Adalimumab BS MA (adalimumab biosimilar) News

|||||||||| Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Clinical, P3 data, Journal: Comparison of the efficacy and safety of LBAL, a candidate adalimumab biosimilar, and adalimumab reference product in patients with active rheumatoid arthritis inadequately responding to methotrexate: a 52-week phase III randomised study. (Pubmed Central) - May 20, 2022
LBAL was equivalent in efficacy and comparable in safety, including immunogenicity, to ADL. Switching from ADL to LBAL did not impact on efficacy and safety.

|||||||||| Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Journal: Physicochemical and biological similarity assessment of LBAL, a biosimilar to adalimumab reference product (Humira®). (Pubmed Central) - Jul 16, 2021
As indicated, this extensive analytical characterization and functional comparison assessment showed that LBAL was similar to Humira®, with minor differences of no clinical relevance. Taken together, our comparative assessment of physicochemical and biological attributes demonstrated that LBAL is structurally and functionally very similar to Humira®, supporting the biosimilarity of clinical efficacy and safety.

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Trial completion:  A Study Comparing LBAL to Humira (clinicaltrials.gov) -  Mar 15, 2021
P3, N=383, Completed,  Sponsor: LG Life Sciences
Taken together, our comparative assessment of physicochemical and biological attributes demonstrated that LBAL is structurally and functionally very similar to Humira®, supporting the biosimilarity of clinical efficacy and safety. Active, not recruiting --> Completed

|||||||||| LBAL (adalimumab biosimilar) / Mochida, LG Chem
Clinical and laboratory features of Mycobacterium avium complex infection in comparison with infection, caused by Mycobacterium tuberculosis, in HIV-infected patients (TP-37) - Aug 26, 2019 - Abstract #ERS2019ERS_4881;
MGM/CL for MAC was positive from: blood, urine and feces - 5 patients (including 3 in combination with sputum and liquid bronchoalveolar lavage (S/LBAL)) - 1st group , S/LBAL solely - 4 patients - 2nd group...8 (53%) were febrile Conclusion. Febrile HIV late presenters should be suspected for "the septic form" of MAC disease; blood, urine and feces being obligatory tested by MGM/CL

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Enrollment closed:  A Study Comparing LBAL to Humira (clinicaltrials.gov) -  Feb 8, 2017
P3, N=380, Active, not recruiting,  Sponsor: LG Life Sciences
Febrile HIV late presenters should be suspected for "the septic form" of MAC disease; blood, urine and feces being obligatory tested by MGM/CL Recruiting --> Active, not recruiting

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Enrollment open:  A Study Comparing LBAL to Humira (clinicaltrials.gov) -  May 20, 2016
P3, N=380, Recruiting,  Sponsor: LG Life Sciences
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
New P3 trial:  A Study Comparing LBAL to Humira (clinicaltrials.gov) -  Apr 21, 2016
P3, N=380, Not yet recruiting,  Sponsor: LG Life Sciences

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
Trial completion:  Pharmacokinetics and Safety Study of LBAL in Healthy Subjects (clinicaltrials.gov) -  Jun 15, 2015
P1, N=116, Completed,  Sponsor: LG Life Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Completed

||||||||||  Adalimumab BS MA (adalimumab biosimilar) / Mochida, LG Chem
New P1 trial:  Pharmacokinetics and Safety Study of LBAL in Healthy Subjects (clinicaltrials.gov) -  Aug 1, 2014
P1, N=116, Not yet recruiting,  Sponsor: LG Life Sciences



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