Starjemza (ustekinumab-hmny) / Dr. Reddy’s, Bio-Thera Solutions, Pharmapark, Hikma, Biomm, Gedeon Richter, Astra Industrial Group - LARVOL DELTA

Hikma Pharmaceuticals announces the launch of STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing STELARA (ustekinumab) Injection (Hikma Press Release)

Biosimilar launch • Crohn's disease • Psoriasis • Psoriatic Arthritis

Mark Cuban Cost Plus Drug Company Expands Access with Addition of Starjemza (ustekinumab-hmny) to Give Patients More Power Over Prescription Costs (PRNewswire) - "Every medication offered through the platform is priced based on its actual acquisition cost plus a modest fixed markup and pharmacy fee. Starjemza will be listed at a starting price of $345 per quarter (plus shipping) for the 90 mg/mL pre-filled syringe (PFS). Additional configurations, including the 45 mg/mL and 130 mg/mL PFS, will also be offered and priced in accordance with the company's transparent cost-plus model."

Pricing • Crohn's disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

The European Commission (EC) Approves Bio-Thera Solutions' BAT2206 (USYMRO, ustekinumab), a biosimilar referencing Stelara (PRNewswire) - "Gedeon Richter have rights to market BAT2206 in Europe under the brand name USYMRO."

EMA approval • Crohn's disease • Psoriasis • Psoriatic Arthritis

A Phase 3, Randomized, Double-blind, Active-controlled Clinical Study to Compare BAT2206, a Ustekinumab Biosimilar, with Ustekinumab Reference Product in Patients with Moderate-to-severe Psoriasis: Treatment Period 2 Results (Post Week 28 to Week 52). (PubMed, J Am Acad Dermatol) - "Outcomes were comparable among the groups in TP2, with no impact from the UST-to-BAT2206 switch."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Bio-Thera Solutions Receives Positive CHMP Opinion for USYMRO (ustekinumab), a Biosimilar Referencing Stelara (PRNewswire) - "Bio-Thera Solutions Inc...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for USYMRO (ustekinumab), a biosimilar monoclonal antibody referencing Stelara....This positive CHMP opinion on USYMRO was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package."

CHMP • Crohn's disease • Psoriasis • Psoriatic Arthritis

Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing STELARA (ustekinumab) Injection (PRNewswire) - "Bio-Thera Solutions, Ltd...and innovative assets and Hikma Pharmaceuticals PLC, along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. STARJEMZA is Bio-Thera's third FDA approved product....A randomized double-blind, single-dose, three-arm, parallel phase I study compared the pharmacokinetics, safety, and immunogenicity of STARJEMZA with both the US and EU Stelara in healthy volunteers. A multicenter, randomized, double-blind, parallel-arm, phase III study compared STARJEMZA with Stelara for efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis."

FDA approval • Psoriasis

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

The Phase III clinical study results of Bio-Thera BAT2206 (a biosimilar developed based on ustekinumab) were published in the Journal of the American Academy of Dermatology [Google translation] (Bio-thera Press Release) - P3 | N=556 | NCT04728360 | Sponsor: Bio-Thera Solutions | "The Phase III clinical study of BAT2206 is an international multicenter, randomized, double-blind, parallel-controlled study designed to compare...BAT2206 and Xidanuo in subjects with moderate to severe psoriasis....The results showed that at week 8 , the least squares (LS) means (SE) of the PASI score CfB percentage of the Xidanuo group and the BAT2206 group were -76.507 (2.6526 ) and -75.543 (2.6847), respectively , and the LS mean difference (SE) was 0.964 ( 1.8952); at week 12 , the LS means (SE) of the Xidanuo group and the BAT2206 group were -86.813 (2.0105) and -85.039 (2.0731), respectively , and the LS difference (SE) was 1.774 (1.4912) . The confidence intervals of the above efficacy differences all fell completely within the pre-set equivalence margins of various regulatory agencies, proving that the biosimilar BAT2206 is equivalent to Xidanuo."

P3 data • Psoriasis

Bio-Thera Solutions Partners with Tabuk Pharmaceuticals to Commercialize BAT2206, a Stelara (Ustekinumab) Biosimilar in Saudi Arabia (PRNewswire) - "Bio-Thera Solutions Inc...announced the company has partnered with Tabuk Pharmaceutical Manufacturing Company...for BAT2206, its ustekinumab biosimilar, under which Tabuk will have exclusive rights to manufacture, distribute and market the drug in Saudi Arabia....This partnership will leverage Tabuk's strong local presence, sales and marketing capabilities in Saudi Arabia. Under this agreement Tabuk Pharmaceuticals will hold the marketing authorization and will be responsible to manufacture, register, import, and promote BAT2206 in Saudi Arabia. Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China."

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

A Randomized Phase III Study to Compare Efficacy and Safety of BAT2206 (Proposed Ustekinumab Biosimilar) with Reference Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis. (PubMed, J Am Acad Dermatol) - "BAT2206 and UST were comparable in terms of efficacy, safety, PK, and immunogenicity."

