A Phase IV, Randomized, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicenter Clinical Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.

Start Date04 Aug 2022

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

[+1]

EUCTR2022-000695-19-LT / Unknown statusPhase 4

A Phase IV, Randomised, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicentre Clinical Study to Evaluate the Pharmacokonetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira® in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Start Date22 Jul 2022

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

NCT04514796 / CompletedPhase 1

A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Start Date13 Aug 2020

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with Adalimumab-BWWD (Samsung Bioepis)

100 Translational Medicine associated with Adalimumab-BWWD (Samsung Bioepis)

100 Patents (Medical) associated with Adalimumab-BWWD (Samsung Bioepis)

Literatures (Medical) associated with Adalimumab-BWWD (Samsung Bioepis)

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

Long-term real-world evidence of SB5 (adalimumab biosimilar) treatment in patients with moderate-to-severe psoriasis from the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR)

Article

Author: Feldman, Steven R. ; Jung, Hojung ; Egeberg, Alexander ; Jung, Jinah ; Girolomoni, Giampiero ; Puig, Luis ; Lee, Younju

BACKGROUND:

SB5 (adalimumab-bwwd) is an adalimumab biosimilar targeting tumor necrosis factor (TNF) for the treatment of chronic inflammatory diseases, including moderate-to-severe chronic plaque psoriasis.

OBJECTIVES:

To assess the four-year persistence associated with the effectiveness and safety of SB5 in patients with psoriasis in the UK and Ireland.

METHODS:

This prospective study included 1195 SB5-treated patients using British Association of Dermatologists' Biologic Interventions Register (BADBIR) between 01 June 2018 and 31 August 2022. Persistence was defined as the time from biologic therapy initiation to discontinuation and Kaplan-Meier analysis was used to evaluate SB5 discontinuation rates. Cox regression was used to investigate the effect of covariates on the time-to-first-discontinuation of SB5 with the potential covariates.

RESULTS:

SB5 one-, two-, three-, and four-year discontinuation rates were 26.5%, 37.2%, 41.9%, and 43.3%, respectively. Tested covariates such as switching, age, sex, body mass index (BMI), and duration of psoriasis did not significantly affect the discontinuation rate of SB5.

CONCLUSIONS:

Median persistence of SB5 in predominantly bio-naïve psoriasis patients was about 2.5 years in clinical practice. The results suggest that SB5 can be confidently used for patients with psoriasis, offering comparable outcomes to reference adalimumab.

01 Dec 2024·Drugs-Real World Outcomes

Real-World Evidence of Clinical Outcomes of the Use of the Adalimumab Biosimilar SB5 in Rheumatic and Gastrointestinal Immune-Mediated Inflammatory Diseases: 12-Month Data from the PERFUSE Study

Article

Author: Maugars, Yves ; Braithwaite, Ben ; Fumery, Mathurin ; Coury, Fabienne ; Carbonnel, Franck ; Addison, Janet ; Salliot, Carine ; Hateb, Salima ; Flamant, Mathurin ; Bouhnik, Yoram ; Bernardeau, Christophe ; Fautrel, Bruno

BACKGROUND:

There is a need for published data on real-world use of SB5, an adalimumab (ADL) biosimilar approved in Europe in 2017, on the basis of evidence from pre-clinical and analytic data as well as phase I and III clinical studies demonstrating equivalent efficacy and comparable pharmacokinetics, safety and immunogenicity profiles as the reference ADL.

OBJECTIVES:

The purpose of this study was to estimate patient persistence on SB5 at 12 months post-initiation using clinical and healthcare claims data from the French Système National des Données de Santé (national healthcare claims database, SNDS) in addressing data gaps.

METHODS:

PERFUSE is a 12-month, observational, multi-centre cohort study of patients with rheumatic or gastrointestinal immune-mediated inflammatory diseases (IMIDs) who initiated routine SB5 treatment between October 2018 and October 2020, either as their first ADL (naïve) or transitioning from another ADL (switched). Clinical data, including disease activity scores, C-reactive protein levels, and dosing information, were collected as available from patient records captured during routine visits to specialist physicians. Persistence data were supplemented with data from the French national healthcare claims database (SNDS). Analyses of clinical data were descriptive, while persistence was assessed using a Kaplan-Meier survival analysis.

RESULTS:

Overall, 911 patients were included: 507 from rheumatology centres [116 with rheumatoid arthritis (RA), 78 psoriatic arthritis (PsA), and 313 ankylosing spondylitis (AS)] and 404 from gastroenterology centres [316 with Crohn's disease (CD) and 88 ulcerative colitis (UC)]. Among naïve patients, 12-month remission/low activity rates were 58% for RA, 66% for PsA, 59% for AS, 94% for CD, and 85% for UC, increasing significantly from baseline for all indications (p < 0.05). Switched patients' remission rates remained stable between baseline and month 12 (M12) for all indications (p > 0.05). Persistence (95% CI) at M12 among naïve patients was 59% (46.5, 68.8) for RA, 65% (49.7, 77.1) for PsA, 56% (48.3, 62.6) for AS, 70% (63.0, 75.7) for CD, and 42% (30.7, 53.1) for UC, compared to 60% (42.7, 73.7) for RA, 57% (37.3, 72.1) for PsA, 55% (45.8, 64.0) for AS, 63% (53.4, 71.7) for CD, and 56% (27.2, 77.6) for UC among switched patients. No significant differences were observed between naïve and switched patients (p > 0.05). SNDS pairing provided information on 68 of the 132 patients (52%) who were lost to follow-up in the clinical database, of whom 57 (84%) were confirmed persistent at M12 and 11 (16%) non-persistent. Primary treatment failure (naïve patients) and patient decision (switched patients) were the most common reasons stated for treatment discontinuation.

CONCLUSIONS:

SB5 provides clinically effective treatment of both gastrointestinal and rheumatic IMIDs for naïve and switched patients, with no loss of control observed when switching. Persistence was comparable between naïve and switched populations, though the reasons for non-persistence differed.

TRIAL REGISTRY:

Trial registration number: Clinical Trials identifier NCT03662919. Trial registration date: 10 September 2018.

01 Oct 2024·International Journal of Clinical Pharmacy

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS)

Article

Author: Latter, Sue ; Harvey, Justin ; Addison, Janet ; Rahmany, Sohail ; Cummings, Fraser ; Iria, Inês ; Harris, Clare ; Gonçalves, João ; Young, David

BACKGROUND:

Patient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition.

AIM:

The aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5).

METHOD:

iBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24 weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes.

RESULTS:

A total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity.

CONCLUSION:

This study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes.

CLINICAL TRIAL REGISTERED WITH EUDRACT:

Number 2018-004967-30.

News (Medical) associated with Adalimumab-BWWD (Samsung Bioepis)

18 Nov 2024

·pipelinereview.com

Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ

INCHEON, South Korea and CAMBRIDGE, MA, USA I November 18, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea 1,2 (aflibercept), developed and registered by Samsung Bioepis. OPUVIZ, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis. “The EC approval for OPUVIZ represents a major step toward our goal of expanding access to vital biologic therapies for those in need. We will continue working to expand access to our quality-assured, safe and effective biosimilars to improve patient’s quality of life and support sustainability of healthcare systems.” “This approval is an exciting milestone for both patients and healthcare systems in Europe. OPUVIZ has the potential to create a new treatment option for eligible patients, while also easing the burden of costs associated with these retinal conditions,” said Wolfram Schmidt, Head of Europe at Biogen. “We are delighted to continue our partnership with Samsung Bioepis, with the approval of our fifth biosimilar treatment option in Europe.” The EC approval was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 OPUVIZ is the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe and certain other markets. About the SB15 Phase 3 study 3,4 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . References: SOURCE: Samsung Bioepis

