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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: Entering a New Era of Affordable Biosimilar DevelopmentBiosimilar development costs could plummet from $100 million to $5 million, enabling smaller companies to enter the market and revolutionize access to essential medicines.
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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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Low Biosimilar Awareness in MS Patients Points to Critical Gap in Nurse-Led EducationItalian study finds most MS patients start biosimilars unaware, exposing education gaps and highlighting MS nurses as key to boosting trust and uptake.
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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.
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Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque PsoriasisA phase 3 clinical trial found that the ustekinumab biosimilar CT-P43 demonstrated equivalent efficacy, safety, and immunogenicity to reference ustekinumab in patients with moderate to severe plaque psoriasis.
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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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Coherus Banks on 2022 Approvals After Net Losses for Q4, 2021Coherus released its earnings report for the last quarter of 2021 and for the year as a whole.
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Dr Marcus H. Snow: The US Launch of RenflexisMarcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses the recent launch of a new biosimilar infliximab, Renflexis, in the United States.
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FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, HyrimozBoth the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
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Ritumixab Biosimilar Demonstrates Positive Results in Rheumatoid ArthritisPharmacokinetics of CT-P10 were highly similar to originator products.
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Legal Opinion: BPCIA Is Likely to Survive Latest ACA ChallengeIntellectual property attorneys discuss the Supreme Court oral arguments over the Affordable Care Act (ACA) and implications for the Biologics Price Competition and Innovation Act (BPCIA).
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What's Ahead for Biosimilar Litigation?What is ahead for biosimilar litigation? We highlight a recent interview Goodwin partners gave recently about their new guide to biosimilar litigation.
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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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Naming Biosimilars: The Debate Rages OnAs one of Shakespeare’s most famous characters asked, "What’s in a name?”, the answer in the biosimilars industry is clear: nomenclature is critical for identification purposes.
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Study Finds ABP 215 and Bevacizumab Demonstrate PK Similarity in Japanese MenThe researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.
