Drugs / BI 695501
BI 695501
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | 2017-01-18 | “BI 695501, its adalimumab biosimilar candidate to Humira ® *, has been accepted for regulatory review by the European Medicines Agency (EMA)” prnewswire.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 met primary | ||||||
| Phase 1 | NCT05203289 | Feb → Aug 2022 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT02899338 | Sep 2016 → Feb 2017 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02606903 | Oct 2015 → Sep 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02045979 | Jan → Jun 2014 | — | Boehringer Ingelheim | Completed | Met primary |
| Phase 1 | NCT01505491 | Dec 2011 → Jul 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02636907 | Jan → Jun 2016 | rheumatoid arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT03210259 | Jul 2017 → Apr 2019 | psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02871635 | Sep 2016 → Apr 2019 | Crohn disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02850965 | Aug 2016 → Jan 2018 | psoriasis | Boehringer Ingelheim | Completed | Met primary |
| Phase 3 | NCT02640612 | Jan 2016 → Nov 2017 | rheumatoid arthritis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT02137226 | Jan 2015 → Mar 2016 | rheumatoid arthritis | Boehringer Ingelheim | Completed | Met primary |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-05-01 | Boehringer Ingelheim | Regulatory US FDA approves Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) to treat multiple chronic inflammatory diseases. |
| 2023-05-22 | Boehringer Ingelheim | Regulatory US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo ® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira ® (adalimumab). |
| 2021-10-15 | Boehringer Ingelheim | Regulatory U.S. FDA Approves Cyltezo® (adalimumab-adbm) as First Interchangeable Biosimilar with Humira® prnewswire.com ↗
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo ® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira ® (adalimumab). |
| 2021-04-23 | Boehringer Ingelheim | Results VOLTAIRE-X phase III data in patients with moderate-to-severe chronic plaque psoriasis support interchangeability application prnewswire.com ↗
"We are proud to present the results from Voltaire-X, a landmark study that supports Boehringer Ingelheim's application for interchangeability between Cyltezo® and Humira®," said Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at Boehringer Ingelheim. |
| 2018-09-12 | Boehringer Ingelheim | Results Biosimilar Cyltezo® demonstrates clinical equivalence to Humira® in patients with moderate-to-severe plaque psoriasis prnewswire.com ↗
Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo ® is equivalent to Humira ®* , with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis. |
| 2017-01-18 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim biosimilar candidate to Humira® accepted for EMA and FDA regulatory review prnewswire.com ↗
Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira ® *, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). |
| 2016-10-26 | Boehringer Ingelheim | Results Boehringer Ingelheim's adalimumab biosimilar candidate shows similar efficacy and safety profile to Humira® in pivotal Phase III study prnewswire.com ↗
Boehringer Ingelheim today announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira® and EU approved Humira® (adalimumab)*. |
| 2015-10-28 | Boehringer Ingelheim | Results Boehringer Ingelheim's Biosimilar Candidate Demonstrated Pharmacokinetic Bioequivalence to Adalimumab prnewswire.com ↗
Boehringer Ingelheim today announced results from a Phase I study ( NCT02045979 ) of its biosimilar candidate (BI695501) for adalimumab (AbbVie's Humira®), that demonstrated pharmacokinetic bioequivalence with both the U.S.-licensed and EU-approved reference products. |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BI 695501 | “Pharmacokinetics and Safety of BI 695501” NCT02899338 ↗ |
| Known as | adalimumab-adbm | “the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers.” PMID 38739422 ↗ May 2024 |
| Known as | Cyltezo | “the biosimilar adalimumab-adbm (Cyltezo®), including pharmacokinetic (PK) profiles, immunogenicity, and safety profiles in healthy volunteers.” PMID 38739422 ↗ May 2024 |
| Modality | Monoclonal antibody | “BI 695501 is an FDA-approved biosimilar to adalimumab reference product (RP). VOLTAIRE-X was a randomized clinical trial to assess outcomes with a biosimilar monoclonal antibody” PMID 35934770 ↗ Aug 2022 |
| Route | Subcutaneous | “BI 695501 single s.c injection” NCT01505491 ↗ |