A Phase II, Multi-Centre, Double Blind, Randomized, Comparative Study to Evaluate Efficacy and Safety of Etanercept in Patients with Moderate COVID-19 (COVETA) - COVETA

Start Date12 Apr 2021

Sponsor / Collaborator

Lupin Ltd

CTRI/2019/01/016851 / RecruitingPhase 3

Randomized, Controlled Open Label Clinical Study to Compare the Impact of Single Transition from EnbrelÂ® Auto-Injector (AI) to YLB113 AI on Safety, PK and Compare Usability of Both AIs in Patients with Active Rheumatoid Arthritis (RA).

Start Date04 Jan 2019

Sponsor / Collaborator-

CTRI/2016/05/006899 / CompletedPhase 3

A Comparative Study to Assess the Efficacy, Safety and Immunogenicityof YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis

Start Date16 May 2016

Sponsor / Collaborator

YL Biologics Ltd.

100 Clinical Results associated with Etanercept biosimilar(Lupin Ltd)

100 Translational Medicine associated with Etanercept biosimilar(Lupin Ltd)

100 Patents (Medical) associated with Etanercept biosimilar(Lupin Ltd)

Literatures (Medical) associated with Etanercept biosimilar(Lupin Ltd)

01 May 2024·Journal of Orthopaedic Surgery

Efficacy of switching from originator etanercept to biosimilar YLB113 in real-world patients with rheumatoid arthritis: A retrospective 12 months follow-up study

Article

Author: Okamura, Koichi ; Suto, Takahito ; Sakane, Hideo ; Mitomi, Hirofumi ; Inoue, Makoto ; Chikuda, Hirotaka ; Tsuchida, Kosei ; Kaneko, Tetsuya ; Tamura, Yasuyuki ; Yonemoto, Yukio

Purpose: To investigate the disease activity in real-world patients with rheumatoid arthritis (RA) who switched from originator etanercept (ETN) to biosimilar YLB113. Methods: Forty one RA patients who switched from ETN to YLB113 were divided into 2 groups based on the Disease Activity Score based on the 28-joint count (DAS28) 12 months after switching (R group: DAS28 < 2.6, N group: DAS28 ≥ 2.6), and the baseline characteristics were statistically examined. A receiver operating characteristics (ROC) analysis was performed to estimate the cut-off value of DAS28 at baseline to achieve remission 12 months after switching. Results: There was no significant difference in the DAS28 at baseline and 12 months after switching ( p = .83). Sixteen out of the 20 patients in remission at baseline achieved remission after switching. A univariate analysis revealed the rheumatoid factor ( p = .04) and DAS28 ( p < .001) at baseline were significantly lower in the R group than in the N group. Furthermore, logistic regression analysis revealed DAS28 was an independent factor ( p = .004) for achieving remission 12 months after switching. An ROC curve analysis showed the optimal cut-off value for DAS28 at baseline to achieve remission at 12 months after switching was 2.5. Conclusions: RA patients who achieved remission using originator ETN, were able to maintain remission even if they switched to YLB113.

01 Jan 2023·International journal of rheumatic diseases

Lower injection‐site reactions and long‐term safety, immunogenicity, and efficacy of etanercept biosimilar YLB113: Results from a post‐hoc analysis of a double‐blind, randomized, phase III comparative study and its open‐label extension in patients with rheumatoid arthritis

Article

Author: Bakhle, Dhananjay ; Yamanaka, Hisashi ; Hibino, Toshihiko ; Shah, Chirag ; Stefanidis, Dimitris ; Tanaka, Yoshiya ; Unmesh, Gopalakrishnan

Abstract:

Aim:

YLB113 biosimilar was evaluated in an open‐label extension single‐arm study to assess long‐term safety, efficacy, and immunogenicity in patients with rheumatoid arthritis (RA). We also report post‐hoc results on the incidence of injection‐site reactions (ISRs) and injection‐site erythema (ISE) from a phase III study.

Method:

Participants from the phase III, double‐blind, randomized, 96 week equivalence study who completed the final visit received 50 mg YLB113 subcutaneously every 2 weeks. Key safety end points were assessed through adverse events (AEs), ISRs, ISE, and anti‐drug antibody (ADA) incidence. The efficacy end point was change from baseline in Disease Activity Score 28‐joint count (DAS28) over time.

