Authors
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Bevacizumab Biosimilars Reduce Costs While Maintaining Survival Outcomes in mCRCBevacizumab biosimilars Mvasi and Zirabev provided cost savings for metastatic colorectal cancer (mCRC) treatment without compromising effectiveness.
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Opinion: Is the Ophthalmology Market Ready to Embrace Biosimilars?Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.
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Opinion: Purple Book Patent Listings Are Only a First StepIntellectual property attorneys from Axinn discuss the limitations of the Purple Book patent disclosure requirements and the burden these impose on biosimilar developers.
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Biosimilar Nonmedical Switching Must Never Undermine Patient SafetyWhile managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.
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Contributor: Drug Delivery Devices Help Originator Companies Retain Market ShareAmgen's Onpro autoinjector device for pegfilgrastim is a stunning example of how product differentiation via drug delivery devices can protect market share in the biologics market.
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Supportive Care in Oncology Therapy: Pegfilgrastim Biosimilars in the PipelinePegylated version (pegfilgrastim) Neulasta® is the more commonly prescribed agent, with a significantly longer half-life than its predecessor and is the preferred in patients receiving cancer chemotherapy.
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Fourth Ustekinumab Biosimilar, Otulfi, Approved in USOtulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.
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Webinar: Streamlining the Regulatory Process to Advance Access to BiosimilarsThis webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.
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Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name DrugsMedicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.
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Phase 3 Study Confirms Clinical Equivalence for ABP 980 and Reference TrastuzumabComplete phase 3 data show that a biosimilar almost beat reference trastuzumab (Herceptin) for the primary endpoint of pathologic complete response in patients with HER2-positive early breast cancer.
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BioRationality: Commemorating the 15th Anniversary of the BPCIAAffirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
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AAM's Christine Simmon on Biosimilars Council Initiatives and Educating Around InterchangeabilityAfter the Association for Accessible Medicines’ (AAM’s) Access! 2019 annual meeting came to a close last week, The Center for Biosimilars® spoke with Christine Simmon, senior vice president of policy and strategic alliances, AAM, and executive director, AAM’s Biosimilars Council, to get her take on some of the outcomes of the meeting.
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Rituximab Induction Is Cost Effective for Asymptomatic Advanced Follicular LymphomaRituximab induction therapy has the highest probability of cost effectiveness in treating newly diagnosed patients with asymptomatic advanced follicular lymphoma, according to a study published in the British Journal of Haematology.
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Expect Shakeout Amid Biosimilar Market GrowthThe biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.
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Robert F. Kennedy Jr Confirmed as HHS Secretary, Nearly Along Party LinesThe Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.
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Novartis to Make Sandoz a Stand-alone CompanyThe move will create Europe's largest generics company.
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COVID-19's Multifaceted Effect on BiosimilarsThe coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.
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The Role of Biosimilars: Advancing Access, Financial Health, and System SustainabilityKashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.
