Delving into the Latest Updates on Adalimumab biosimilar(Biocad Medical, Inc.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Monoclonal antibody

Synonyms

Adalimumab biosimilar

Target

TNF-α

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

PsoriasisRheumatoid Arthritis

Inactive Indication

Plaque psoriasis

Originator Organization

Biocad Medical, Inc.

Active Organization

Shanghai Pharmaceuticals Holding Co., Ltd.Biocad Medical, Inc.

Inactive Organization

Biocad CJSC

Drug Highest PhaseApproved

First Approval Date

RU (01 Mar 2019),

Psoriasis

Regulation-

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Structure/Sequence

Sequence Code 26792L

The sequence is quoted from: *****

Sequence Code 88699H

The sequence is quoted from: *****

This clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety and tolerability profile of BCD-057 (adalimumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) and Humira when used as a single subcutaneous injection in healthy volunteers.

Start Date01 Jun 2015

Sponsor / Collaborator

Biocad CJSC

100 Clinical Results associated with Adalimumab biosimilar(Biocad Medical, Inc.)

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100 Translational Medicine associated with Adalimumab biosimilar(Biocad Medical, Inc.)

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100 Patents (Medical) associated with Adalimumab biosimilar(Biocad Medical, Inc.)

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5

Literatures (Medical) associated with Adalimumab biosimilar(Biocad Medical, Inc.)

01 Dec 2022·Inflammatory Bowel DiseasesQ2 · MEDICINE

The Sincerest Form of Flattery? Biosimilars in Inflammatory Bowel Disease

Q2 · MEDICINE

Article

Author: Farraye, Francis A ; Limdi, Jimmy K ; Cross, Raymond K ; Bhat, Shubha ; Patil, Seema A

Lay SummaryBiosimilar medications have the potential to significantly reduce the cost of treatment in patients with inflammatory bowel disease. Observational studies have shown similar efficacy and safety of biosimilars to biologic reference products. Shared decision-making is crucial to the successful implementation of these agents.

01 Nov 2019·BiologicalsQ4 · BIOLOGY

Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis – A comparison in a real-world national cohort

Q4 · BIOLOGY

Article

Author: Ionescu, Ruxandra ; Mogoșan, Corina ; Daia, Sânziana ; Enache, Luminița ; Opriș-Belinski, Daniela ; Popescu, Claudiu C ; Codreanu, Cătălin

OBJECTIVEThe study aims to compare the efficacy and safety of biosimilar etanercept (SB4) to original etanercept (ETN) in a real-life national cohort of rheumatoid arthritis (RA).METHODSData from RA patients were retrieved electronically from the Romanian Registry of Rheumatic Diseases (RRBR), which contains all patients receiving biologics in the country.RESULTSThe study included 242 patients with efficacy and safety data after 6 months of treatment: 123 (50.8%) with ETN, 119 (49.2%) with SB4. There were no significant differences after 6 months regarding composite scores of RA activity between patients on ETN and SB4 (e.g. DAS28 remission: 18.7% in ETN group and 17.6% in SB4 group, p = 0.823; Boolean remission: 11.4% in ETN group and 11.8% in SB4 group, p = 0.926). There were 11 adverse events (AE) in the ETN subgroup (including 3 severe AE: lower respiratory tract infection, enterocolitis and anaphylaxis) and 12 AE in SB4 subgroup (including 4 severe AE: lower respiratory tract infection, vasculitis, anaphylaxis and rash).CONCLUSIONBiosimilar and original etanercept showed similar efficacy and safety after the first 6 months of treatment in RA patients from a national registry, which brings further evidence for biosimilarity in unselected patients in real-world setting.

01 Apr 2019·Int. Journal of Clinical Pharmacology and Therapeutics

Comparative efficacy and safety of biosimilar rituximab and originator rituximab in combination with methotrexate in patients with active rheumatoid arthritis: A Bayesian network meta-analysis

Article

Author: Young Ho Lee ; Sang Cheol Bae

OBJECTIVEWe aimed to assess the relative efficacy and safety of biosimilar rituximab and originator rituximab plus methotrexate (MTX) compared to those of placebo plus MTX in patients with active rheumatoid arthritis (RA).MATERIALS AND METHODSWe performed a Bayesian network meta-analysis to combine direct and indirect evidence from randomized controlled trials (RCTs) that examined the efficacy and safety of biosimilar+MTX and rituximab+MTX versus placebo+MTX (MTX group) in patients with active RA despite treatment with MTX and/or tumor necrosis factor (TNF) blockers.RESULTSSix RCTs involving 1,747 patients met inclusion criteria. The American College of Rheumatology 20% (ACR20) response rate was significantly higher in the biosimilar+MTX (odds ratio (OR) 4.30, 95% credible interval (CrI) 1.75 - 10.91) and rituximab+MTX (OR 4.07, 95% CrI 2.51 - 7.18) groups than in the MTX group, with no difference in the ACR20 response rate between the biosimilar+MTX and rituximab+MTX groups. The biosimilar+MTX group had the highest probability of being the best treatment based on the ACR20 response rate (surface under the cumulative ranking curve (SUCRA) = 0.7832), followed by rituximab+MTX (SUCRA = 0.7134) and MTX groups (SUCRA = 0.0034). ACR50 and ACR70 response rates showed a distribution pattern similar to ACR20 response rate. Safety based on number of adverse events did not differ significantly among the three interventions after 24 weeks.CONCLUSIONBiosimilar and originator rituximab, combined with MTX, represent an effective intervention for active RA despite treatment with MTX or TNF blockers. No significant difference was found between biosimilar and originator rituximab regarding efficacy and safety.

100 Deals associated with Adalimumab biosimilar(Biocad Medical, Inc.)

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis	RU	Biocad Medical, Inc.	01 Mar 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Preclinical	CN	Shanghai Pharmaceuticals Holding Co., Ltd.	20 Jul 2022
Plaque psoriasis	Preclinical	RU	Biocad CJSC	01 Dec 2016

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2023	Not Applicable	Arthritis, Psoriatic First line	54	Etanercept originator	(qstmxuxjfm) = jdzicqmsvh feemrgreui (erckedldxm ) View more	-	31 May 2023
				Adalimumab originator	(qstmxuxjfm) = pcplayskbs feemrgreui (erckedldxm ) View more
EULAR2022	Not Applicable	Axial Spondyloarthritis First line	153	Original Adalimumab	(ysprkrwxpu) = agkworlojk uhngouthgz (duibtipsxy )	-	01 Jun 2022
				Biosimilar Adalimumab	(ysprkrwxpu) = cfbyxshjrc uhngouthgz (duibtipsxy )
EULAR2017	Not Applicable	Arthritis TNF-α	200	Biosimilar Adalimumab 40 mg	rdqkkelajz(quzmkneodo) = one patient had developed pulmonary tuberculosis in the 4th month of treatment, biosimilar adalimumab was discontinued and AKT treatment was started nimdgccrac (pudtnaapvt ) View more	Positive	14 Jun 2017
NCT02395055 (CTgov)	Phase 1	-	94	Adalimumab (BCD-057) (BCD-057 Group)	rewyttmimn(yfnucnmdey) = vizsfobbvk vfpewaoged (yovuicvofj, bmopaplcmt - lphuqowviw) View more	-	23 May 2016
				Adalimumab (Humira) (Humira Group)	rewyttmimn(yfnucnmdey) = cuegulstsr vfpewaoged (yovuicvofj, ofncwsosei - iznbhppbzj) View more