Phase 3Clinical ResultDrug ApprovalLicense out/in

07 Oct 2024

·www.prnewswire.com

Prime Therapeutics announces new, cost-effective Humira® biosimilar solutions, offering clients flexibility and choice

EAGAN, Minn., Oct. 7, 2024 /PRNewswire/ -- Prime Therapeutics LLC (Prime) today announced new, cost-effective Humira biosimilar solutions, offering clients continued flexibility and choice, along with financial risk mitigation strategies designed to maintain and promote access to biosimilars for millions of Americans. These new solutions reflect Prime's distinctive conflict-free approach to the prescription drug supply chain model by offering clients access to biosimilar therapies through a broad network of quality specialty pharmacies. Beginning in 2025, Prime will recommend four manufacturers that offer new biosimilar options for plans, including Organon (Hadlima®), Teva (Simlandi®), Sandoz (adalimumab-adaz), and Celltrion (adalimumab-aaty). Plan options will include retaining Humira® in a parity position to biosimilars, biosimilars first, or biosimilars only strategies. All solutions offer clients access to four, low list-price biosimilar options, with net costs as low as $500-600 per 30-day supply. Adding these solutions deliver more options to the market that allow providers, pharmacies and members choice, leading to biosimilar conversion success. Further, Prime's recommended options have robust biosimilar pipelines, demonstrating a long-term investment in success in the market to provide members with stability and access to their necessary therapies. Prime also supports the efforts of biosimilar manufacturers to provide patient support to keep out-of-pocket costs affordable for most commercial members. "As a trusted, truly transparent pharmacy partner, Prime curates the best solutions, customized for our clients' needs," said Dave Schlett, executive vice president and president, PBM solutions at Prime. "When assessing which option to pursue, clients need to consider the existing member impact, as well as the ability to shift drug market shares to ensure that total plan cost objectives and member savings are achieved." Prime is committed to generating savings, simplifying the navigation of the pharmacy benefit and supporting members on their care management journey. About Prime Therapeutics Prime Therapeutics LLC (Prime) is a diversified pharmacy solutions organization. We offer innovative pharmacy benefit management, specialty and medical drug management, and state government solutions to millions of people across the country. At Prime, we're reimagining pharmacy solutions to provide the care we'd want for our loved ones. We challenge the way it's always been done to develop intelligently designed solutions that deliver savings, simplicity and support to help people achieve better health. For more information, visit us at PrimeTherapeutics.com or follow us on LinkedIn. SOURCE Prime Therapeutics LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Biosimilar

24 Sep 2024

·www.fiercepharma.com

Docs discuss sluggish switch to Humira biosimilars, name preferred off-patent options

Spherix Global Insights looked at which biosimilar brands stand to benefit as AbbVie loses access. Spherix Global Insights has provided a different angle on AbbVie’s successful retention of Humira sales in the face of biosimilar competition, polling doctors about forces shaping the market and their preferred off-patent options.AbbVie reported global Humira sales of $2.8 billion in the second quarter. That represented a 29% drop on an operational basis but meant Humira remained a major product more than one year on from the launch of the first biosimilar in the U.S. Spherix surveyed 313 physicians, split roughly evenly between gastroenterologists, rheumatologists and dermatologists, to understand what is happening.Significantly more gastroenterologists than rheumatologists or dermatologists expressed favorable views of biosimilars, Spherix said. Nearly half of gastroenterologists proactively choose to prescribe biosimilar brands, the survey found, but rheumatologists and dermatologists have largely been driven to off-patent options by “external pressures.” Those pressures have intensified slower than some people expected.One rheumatologist said two years ago they would have predicted Humira would only account for 10% of the market by late 2024. Yet, at the time of the survey in April, the rheumatologist wasn’t seeing that split nor encountering any issues when prescribing Humira. Another physician said they felt about 30% of patients were on biosimilars, with the rest staying on Humira. The second physician also expected biosimilars to penetrate the market faster and to face “this whole tsunami of just lots and lots of work and just the sudden shift.” Yet, so far, the shift has “been odd,” the physician said in April, because “it's not every payer and it hasn't been as awful as I thought it would be.”AbbVie expects to “maintain parity access to biosimilars for a significant majority of patient lives this year,” Jeffrey Stewart, the company’s chief commercial officer, said on an earnings call in July. Asked by an analyst about 2025, Stewart said Humira access “will certainly be lower than this year,” but AbbVie expects to maintain parity access for a “meaningful” portion of patients across all channels.Spherix looked at which biosimilar brands stand to benefit as AbbVie loses access. Gastroenterologists still favor Amgen’s Amjevita, the first Humira biosimilar to launch in the U.S., but are gradually increasing their use of unbranded adalimumab, as sold by Sandoz, Boehringer Ingelheim and Biocon, and Samsung Bioepis and Organon’s Hadlima. Physicians in the other specialties are increasingly using Hadlima, too.Specific biosimilar brand usage depends on what is covered by the patient’s insurance. As well as fighting among themselves, biosimilar manufacturers face competition from AbbVie’s Humira successors Skyrizi and Rinvoq. Stewart said AbbVie saw around 20% of patients move to drugs with other mechanisms, such as Skyrizi and Rinvoq, when they lost access to Humira.

