Delving into the Latest Updates on Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Adalimumab Biosimilar (Mochida Pharmaceutical Co., Ltd.), LBAL, 阿达木单抗生物类似药（Mochida Pharmaceutical Co., Ltd.）

+ [1]

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [6]

Active Indication

Colitis, UlcerativeUveitis, PosteriorAnkylosing Spondylitis+ [7]

Inactive Indication-

Originator Organization

Mochida Pharmaceutical Co., Ltd.

Active Organization

Mochida Pharmaceutical Co., Ltd.

Inactive Organization

LG Life Sciences Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (23 Mar 2021),

Ankylosing SpondylitisBehcet SyndromeCrohn's disease, active moderate+ [5]

Regulation-

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Structure/Sequence

Sequence Code 26792L

The sequence is quoted from: *****

Sequence Code 88699H

The sequence is quoted from: *****

Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate the Similarity of Efficacy and Safety of LBAL 40mg Subcutaneous Biweekly Injection to Humira® 40mg Subcutaneous Biweekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX

This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBAL compared to Humira® in subjects with active Rheumatoid Arthritis despite Methotrexate therapy.

Start Date13 Apr 2016

Sponsor / Collaborator

LG Life Sciences Ltd.

[+1]

NCT02206867

/ CompletedPhase 1

A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers

To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.

Start Date01 Aug 2014

Sponsor / Collaborator

LG Life Sciences Ltd.

NCT01895764

/ CompletedPhase 4IIT

Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Start Date01 Mar 2013

Sponsor / Collaborator

University Hospitals of Tours

100 Clinical Results associated with Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

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100 Translational Medicine associated with Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

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100 Patents (Medical) associated with Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

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4

Literatures (Medical) associated with Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

01 Nov 2024·Medicine

Improved injection site reactions after switching from adalimumab reference to adalimumab biosimilar LBAL for ulcerative colitis: A case report

Article

Author: Hirakawa, Yudai ; Yoshiura, Masato ; Kikkawa, Nao ; Kakiuchi, Toshihiko

Rationale:Adalimumab (ADA) is an antitumor necrosis factor agent that is used for the treatment of inflammatory bowel disease. However, its cost has resulted in varying degrees of restricted access across global healthcare economies. Biosimilars are agents that contain a similar version of the active substance of an already approved original biologic agent and are intended to be used for the same indication as the reference product. In general, biosimilars follow the originator; therefore, information on its efficacy and safety had been few. Some studies have reported on replacement of the originator with a biosimilar of the same efficacy because of medical reasons.Patient concerns:A 15-year-old girl with steroid-dependent ulcerative colitis that relapsed after vedolizumab was treated with ADA reference. Six weeks after starting ADA reference, her gastrointestinal symptoms had completely resolved, however, immediately after the eighth dose of ADA reference, redness, swelling, and pruritus were noted at the injection site on the left thigh.Diagnosis:Allergic reaction caused by the ADA reference.Intervention:ADA reference was changed to ADA biosimilar LBAL.Outcomes:ADA biosimilar LBAL was continued without any symptoms, such as local swelling, redness, or itching. In addition, there was no deterioration of gastrointestinal symptoms.Lessons:We showed the efficacy and safety of ADA biosimilar LBAL as an alternative to ADA reference, which caused injection site reactions. Changing from ADA reference to ADA biosimilar because of adverse events may be an option that needs careful observation, considering that the originator and the biosimilar are not exactly the same.

04 May 2021·Animal Cells and SystemsQ4 · BIOLOGY

Physicochemical and biological similarity assessment of LBAL, a biosimilar to adalimumab reference product (Humira®)

Q4 · BIOLOGY

ArticleOA

Author: Horiuchi, Takahiko ; Choi, Ilsub ; Kim, Nayoun ; Song, Seonah ; Kwon, O Hwan ; Jeong, Rae Ung ; Lee, Juneok ; Kwon, Joon-Cheol

LBAL was developed as an adalimumab (Humira®) biosimilar using Chinese hamster ovary cell lines. Comparable quality, safety, and efficacy between a biosimilar and its reference product should be ensured for regulatory approval. Here, we present the results of a comprehensive physicochemical and biological characterization between LBAL and Humira®. As physicochemical attributes, primary and higher-order structure, N-glycan profile, and disulfide linkage were investigated. Biological attributes were evaluated by target/receptor binding analysis and in vitro/ex vivo cell-based assays, which are linked to mechanisms of action. As a result, LBAL had the identical amino acid sequence, similar post-translational modifications and N-/C-terminal variants, and comparable primary, secondary, and tertiary structures and disulfide linkage profile. However, some differences in N-glycan profiles were observed. Biological activities, including tumor necrosis factor (TNF) binding, TNF-neutralization, apoptosis, Fc receptor binding, and complement-dependent cytotoxicity, were largely consistent. Despite a slightly lower antibody-dependent cellular cytotoxicity activity in LBAL, this difference was not significant under physiological conditions. 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.

04 May 2017·Expert Opinion on Investigational DrugsQ2 · MEDICINE

A randomized, double-blind, single-dose, two-arm, parallel study comparing pharmacokinetics, immunogenicity and tolerability of branded adalimumab and its biosimilar LBAL in healthy male volunteers

Q2 · MEDICINE

Article

Author: Jang, In-Jin ; Cho, Joo-Youn ; Yoon, Seo Hyun ; Lee, SeungHwan ; Yang, Sung Mo ; Park, Kyoung Ryun ; Yu, Kyung-Sang ; Chung, Hyewon

OBJECTIVESThis study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira®, in healthy volunteers.METHODSA randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs). Tolerability was also evaluated.RESULTSThe PK characteristics of the test and reference drugs were comparable. The GMR (90% CIs) for C_max and AUC_inf of LBAL to Humira were 1.01 (0.92-1.11) and 0.96 (0.83-1.10), respectively, which were within the conventional bioequivalence criteria of 0.80-1.25. No significant differences occurred in the frequency of subjects with anti-adalimumab antibody-positive responses between both drugs. Tolerability profiles including adverse events were also comparable.CONCLUSIONThe PK characteristics of the biosimilar LBAL and the originator Humira were similar. LBAL and Humira did not show significant differences in immunogenicity and both were well tolerated after a single SC injection.

100 Deals associated with Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Colitis, Ulcerative	Japan	Mochida Pharmaceutical Co., Ltd.	06 Jul 2022
Uveitis, Posterior	Japan	Mochida Pharmaceutical Co., Ltd.	16 Feb 2022
Ankylosing Spondylitis	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Behcet Syndrome	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Crohn's disease, active moderate	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Crohn's disease, active severe	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Polyarticular Juvenile Idiopathic Arthritis	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Psoriasis vulgaris	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Pustular psoriasis	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021
Rheumatoid Arthritis	Japan	Mochida Pharmaceutical Co., Ltd.	23 Mar 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Discovery	Japan	LG Life Sciences Ltd.	13 Apr 2016
Rheumatoid Arthritis	Discovery	South Korea	Mochida Pharmaceutical Co., Ltd.	13 Apr 2016
Rheumatoid Arthritis	Discovery	South Korea	LG Life Sciences Ltd.	13 Apr 2016

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Clinical Result

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Adalimumab biosimilar(Mochida Pharmaceutical Co., Ltd.)

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation