"BioRationality: FDA Needs More Time Before Working With USP on Biosimilars Development" Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility. https://hubs.li/Q03cJVS50
The Center for Biosimilars
图书期刊出版业
Cranbury，NJ 16,872 位关注者
The authoritative resource for emerging therapies.
关于我们
Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.
- 网站
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https://www.centerforbiosimilars.com
The Center for Biosimilars的外部链接
- 所属行业
- 图书期刊出版业
- 规模
- 2-10 人
- 总部
- Cranbury，NJ
- 类型
- 私人持股
- 创立
- 2016
- 领域
- biosimilars、biosimilar news、pharmaceuticals、policy、regulatory和clinical
地点
动态
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Here are what the top 5 biosimilar articles are all about this week! Click the link below to access all of these articles and more! https://hubs.li/Q03cTSKg0
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Celltrion's Omlyclo (omalizumab-igec) is the first omalizumab biosimilar to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor. https://hubs.li/Q03cJW4X0
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On March 6, 2015, the FDA issued its landmark decision to approve the first biosimilar: Sandoz’ filgrastim-sndz, also known as Zarxio. Ten years later, the number of approvals has grown to 67 total biosimilars across 18 originators. The US biosimilars market has seen several ebbs and flows in activity, with many biosimilars taking years to achieve significant collective market share vs their originators. https://hubs.li/Q03chfPH0
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Pharmacists Play a Crucial Role in Adalimumab Biosimilars for Patient Care Adalimumab (Humira; AbbVie) is one of the leading products in the biologics market, often used to treat immune and inflammatory conditions. Unlike other biosimilars, adalimumab biosimilars have unique interchangeability and concentration considerations that impact pharmacy practices. Understanding the availability and considerations surrounding these products is essential—emphasizing the pharmacists’ role in educating patients on their use and workflow. https://hubs.li/Q03chhQx0
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FDA Approves Third Pair of Denosumab Biosimilars The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases. https://bit.ly/3DFd4rw
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No IBD Activity Changes Following Switch From Biosimilar to Originator Infliximab A prospective cohort study found that switching back from the biosimilar SB2 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD). https://bit.ly/3Fm6Z3R
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February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar. https://bit.ly/421WPOy
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Here are what the top 5 biosimilar articles are all about this week! Click the link below to access all of these articles and more! https://hubs.li/Q03bYwbM0
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Bevacizumab Biosimilars Show Similar Efficacy, Safety in NSCLC Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin. https://bit.ly/43EQslq
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