilars During the Pandemic
September 26th 2021As COVID-19 cases continue to rise in many states, Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates, provides insight into how biosimilar pegfilgrastims can help reduce costs; however, not all payers are on board.
Cardinal Health Biosimilars Expert Discusses Dynamics of Byooviz Launch
September 24th 2021The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.
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.
Axinn’s Landmon Provides an Expert Legal Opinion on HHS’ Drug Price Strategy
September 22nd 2021The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.
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.
Not So Different: How Biosimilar Companies Are Stepping Up Their Game to Compete Against Originators
September 19th 2021Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.
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.
BIO Attorneys Discuss the BPCIA Patent Dance
September 15th 2021The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.
Samsung Bioepis Reports Long-term Ontruzant Findings for HER2-Positive Breast Cancer
September 14th 2021The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.
ASBM Appoints New Chair in Battle Against Nonmedical Switching
September 14th 2021The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.