Drugs / PB006
PB006
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multiple sclerosis 1 milestone | |||||
| Filed | EU (EMA) | — | multiple sclerosis | 2022-07-14 | “A Marketing Approval Application (MAA) for the proposed biosimilar natalizumab was also accepted by the European Medicines Agency (EMA) on 14 July 2022.” polpharmabiologics.com ↗ “Natalizumab to drugi lek biopodobny z portfolio Polpharma Biologics, dla którego EMA przyjęła wniosek MAA.” polpharmabiologics.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | US (FDA) | — | relapsing-remitting multiple sclerosis, Crohn’s disease | 2022-07-29 | “FDA) has accepted the first-ever Biologics License Application (BLA) for natalizumab” polpharmabiologics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04115488 | Oct 2019 → Aug 2021 | relapsing-remitting multiple sclerosis | Polpharma Biologics S.A. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-08-28 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces FDA approval of Tyruko® – first and only approved biosimilar to Tysabri®* for relapsing forms of multiple sclerosis polpharmabiologics.com ↗
Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars, announced today that the U.S. Food and Drug Administration (FDA) is the first regulatory body worldwide to approve the use of Tyruko ® (natalizumab-sztn) – a new biosimilar for the treatment of relapsing forms of multiple sclerosis (MS). |
| 2023-07-24 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces first-of-a-kind multiple sclerosis biosimilar natalizumab receives positive CHMP opinion polpharmabiologics.com ↗
Polpharma Biologics, an international biotech company dedicated to the development and manufacturing of biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion regarding granting marketing authorization for natalizumab – a first-of-a-kind biosimilar for the treatment of multiple sclerosis. |
| 2022-07-29 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces FDA file acceptance for review of natalizumab, first proposed biosimilar to Tysabri® polpharmabiologics.com ↗
Years of hard work on our proposed biosimilar of Tysabri ®* have culminated in this BLA submission that was accepted for review today by the U.S. FDA. |
| 2022-07-20 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics announces EMA acceptance of Marketing Authorization Application for proposed biosimilar natalizumab polpharmabiologics.com ↗
Przyjęcie wniosku przez EMA oznacza rozpoczęcie weryfikacji złożonej dokumentacji w celu wydania decyzji o dopuszczeniu leku do obrotu w krajach Unii Europejskiej. |
All press releases naming this drug 8 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PB006 | “Proposed biosimilar natalizumab (biosim-NTZ) PB006 is the first biosimilar monoclonal antibody therapy developed for multiple sclerosis (MS) treatment.” PMID 36689214 ↗ Mar 2023 |
| Known as | biosim-NTZ | “Proposed biosimilar natalizumab (biosim-NTZ) PB006 is the first biosimilar monoclonal antibody therapy developed for multiple sclerosis (MS) treatment.” PMID 36689214 ↗ Mar 2023 |
| Known as | natalizumab | “Proposed biosimilar natalizumab (biosim-NTZ) PB006 is the first biosimilar monoclonal antibody therapy developed for multiple sclerosis (MS) treatment.” PMID 36689214 ↗ Mar 2023 |
| Modality | Monoclonal antibody | “Proposed biosimilar natalizumab (biosim-NTZ) PB006 is the first biosimilar monoclonal antibody therapy developed for multiple sclerosis (MS) treatment.” PMID 36689214 ↗ Mar 2023 |