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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 …
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FDA clears Lupin bipolar disorder therapy Risperidone with 180-day exclusivity
03 Sep 2025 16:30 GMT
… several complex generics such as Filgrastim, Pegfilgrastim, Etanercept and Albuterol, Risperidone … with smaller needles, and consistent drug concentrations.
According to Lupin, the … limited.
Notably, according to a FDA guidance document a competitive-generic …
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Ten Years of Data Support Safety of Biosimilar Filgrastim for Donor Mobilization
22 Aug 2025 22:25 GMT
… in oncology treatments.
In the US, Sandoz’s biosimilar (filgrastim-sndz, branded … clinical comparability, and the PIONEER trial data (NCT01519700) showing equivalent … biosimilar-approvals
4. FDA approves first biosimilar Zarxio (filgrastim-sndz) from …
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Trump Executive Order to Cover 26 Drugs Critical to Health
19 Aug 2025 22:07 GMT
… drugs that are deemed to be essential and stockpile the active pharmaceutical … SAPIR has identified 86 medicines as being either critical … HIV treatment Biktarvy (bictegravir) from Gilead, and Neupogen (filgrastim) from … of concern to the FDA. But this number …
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Study Highlights Filgrastim Savings Potential With Biosimilars
18 Jul 2025 16:14 GMT
… examined a single drug to treat neutropenia, filgrastim (Neupogen; Amgen), … patients over 6 chemotherapy trials.2 In the study … cost-effective method of treatment that simultaneously increases access … administration of the incorrect medication.
It takes proper …
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FDA’s Published CRLs Deliver Insight Into the Drug Approval Process
16 Jul 2025 17:44 GMT
… drug developer perform an additional adequate, well-controlled, randomized clinical trial … ; filgrastim-ayow), a biosimilar referencing filgrastim ( … Pharmaceuticals receives FDA approval for Lymphir (denileukin diftitox-cxdl) immunotherapy for the treatment …
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Bio-Thera Solutions Announces FDA Accepts Biologics License Application For BAT2506, A Proposed Biosimilar To Simponi®
16 Jul 2025 12:37 GMT
… S. Food and Drug Administration (FDA) has accepted … ).
About Intas Pharmaceuticals
Intas Pharmaceuticals is a pioneer … affordable treatment option, Intas' products like Neukine (filgrastim), … (EU-GMP) certified biotechnology plant located near Ahmedabad, …
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Sunshine Biopharma’s Canadian subsidiary, Nora Pharma launches biosimilar drug, Niopeg
04 Jul 2025 10:53 GMT
… a pharmaceutical company offering and researching life-saving medicines in … to the reference biologic drug Neulasta (Pegfilgrastim). Like … colony-stimulating factor (filgrastim). It is indicated … small molecule for treatment of SARS Coronavirus infections …
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Aurobindo Pharma shares in focus after European Commission nod for cancer drug Dazublys
03 Jul 2025 10:02 GMT
… April 2025 from the European Medicines Agency’s (EMA) … Committee for Medicinal Products for Human Use … reference drug Herceptin.
Dazublys is indicated for the treatment of … Dyrupeg (pegylated filgrastim) in April and Zefylti (filgrastim) in February. …
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Global Chemotherapy-Induced Neutropenia Treatment Market To Reach $0.76 Billion By 2029 With A Growth Rate Of 5.3%
13 Jun 2025 15:33 GMT
… , and expanding oncology drug pipelines. Rising chemotherapy … , Novartis AG, Takeda Pharmaceutical Company Limited, Amgen Inc … treatment market. For example, Coherus BioSciences Inc. received FDA … Factor Therapy G-CSF: Filgrastim, Pegfilgrastim, Lenograstim
3 …