FDA-Approved Biosimilar Products
Drug Name
|
Approval Date
|
More Information
|
|---|---|---|
| Zarxio (Filgrastim-sndz) | March 2015 | Zarxio information Press Release: FDA approves first biosimilar |
| Inflectra (Infliximab-dyyb) | April 2016 | Inflectra information Press Release: FDA approves Inflectra |
| Erelzi (Etanercept-szzs) | August 2016 | Erelzi information Press Release: FDA approves Erelzi |
| Amjevita (Adalimumab -atto) | September 2016 | Amjevita information Press Release: FDA approves Amjevita |
| Renflexis (Infliximab-abda) | May 2017 | Renflexis information |
| Cyltezo (Adalimumab-adbm) | August 2017 | Cyltezo information |
| Mvasi (Bevacizumab-awwb) | September 2017 | Mvasi information Press Release: FDA approves first biosimilar for the treatment of cancer |
| Ogivri (trastuzumab-dkst) | December 2017 | Ogivri information Press Release: FDA approves first biosimilar for the treatment of certain breast and stomach cancers |
| Ixifi (infliximab-qbtx) | December 2017 | Ixifi information |
| Retacrit (epoetin alfa-epbx) | May 2018 | Retacrit information Press Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia |
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Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act.
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act.
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