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Methods And Formulations Which Allow The Modulation Of Immune Responses Related To The Administration Of A Biopharmaceutical Drug - EP3021833

The patent EP3021833 was granted to Hexal on Mar 30, 2022. The application was originally filed on Jul 21, 2014 under application number EP14744505A. The patent is currently recorded with a legal status of "Patent Maintained As Amended".

EP3021833

HEXAL
Application Number
EP14744505A
Filing Date
Jul 21, 2014
Status
Patent Maintained As Amended
Feb 25, 2022
Grant Date
Mar 30, 2022
External Links
Slate, Register, Google Patents

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MURPHYMar 26, 2019- -

Patent Citations (6) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication Number
INTERNATIONAL-SEARCH-REPORTUS2012237547
INTERNATIONAL-SEARCH-REPORTWO2012089778
INTERNATIONAL-SEARCH-REPORTWO2013011076
OPPOSITIONWO2004016286
OPPOSITIONWO2012065072
OPPOSITIONWO2012089778

Non-Patent Literature (NPL) Citations (15) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference Text
OPPOSITION- ALTEN et al., "Immunogenicity of a proposed adalimumab biosimilar, FKB327, and the reference products in patients with rheumatoid arthritis", Poster presentation in Clinical: Therapy and observation, 14th Congress of ECCO, (20190306), XP055581968
OPPOSITION- "EMA Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use, EMA/CHMP/BMWP/862 89/2010", EMA, (20120524), pages 1 - 10, XP055581943
OPPOSITION- EMA SmPC for Cyltezo@
OPPOSITION- EMA SmPC for Hulio@
OPPOSITION- GENOVESE et al., "Efficacy , safety and immunogenicity in randomized, double-blind (DB) and open-label extension (OL) studies comparing FKB327, an adalimumab biosimilar, with the adalimumab reference product (Humira@; RP) in patients (pts) with active rheumatoid arthritis (RA", ACR/ARHP Annual Meeting, (20170928), XP055581963
OPPOSITION- "Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (EMEA/CHMP/BMWP/14327/2006)", EMEA, (20071213), pages 1 - 18, XP055581938
OPPOSITION- "Humira@ (adalimumab; 50 mg/ml formulation Package Insert", (20020000), XP055405955
OPPOSITION- KATSANOS et al., "Patterns and clinical relevance of antibody responses during adalimumab therapy", Annals of Gastroenterology, (20100000), vol. 23, no. 3, pages 165 - 171, XP055581983
OPPOSITION- Sarah Yim, "FDA Summary Review of Regulatory Action", FDA, (20151115), XP055581980
OPPOSITION- EMI AIKAWA et al., "Immunogenicity of anti-TNFa agents in autoimmune diseases", Clinic Rev Allerg Immunol, (20100000), vol. 38, no. 2-3, pages 82 - 89, XP055017851
OPPOSITION- BARBOSA et al., "Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics", Drug Discovery Today, (20121223), vol. 17, pages 1282 - 1288, XP055581987
OPPOSITION- KAMEOKA et al., "Effect of buffer species on the unfolding and the aggregation of humanized IgG", J Biochem, (20070914), vol. 142, pages 383 - 391, XP055581990
OPPOSITION- PURI et al., "Pharmacokinetics , safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects", British J Clin Pharmacol, (20170000), vol. 83, pages 1405 - 1415, XP055581957
OPPOSITION- COHEN et al., "Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the Phase III randomised VOLTAIRE-RA equivalence study", Ann Rheum Dis, (20180000), vol. 77, pages 914 - 921, XP055581951
OPPOSITION- ROSENBERG, "Effects of protein aggregates: an immunologic perspective", The AAPS Journal, (20060000), vol. 8, no. 3, pages E501 - E507, XP036197980

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