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<![CDATA[The FDA proposes ditching comparative efficacy studies for biosimilars]]>
20 Dec 2025 02:25 GMT
… have to conduct clinical trials comparing their biosimilar … drug spending as of 2024, according to an FDA factsheet. Medicare and Medicaid … a comparative efficacy trial].”
Since the FDA’s 2015 publication … the approval of Zarxio (filgrastim-sndz) — the first …
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Kidney Cancer Drugs Market to Reach $10.31 Billion by 2029 with 4.8% CAGR
10 Dec 2025 19:45 GMT
… modification of treatments, enhancement of treatment outcomes through personalised medicine, funding for … in order to diversify treatment options, boost patient access … Amneal Pharmaceuticals Inc. This drug, which is a biosimilar to Neupogen (filgrastim) …
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<![CDATA[FDA Approves Pegfilgrastim-unne for Nonmyeloid Cancers, Febrile Neutropenia]]>
02 Dec 2025 04:49 GMT
… undergoing treatment with myelosuppressive anticancer drugs linked … more affordable, accessible medicines to US patients. … filgrastim, a proposed pegfilgrastim biosimilar, for the treatment … FDA approves Lupin’s Armlupeg injection. News release. Pharmaceutical …
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<![CDATA[Chemoradiotherapy Regimen May Show Viability in Recurrent HNSCC]]>
04 Jan 2026 17:24 GMT
… 2 NRG Oncology RTOG 9911 trial (NCT00005087) published in … a viable option for treatment and potential long-term … NRG Oncology RTOG 9610 trial. Secondary end points included … 1434
Paclitaxel, cisplatin, and filgrastim combined with radiation therapy in …
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While FDA Streamlines Biosimilar Approvals, Patents And Reimbursement Impede Access
03 Nov 2025 13:27 GMT
… the FDA approves biosimilars based on trials showing … effective treatment alternatives to branded reference biologic drugs … Biosimilars
According to Pharmaceutical Technology, the primary … originator biologic, Neupogen (filgrastim), used to treat neutropenia …
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US biosimilar norms to keep local drug cos in good health
30 Oct 2025 20:51 GMT
… biologic drugs-could be a big boost for Indian biotech … for most comparative efficacy trials-the costliest and slowest … introduced its first biosimilar filgrastim in the US market … general of industry body Indian Pharmaceutical Alliance (IPA), said, …
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Human medicines European public assessment report (EPAR): Vivlipeg, pegfilgrastim, Date of authorisation: 18/08/2025, Status: Authorised
02 Oct 2025 14:28 GMT
… by a doctor who has experience in the treatment of … stimulating factor (G-CSF). Filgrastim works by encouraging the … treating neutropenia. In Vivlipeg, filgrastim has been ‘pegylated’ (attached … removal of filgrastim from the body, allowing the medicine to …
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Kashiv Biosciences Announces Submission of Biologics License Application to U.S. FDA and Acceptance of Market Authorization Application by European Medicines Agency for ADL-018, a Proposed Biosimilar to XOLAIR® (omalizumab)
07 Oct 2025 08:49 GMT
… Food and Drug Administration (FDA), and the European Medicines Agency (EMA … indicated for the treatment of moderate to … which already includes RELEUKO® (filgrastim-ayow) and FYLNETRA® … Officer, Affordable Medicines at Amneal Pharmaceuticals. “We are …
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Top 5 Most-Read Biosimilar News of 2025
31 Dec 2025 22:13 GMT
… FDA granted its landmark decision to approve the first biosimilar, Sandoz’ filgrastim … to enhance transparency in Medicare drug price negotiations and … prioritize high-cost drugs. Accelerating biosimilar approval … by phase 3 trial data confirming its …
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Drug Makers And Payers To Blame For Biosimilar Barriers In U.S. Market
04 Sep 2025 21:01 GMT
… available in the filgrastim class of drugs, used to help … cost of expensive biologic medicines. However, biosimilars continue … incentives sometimes pervade the pharmaceutical supply chain.
Competitive markets … 2025. Others have been FDA-approved but aren’t …