Results:

Of 201 participants, 184 (91.5%) completed the study. Treatment‐emergent AEs were experienced by 93.5% and severe AEs by 10.0% of participants. The discontinuation rate due to AEs was 2.0%. Overall, 20.0% of participants reported an incidence of ISRs throughout the open‐label extension study. Two participants developed ADAs, and none developed neutralizing ADAs at any time after study drug administration. The overall DAS28 (mean ± SD) change was 2.22 ± 0.95 at the study transition, 2.10 ± 0.91 at week 72, and 2.06 ± 0.89 at the end of the study. In the post‐hoc analysis, YLB113 showed a statistically significant lower incidence of ISRs (10 [3.8%], P < 0.0001) and ISE (5 [1.9%], P < 0.0001) compared with the reference product Enbrel®.

Conclusion:

YLB113 demonstrated long‐term safety and sustained efficacy for up to 96 weeks. Patients on YLB113 experienced significantly lower ISRs and ISE in a post‐hoc analysis of the phase III study when compared with reference product.

01 Aug 2020·European journal of drug metabolism and pharmacokineticsQ4 · MEDICINE

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Q4 · MEDICINE

Article

Author: Kshirasagar, Santhosh ; Al-Ghazawi, Ahmad ; Vittala, Praveen ; Al-Jaouni, Rana ; Kasibhatta, Ravi Sekhar ; Bakhle, Dhananjay ; Shennak, Mustafa ; Godse, Neelima

BACKGROUND AND OBJECTIVES:

YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immune-mediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel^®.

METHODS:

Healthy male subjects aged 18-50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods.

RESULTS:

Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the log-transformed pharmacokinetic parameters maximum serum concentration (C_max), area under the serum concentration-time curve (AUC) from 0 to the last measurable concentration (AUC_(0-t)) and AUC from 0 to infinity (AUC_(0-∞)) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatment-emergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively.

CONCLUSIONS:

A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA.

JORDAN FOOD & DRUG ADMINISTRATION UNIQUE TRIAL NUMBER:

31/Clinical/2018.

News (Medical) associated with Etanercept biosimilar(Lupin Ltd)

06 Aug 2024

·pipelinereview.com

Lupin Launches Rymti® Biosimilar Etanercept in Canada

MUMBAI, India | BOUCHERVILLE, Canada I May 03, 2024 I Global pharma major Lupin Limited (Lupin) today announced the launch of Rymti®, Lupin’s first biosimilar in Canada, through its partner Sandoz Canada (Sandoz). Rymti® is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents. Rymti® is approved for all therapeutic indications of the reference product Enbrel®. Etanercept as an established therapy option Lupin’s Etanercept was first approved for the treatment of rheumatoid arthritis by PMDA in 2019, EMA in 2020, Health Canada in 2022, and since then has offered an effective treatment option for several chronic inflammatory diseases. Patient friendly application by means of pre-filled pen Rymti® is available as a solution for injection in a pre-filled pen and pre-filled syringe. Data show a high patient acceptance of the easy-to-handle pre-filled pen. Patients favored this latex-free device for self-injection, which can lead to improvement in compliance. Cost-effective treatment with Rymti® Rymti®, with an equivalent efficacy and safety to reference product Enbrel®, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. The etanercept biosimilar Rymti, produced by Lupin, received approval from Canada’s drug regulator, Health Canada (HC), in August 2022, for all indications of the reference product Enbrel. “We are delighted to announce the launch of Rymti®, Lupin’s first biosimilar in Canada through our partner Sandoz,” said Vinita Gupta, Chief Executive Officer, Lupin . “With this important milestone, we continue to advance healthcare accessibility and affordability for patients in Canada.” “Etanercept is used globally in the fight against a range of severe autoimmune disorders. We are happy to bring etanercept to the patients in Canada. We have diligently worked to build our portfolio to include etanercept ensuring patients have access to effective and affordable equivalent. This launch demonstrates our commitment to fostering healthcare solutions that truly make a difference,” said Dr. Cyrus Karkaria, President Biotechnology, Lupin. Michel Robidoux, President and General Manager, Sandoz Canada said, “The launch of Rymti® is a key milestone for Sandoz Canada. Thanks to our exclusive partnership with Lupin, we’re adding another etanercept option on the Canadian market, increasing access for patients.” About Etanercept Etanercept is an injectable biologic medicine that inhibits the biological activity of Tumor Necrosis Factor (TNF). TNF is a key cytokine involved in the pro-inflammatory cascade in many chronic, immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. Etanercept as a soluble TNF receptor fusion protein specifically binds to TNF and blocks its activity, thereby reducing inflammation and disease symptoms. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector. Please visit www.lupin.com for more information. SOURCE: Lupin

