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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.
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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.
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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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Patel: Biosimilar Education Can Be ChallengingKashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.
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Gastroenterologists Want More Evidence on Nonmedical SwitchingAlthough the totality of the evidence is reassuring, the jury is still out on nonmedical switching to biosimilars, according to new study results.
