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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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Employer Playbook Suggests Strategies for Biosimilar Adoption, Navigating Adalimumab LaunchesA new resource from the National Alliance of Healthcare Purchaser Coalitions aims to help plan sponsors adopt biosimilars into their pharmacy benefit plans.
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Q&A: Patent Attorney Provides Insight Into Biosimilar Legal ChallengesGeoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.
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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: The Do’s and Don’ts of Adding Novelty to Biosimilars DevelopmentIn his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.
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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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Califf Wins Narrow Senate Vote for Second Turn as FDA CommissionerIn a 50-46 vote, the Senate confirmed Robert Califf, MD, as President Biden’s FDA commissioner. The agency has been without a permanent leader for more than a year.
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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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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.