BiosimilarPatent ExpirationDrug Approval

100 Deals associated with Adalimumab-BWWD (Samsung Bioepis)

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KEGG	Wiki	ATC	Drug Bank
-	-	L04AB04	DB00051

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyarticular Juvenile Idiopathic Arthritis	US	Samsung Bioepis Co., Ltd.	28 Jun 2024
Enteritis	KR	Samsung Bioepis Co., Ltd.	20 Sep 2017
Spondylometaphyseal Dysplasia, Axial	KR	Samsung Bioepis Co., Ltd.	20 Sep 2017
Ankylosing Spondylitis	EU	Samsung Bioepis Co., Ltd.	24 Aug 2017
Ankylosing Spondylitis	IS	Samsung Bioepis Co., Ltd.	24 Aug 2017
Ankylosing Spondylitis	LI	Samsung Bioepis Co., Ltd.	24 Aug 2017
Ankylosing Spondylitis	NO	Samsung Bioepis Co., Ltd.	24 Aug 2017
Arthritis, Psoriatic	EU	Samsung Bioepis Co., Ltd.	24 Aug 2017
Arthritis, Psoriatic	IS	Samsung Bioepis Co., Ltd.	24 Aug 2017
Arthritis, Psoriatic	LI	Samsung Bioepis Co., Ltd.	24 Aug 2017
Arthritis, Psoriatic	NO	Samsung Bioepis Co., Ltd.	24 Aug 2017
Axial Spondyloarthritis	EU	Samsung Bioepis Co., Ltd.	24 Aug 2017
Axial Spondyloarthritis	IS	Samsung Bioepis Co., Ltd.	24 Aug 2017
Axial Spondyloarthritis	LI	Samsung Bioepis Co., Ltd.	24 Aug 2017
Axial Spondyloarthritis	NO	Samsung Bioepis Co., Ltd.	24 Aug 2017
Chronic large plaque psoriasis	EU	Samsung Bioepis Co., Ltd.	24 Aug 2017
Chronic large plaque psoriasis	IS	Samsung Bioepis Co., Ltd.	24 Aug 2017
Chronic large plaque psoriasis	LI	Samsung Bioepis Co., Ltd.	24 Aug 2017
Chronic large plaque psoriasis	NO	Samsung Bioepis Co., Ltd.	24 Aug 2017
Colitis, Ulcerative	EU	Samsung Bioepis Co., Ltd.	24 Aug 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


