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

26 Mar 2019

·www.biospace.com

Obtainment of Manufacturing and Sales Approval for Etanercept Biosimilar, Anti-rheumatoid Arthritis Agent

YL Biolologics Ltd., Yoshindo Inc. and Teijin Ltd. have announced that on March 26, 2019, YL Biologics obtained manufacturing and sales approval for Etanercept biosimilar, an agent for anti-rheumatoid arthritis and polyarticular-course juvenile idiopathic arthritis which YL Biologics has developed globally. YL Biolologics Ltd. (Head office: Chuo-ku, Tokyo, President and Representative Director: Toshihiko Hibino), Yoshindo Inc. (Head Office: Toyama City, Toyama, President and Representative Director: Hiroki Kitamura) and Teijin Ltd. (Head office: Kita-ku, Osaka, President and CEO: Jun Suzuki) have announced that on March 26, 2019, YL Biologics obtained manufacturing and sales approval for Etanercept biosimilar, an agent for anti-rheumatoid arthritis and polyarticular-course juvenile idiopathic arthritis (Development code: YLB113) which YL Biologics has developed globally. YL Biologics has led the global phase III study enrolled over 500 Rheumatoid Arthritis patients and a half of them were recruited in Japan. Based on the results of phase III study, YL Biologics submitted NDA to MHLW in March, 2018. Although YL Biologics obtains active pharmaceutical ingredients of YLB113 from Lupin Ltd., an India based global pharmaceutical company, YL Biologics subcontracts manufacturing of it to AY Pharma Co. Ltd., a wholly owned subsidiary of Yoshindo. Yoshindo entered into the sales collaboration agreement with Teijin Pharma Ltd. (Head Office: Chiyoda-ku, Tokyo, President and Representative Director: Akihisa Nabeshima) in July, 2018, which is playing central role of health care business in Teijin group. Based on the agreement, Yoshindo and Teijin Pharma will jointly distribute and market YLB113 in Japan. YL Biologics is committed to take the biosimilar products with high medical needs as the targets for the pipeline and effectively develop them by making good use of the company’s rich know-how. YL biologics will contribute to the society and people by cutting medical spending and reducing financial burden of patients through stably providing its products to the medical field around the world. Yoshindo manufactures generic drugs with high quality and reasonable prices through its systems with research and development, manufacturing and sales and marketing. Furthermore, Yoshindo is accelerating manufacturing and sales activities for essential drugs such as infusion and dialysis fluid, and advancing research and development into biopharmaceuticals. Yoshindo is building new technologies and know-how, with the aim of remaining an irreplaceable pharmaceutical company for Japan moving into the future. Teijin Pharma intends to contribute the healthier lives of rheumatoid arthritis patients and improve their quality of life through putting YLB113 on their product line-up and accordingly further strengthening “Bone and Joint Field” as Teijin Pharma’s expertise area. For further information, please contact: YL Biologics Ltd. Liaison & Business Development Department Tel: +81-3-6667-5900 Yoshindo Inc. Corporate Planning Department Tel: +81-76-465-7736 Teijin Ltd. Corporate Communications Department Tel: +81-3-3506-4055

Phase 3Drug ApprovalClinical ResultLicense out/inNDA

100 Deals associated with Etanercept biosimilar(Lupin Ltd)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-radiographic axial spondyloarthritis	Australia	Lupin Australia Pty Ltd.	01 Oct 2020
Ankylosing Spondylitis	European Union	Biocon Biologics Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	Iceland	Biocon Biologics Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	Liechtenstein	Biocon Biologics Ireland Ltd.	20 May 2020
Ankylosing Spondylitis	Norway	Biocon Biologics Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	European Union	Biocon Biologics Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	Iceland	Biocon Biologics Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	Liechtenstein	Biocon Biologics Ireland Ltd.	20 May 2020
Arthritis, Psoriatic	Norway	Biocon Biologics Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	European Union	Biocon Biologics Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	Iceland	Biocon Biologics Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	Liechtenstein	Biocon Biologics Ireland Ltd.	20 May 2020
Axial Spondyloarthritis	Norway	Biocon Biologics Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	European Union	Biocon Biologics Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	Iceland	Biocon Biologics Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	Liechtenstein	Biocon Biologics Ireland Ltd.	20 May 2020
Enthesitis-Related Arthritis	Norway	Biocon Biologics Ireland Ltd.	20 May 2020
Plaque psoriasis	European Union	Biocon Biologics Ireland Ltd.	20 May 2020
Plaque psoriasis	Iceland	Biocon Biologics Ireland Ltd.	20 May 2020
Plaque psoriasis	Liechtenstein	Biocon Biologics Ireland Ltd.	20 May 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


YLB113-003 (EULAR2021)	Not Applicable	-	201	YLB113	zthbyevgsy(rwogkjcrwf) = ywgnnogizz xsffofnicc (vptwicrrws ) View more	-	02 Jun 2021
YLB113-002 (EULAR2021)	Phase 3	Injection Site Reaction \| Erythema	-	YLB113	itcqnpgrxg(mfdgjoqjpg) = ceflsulrrk lnrntuvklb (qyeyakktzr ) View more	Positive	02 Jun 2021
YLB113-002 (EULAR2021)	Phase 3	Injection Site Reaction \| Erythema	-	Reference Product (RP)	itcqnpgrxg(mfdgjoqjpg) = towaskkzbj lnrntuvklb (qyeyakktzr ) View more	Positive	02 Jun 2021
EULAR2019	Phase 3	Rheumatoid Arthritis	528	YLB113	bjbimmvtxt(guocqogyjg) = dqomswhxmi ncubggcgni (bglpdwdzpf )	Positive	12 Jun 2019

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