BAT2506 (golimumab biosimilar) / Bio-Thera Solutions, Pharmapark, Stada, Intas, Dr. Reddy’s - LARVOL DELTA

Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion (Streetinsider.com) - "The CHMP's positive opinion will now be referred for the European Commission to grant marketing authorization for the product that was developed by Bio-Thera under the code BAT2506. Following approval, the monoclonal antibody would be supplied as 50mg/0.5mL and 100mg/mL in a pre-filled syringe. The marketing authorization would apply across the 27 member states of the European Union, in addition to Norway, Iceland and Lichtenstein...The positive CHMP opinion on Gotenfia/BAT2506 was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity with the reference biologic product."

CHMP • Ankylosing Spondylitis • Idiopathic Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions…received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia (golimumab) biosimilar candidate referencing Simponi (PRNewswire) - "A randomized double-blind, single-dose, three-arm, parallel group Phase 1 study compared the pharmacokinetics, safety and immunogenicity of BAT2506 with both the EU and US reference product in healthy volunteers. In addition, a randomized, double-blind, multi-dose, three-arm, parallel group Phase 3 study compared BAT2506 with the reference product in terms of efficacy, pharmacokinetic, safety and immunogenicity profiles, in psoriatic arthritis (PsA) patients."

CHMP • Psoriatic Arthritis

Bio-Thera Solutions Announces Expansion of Partnership with Intas Pharmaceuticals for BAT2506, a Proposed Biosimilar Referencing Simponi (golimumab), through Exclusive Commercialization and License Agreement in Canada (PRNewswire)

Licensing / partnership • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Bio-Thera Solutions Announces FDA Accepts Biologics License Application for BAT2506, a Proposed Biosimilar to Simponi (PRNewswire) - "Bio-Thera Solutions...announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is 16th May 2026....The BLA requests approval for all approved presentations and all currently approved indications for Simponi, including 1) moderately to severely active rheumatoid arthritis (RA) in adults, used with methotrexate, 2) active psoriatic arthritis (PsA) in adults, used alone or with methotrexate, 3) active ankylosing spondylitis (AS) in adults and 4) moderately to severely active ulcerative colitis (UC) in adults who depend on corticosteroids or haven't responded well to or tolerated other treatments. The BLA also requests BAT2506 be declared interchangeable with Simponi....The BLA submission is based on a comprehensive analytical, non-clinical, and clinical data package submitted to the FDA."

BsUFA date • FDA filing • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Bio-Thera and Dr. Reddy's Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara Biosimilar, and BAT2506, a Proposed Simponi Biosimilar, for Southeast Asia (PRNewswire) - "Bio-Thera Solutions...and Dr. Reddy's Laboratories SA...announce today they have reached commercialization and license agreements for BAT2206, a proposed Stelara® biosimilar, and BAT2506, a proposed Simponi biosimilar....Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy's will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Southeast Asia, including Cambodia, Indonesia, Malaysia, Philippines, Thailand, Vietnam. In addition, Dr. Reddy's will also receive the exclusive commercial rights to BAT2206 in Colombia."

Commercial • Crohn's disease • Immunology • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Bio-Thera Announces that the Marketing Authorization Application for the First Domestic Golimumab Biosimilar (BAT2506) Has Been Accepted by NMPA [Google translation] (Biothera Press Release) - "The company announced today that the marketing authorization application for BAT2506 , a biosimilar developed based on Simponi (golimumab), has been accepted by the National Medical Products Administration. BAT2506 (golimumab) injection is a golimumab biosimilar developed by Bio-Thera in accordance with the biosimilar guidelines of China NMPA , US FDA and European EMA."

China filing • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement with Bio-Thera for BAT2506, a Proposed Golimumab Biosimilar (PRNewswire) - "Accord BioPharma...announced today that it has reached an exclusive commercialization and license agreement with Bio-Thera Solutions ('Bio-Thera') for BAT2506, a biosimilar candidate to Simponi (golimumab)....This partnership will expand Bio-Thera's efforts to bring more immunology biosimilars to patients in the USA....Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2506, while Accord will have exclusive rights to commercialize the product in the U.S."

Licensing / partnership • Ankylosing Spondylitis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi, in the European Union (PRNewswire) - "Bio-Thera Solutions Inc...today announced that the EMA has accepted the MAA for BAT2506, a proposed biosimilar to Simponi (golimumab), seeking a commercial license in the European Union (EU)...The MAA for BAT2506 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package. Extensive analytical characterization of the structural, physicochemical, and biological properties of BAT2506 was conducted and supports biosimilarity to the reference product. Additionally, a randomized double-blind, single-dose, three-arm, parallel group Phase 1...while a randomized, double-blind, multi-dose, two-arm, parallel group Phase 3 confirmatory study compared BAT2506 to the EU golimumab reference product to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles, in subjects with Active Psoriatic Arthritis."

EMA filing • Immunology • Psoriatic Arthritis

Bio-Thera and STADA Reach Exclusive Agreement for BAT2506, a Proposed Golimumab Biosimilar, in the EU and UK (PRNewswire) - "Bio-Thera Solutions...and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have reached an exclusive commercialization and license agreement for BAT2506, a biosimilar candidate to Simponi (golimumab). Under the agreement, Bio-Thera Solutions ('Bio-Thera') will maintain responsibility for development, manufacturing, and supply of BAT2506. STADA Arzneimittel AG ('STADA') will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries. Bio-Thera will receive an upfront payment of US$10 million, as well as further development and commercial milestones of up to US$147.5 million, subject to the fulfillment of certain conditions."

Licensing / partnership • Ankylosing Spondylitis • Idiopathic Arthritis • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatoid Arthritis

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=704 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi® (clinicaltrials.gov) - P1 | N=375 | Completed | Sponsor: Bio-Thera Solutions | Recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Jul 2023

Trial completion • Trial completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi® (clinicaltrials.gov) - P1 | N=375 | Recruiting | Sponsor: Bio-Thera Solutions | Not yet recruiting ➔ Recruiting | Trial primary completion date: Dec 2023 ➔ Jun 2023

Enrollment open • Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=704 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi® (clinicaltrials.gov) - P1 | N=375 | Not yet recruiting | Sponsor: Bio-Thera Solutions

New P1 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects (clinicaltrials.gov) - P1; N=182; Completed; Sponsor: Bio-Thera Solutions; Recruiting ➔ Completed; Trial primary completion date: Apr 2020 ➔ Dec 2020

Trial completion • Trial primary completion date • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis (clinicaltrials.gov) - P3; N=700; Recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P3 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Phase I, Randomized, Double-Blind, Single-Dose, Parallel-Group Study to compare Pharmacokinetic Similarity, Safety, and Immunogenicity Between BAT2506 and Golimumab in Healthy Chinese Male Subjects. (PubMed, Expert Opin Investig Drugs) - P1 | "Therefore, BAT2506 meets the criteria for biosimilarity to golimumab. Trial registration: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04152759)."

Clinical • Journal • PK/PD data

Comparative Study to Evaluate the Pharmacokinetics of BAT2506 vs Simponi® in Healthy Subjects (clinicaltrials.gov) - P1; N=182; Recruiting; Sponsor: Bio-Thera Solutions

Clinical • New P1 trial