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News & Publications

Publications

Novel Therapies

M281, Anti-FcRn Antibody 

 

M254, Hyper-sialylated IgG (hsIgG) 

 

M230 (CSL730), Recombinant Fc Multimer

 

Platform Technology

 

Biosimilars and Potentially Interchangeable Biologics

Assessment of Comparative Immunogenicity in Biosimilar Development: Immunogenicity and Pharmacokinetics Following a Single Dose of M923, a Proposed Biosimilar for Reference Adalimumab (HUMIRA®), Compared with US- and EU-Sourced Reference Adalimumab in Healthy Subjects, ACR 2016  View Poster 

A Randomised, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of M923 (a candidate biosimilar of adalimumab), versus US-sourced Humira and EU-sourced Humira in Healthy Subjects, EULAR 2016  View Poster 

Bosques CJ, Collins BE, Meador JW, Sarvaiya H, Murphy JL, Dellorusso G, Bulik DA, Hsu IH, Washburn N, Sipsey SF, Myette JR, Raman R, Shriver Z, Sasisekharan R and Venkataraman G. Chinese hamster ovary cells can produce galactose-α-1, 3-galactose antigens on proteins. 2011. Nat Biotechnol 29(5): 459. Epub 2011 May 6.

 

Complex Generics


Glatopa™ (M356) - Posters

  • Development of the First FDA-Approved MS Generic Disease-modifying Therapy: Glatopa® (glatiramer acetate injection), NASP Annual Meeting, Sep 27, 2016  View Poster 
  • Use of Multiple, High Resolution, Orthogonal Assays for Demonstration of Biological and Immunological Equivalence of Glatopa® and Copaxone® 20 mg/mL, ACTRIMS 2016, Feb 19, 2016  View Poster 
  • Demonstration of Equivalence between Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 9, 2015  View Poster 
  • Comparative Gene Expression Profiling between Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 8, 2015 View Poster 
  • Use of Multiple, High Resolution, Orthogonal Assays for Demonstration of Biological and Immunological Equivalence of Glatopa™ and Copaxone® 20 mg, ECTRIMS 31st Congress, Oct. 8, 2015  View Poster 
  • Demonstration of Equivalence between a Generic (Glatopa™) and Brand Copaxone® (glatiramer acetate injection), American Academy of Neurology's (AAN) 2015 Annual Meeting  View Poster 
  • Comparative Gene Expression Profiling between a Generic (Glatopa™) and Brand Copaxone® (glatiramer acetate injection), American Academy of Neurology's (AAN) 2015 Annual Meeting  View Poster 
  • Comparative Efficacy between a Generic (M356) and Brand Copaxone®(glatiramer acetate injection) in an Animal Model of Multiple Sclerosis, ACRIMS-ECTRIMS 2014  View Poster 

 

Glatopa™ (M356) - Manuscripts

Weinstock-Guttman B, Nair K, Glajch J, et al. Two Decades of glatiramer acetate: From initial discovery to the current development of genericsJournal of the Neurological Sciences 2017; 376:255-259.

Anderson J, Bell C, Bishop J, et al. Demonstration of equivalence of a generic glatiramer acetate (Glatopa™). Journal of the Neurological Sciences 2015;359:24-34.

D’Alessandro JS, Duffner J, Pradines J, et al. Equivalent Gene Expression Profiles between Glatopa™ and Copaxone®. PLoS One. 2015 Oct 16;10(10):e0140299.

 

Other Publications and Programs

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Last Updated 05/11/18