BADBIR (EADV2022)	Not Applicable	Psoriasis	-	SB5	uhuwysntwj(pzjdkxslbb) = Common reasons for SB5 discontinuation were inefficacy (10.6%) and adverse events (9.9%) rcmndyulxo (riszljliit ) View more	Positive	07 Sep 2022
PROPER (EULAR2022)	Not Applicable	Arthritis, Psoriatic \| Rheumatoid Arthritis \| Axial Spondyloarthritis	1,000	SB5	jxumetgtzm(gfzoilfbqb) = lviuxeavyd dyxpkrtasq (vvfvgepbog, 11.4) View more	-	01 Jun 2022
EULAR2022	Phase 1	-	188	SB5-HC (40 mg/0.4 mL)	gekjvetwik(tdscqavpbf) = izkpysiiro cktqxgvqoz (jkjiuqeakh, 0.9200.8262 - 1.0239) View more	-	01 Jun 2022
				SB5-LC (40 mg/0.8 mL)	gekjvetwik(tdscqavpbf) = uqspgirxxf cktqxgvqoz (jkjiuqeakh, 0.9840.9126 - 1.0604) View more
NCT02326233 (CTgov)	Phase 1	-	190	Pen of SB5 (Pen of SB5)	ogilwljrll(zfnbrlzvwl) = lhgguwkvab otlhxhwrlb (mcqsrpgsuu, hbxgguddqe - ipbiykphrx) View more	-	18 Mar 2019
				PFS of SB5 (PFS of SB5)	ogilwljrll(zfnbrlzvwl) = xihmqsthdh otlhxhwrlb (mcqsrpgsuu, sxwkrmuslf - iuytflvnxk) View more
NCT02326233 (Pubmed \| Drug Des Devel Ther) Manual	Phase 1	-	95	SB5 (delivered subcutaneously via AI)	wuvbgdrduy(uhxtshkfpe) = For the primary endpoints, the 90% CIs for the ratio of geometric least squares means for SB5 AI to SB5 PFS ranged between 0.9503 and 1.2240, which were all within the equivalence margin of 0.80-1.25 egvfuponle (rcenmelelt )	Negative	05 Nov 2018
				SB5 (delivered subcutaneously PFS)
NCT02144714 (CTgov)	Phase 1	-	189	US sourced Humira®+SB5 (EU Sourced Humira®)	ugtafnupys(gfmslztagi) = vykyterldl aybsiqjdcb (xlyzqxwcrv, dhwrsdrlhl - riuvhwxqxr) View more	-	21 Sep 2018
				EU sourced Humira® (US Sourced Humira®)	ugtafnupys(gfmslztagi) = xsrysakyin aybsiqjdcb (xlyzqxwcrv, gynjkpmkcd - knmhmtkyyn) View more
EULAR2017	Phase 3	-	-	SB5 (Adalimumab Biosimilar)	aaachufjxw(gfsqzzvvob) = jyhrqexcoe upvkcfhkss (szpqvvcimv )	-	14 Jun 2017
				Reference Adalimumab (ADL)	aaachufjxw(gfsqzzvvob) = pgirkhayvy upvkcfhkss (szpqvvcimv )
NCT02167139 (CTgov)	Phase 3	Rheumatoid Arthritis	544	SB5 (proposed biosimilar to adalimumab) (SB5 (Proposed Biosimilar to Adalimumab))	ezngjpnlda(ixujusyrre) = jrnlpciwgn safddxrnvr (bpydysdjpu, crwggvmlwn - msdioimxct) View more	-	19 Jan 2017
				Humira (adalimumab)+SB5 (proposed biosimilar to adalimumab) (Humira (Adalimumab))	ezngjpnlda(ixujusyrre) = ifxdtsvzwf safddxrnvr (bpydysdjpu, nmilylabbi - pjlugecomk) View more
PHASE I PHARMACOKINETIC STUDY (EULAR2015)	Phase 1	-	189	SB5	itkqucoklg(wwjduppgem) = ifgvjoourt ieaxfcdrpp (qhtvzyznwj, 0.885 - 1.108) View more	Positive	10 Jun 2015
				EU-ADL	itkqucoklg(wwjduppgem) = agbhwcvqws ieaxfcdrpp (qhtvzyznwj, 0.904 - 1.131) View more

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