Drug ApprovalBiosimilar

18 Dec 2023

·www.prnewswire.com

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries

10+ Emerging Markets, Japan & ANZ Transition in Final Phase DUBAI, UAE, Dec. 18, 2023 /PRNewswire/ -- Biocon Biologics, a unique, fully integrated, global biosimilars company with a rich portfolio of insulins and monoclonal antibodies, has successfully concluded the integration of the acquired Viatris biosimilars business with the transition of 10+ Emerging Markets and Japan, Australia and New Zealand in the final phase. Continue Reading PFA the banner image (PRNewsfoto/Biocon Biologics Ltd) All Viatris' biosimilars brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim), Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine) and Kirsty® (bAspart) are now part of Biocon Biologics' commercial franchise in Advanced Markets and 80+ Emerging Markets. Most of these products have been developed by Biocon Biologics and are being manufactured at its world-class facilities in India and Malaysia. Biocon Biologics will now have a strong commercial footprint across ~120 countries with a direct presence in the U.S., Canada, Europe and 9 key Emerging Market countries of India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines. "I am very proud and excited that we have successfully completed the integration of the acquired business across 120 countries. The conclusion of this final wave of transition is a significant milestone and marks the beginning of Biocon Biologics' transformation to a fully integrated global company. I congratulate and thank the entire Biocon Biologics team – colleagues, advisors, and partners. This seamless transition, achieved ahead of schedule, is an outcome of relentless focus, untiring efforts and an unwavering commitment to patients and business continuity." - Shreehas Tambe, CEO & Managing Director. "This milestone presents a unique opportunity for our teams to take Brand Biocon Biologics directly to many markets. This self-led business model will take us closer to the patients, MoHs, prescribers and payers. It will allow us to expand affordable access to larger patient pools and generate significant savings for healthcare systems in these emerging markets, thus enabling equitable access to high quality biosimilars." - Susheel Umesh, Chief Commercial Officer - Emerging Markets. Biocon Biologics has made several key leadership appointments, built new capabilities and infrastructure from the ground up and set up dedicated teams to address the growing needs of patients and customers through self-led and partner or distributor-led commercial models to ensure business continuity for patients, prescribers, partners, and healthcare systems. Website: ; Twitter: @BioconBiologics; LinkedIn: Biocon Biologics SOURCE Biocon Biologics Ltd

AcquisitionExecutive ChangeDrug Approval

100 Deals associated with Etanercept biosimilar(Lupin Ltd)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Etanercept biosimilar(Lupin Ltd)	L04AB01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-radiographic axial spondyloarthritis	AU	Lupin Australia Pty Ltd.	01 Oct 2020
Ankylosing Spondylitis	EU	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	IS	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	LI	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	NO	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	EU	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	IS	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	LI	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	NO	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	EU	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	IS	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	LI	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	NO	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	EU	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	IS	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	LI	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	NO	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Plaque psoriasis	EU	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Plaque psoriasis	IS	Biosimilar Collaborations Ireland Ltd.	20 May 2020
Plaque psoriasis	LI	Biosimilar Collaborations Ireland Ltd.	20 May 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


YLB113-002 (EULAR2021)	Phase 3	Injection Site Reaction \| Erythema	-	YLB113	zbeqwmkspj(ayulxptrnl) = yareecjngb mzliuycymm (zsslwzeyeu ) View more	Positive	02 Jun 2021
YLB113-002 (EULAR2021)	Phase 3	Injection Site Reaction \| Erythema	-	Reference Product (RP)	zbeqwmkspj(ayulxptrnl) = ycswwjlylh mzliuycymm (zsslwzeyeu ) View more	Positive	02 Jun 2021
YLB113-003 (EULAR2021)	Not Applicable	-	201	YLB113	gseaeazwjc(adidaxjqpl) = vbqkcmpgii tkjjvlbcga (fugpopdywl ) View more	-	02 Jun 2021
EULAR2019	Phase 3	Rheumatoid Arthritis	528	YLB113	vkijqxltic(znllhnkkzt) = xtupswjgkd kcpiiszhep (wnydoaddnc )	Positive	12 Jun 2019

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