Clinical • Journal • P3 data • Dermatology • Immunology • Psoriasis

Bio-Thera and Richter Execute Exclusive Commercialization Agreement for BAT2206, a Proposed Stelara Biosimilar, for EU countries, UK, Switzerland and other selected countries (PRNewswire) - "Bio-Thera Solutions...announce today they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Stelara (ustekinumab). Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206 and Bio-Thera has filed BAT2206 for regulatory approval with EMA on 1 July 2024. Richter will have exclusive rights to commercialize the product in the European Union (EU), the UK, Switzerland and selected other countries."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 with Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis (EADV 2024) - "The current study showed that BAT2206 and Ustekinumab are similar in terms of efficacy, safety, PK, and immunogenicity. Additionally, the transition from Ustekinumab to BAT2206 in TP2 had no impact on efficacy, safety, PK, or immunogenicity."

Clinical • P3 data • Dermatology • Immunology • Psoriasis • IL12A

Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara in the US and EU (PRNewswire) - "Bio-Thera Solutions Inc...announced that the FDA has accepted the BLA for BAT2206, a proposed interchangeable biosimilar to Stelara (ustekinumab) seeking a commercial license in the United States of America. In addition, Bio-Thera also announced that the EMA has accepted the MAA for BAT2206 seeking a commercial license in the European Union (EU). A Biologics License Application seeking approval for BAT2206 is also currently under review by the China National Medicinal Product Administration (NMPA)....This BLA/MAA for BAT2206 is based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package."

China filing • EMA filing • FDA filing • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Bio-Thera: BAT2206 injection marketing authorization application accepted by US FDA and European EMA [Google translation] - "Bio-Thera announced that the company submitted a biologics marketing application for BAT2206 injection to the US FDA and the European EMA, and recently received a notice of acceptance. The drug is ustekinumab injection, which has been approved in many regions around the world." "

EMA filing • FDA filing • Immunology • Psoriasis • Psoriatic Arthritis

Biotech’s marketing authorization application for BAT2206 (ustekinumab) injection was accepted by the National Medical Products Administration [Google translation] (Bio-thera Press Release) - "Biotech Biopharmaceutical Co., Ltd...announced today that it has received the 'Acceptance Notice' approved and issued by the State Food and Drug Administration (hereinafter referred to as the 'NMPA') regarding the company's drug marketing authorization application for the company's research drug ustekinumab injection (hereinafter referred to as 'BAT2206') Book.'"

Non-US regulatory • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

Bio-Thera Solutions Announces Positive Results from Phase 3 Study of BAT2206, a Proposed Biosimilar Referencing Stelara (PRNewswire) - P3 | N=556 | NCT04728360 | Sponsor: Bio-Thera Solutions | "Bio-Thera Solutions, Ltd...announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara^® (ustekinumab). The primary endpoint of this study was improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly similar with Stelara® in patients with moderate to severe plaque psoriasis."

P3 data • Dermatology • Immunology • Psoriasis

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=556 | Completed | Sponsor: Bio-Thera Solutions | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2023 ➔ Oct 2022

Trial completion • Trial primary completion date • Dermatology • Immunology • Psoriasis

Bio-Thera Solutions Expands Partnership with Biomm in Brazil with Addition of BAT2206, a Stelara Biosimilar (Businesswire) - "Bio-Thera Solutions, Ltd...today announced the company has entered into a licensing and supply agreement with Biomm SA, for BAT2206, its ustekinumab biosimilar, under which Biomm will have exclusive rights to distribute and market the drug in Brazil....This partnership will leverage Biomm’s strong local presence, sales and marketing capabilities in Brazil. Bio-Thera will be responsible for completing global development and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China."

Licensing / partnership • Crohn's disease • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatology • Ulcerative Colitis

Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. (PubMed, BioDrugs) - P1 | "Pharmacokinetic similarity between BAT2206 and ustekinumab (USA or European Union sourced) was confirmed. The three groups had similar safety profiles, and the investigational drugs were well tolerated by subjects."

Journal • P1 data • PK/PD data

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=556 | Active, not recruiting | Sponsor: Bio-Thera Solutions | Recruiting ➔ Active, not recruiting | N=406 ➔ 556

Enrollment change • Enrollment closed • Dermatology • Immunology • Psoriasis

Bio-Thera Solutions Expands Partnership with Pharmapark in Russia and other CIS Countries with Addition of BAT2206, a Stelara Biosimilar (Yahoo Finance) - “Bio-Thera Solutions, Ltd…announced the company has reached licensing and supply agreements with Pharmapark LLC, for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries. Bio-Thera and Pharmapark’s partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries….Bio-Thera’s BAT2206…is currently being evaluated in a global Phase III clinical study including patients from China, Russia and other countries. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.”

Licensing / partnership • Immunology • Psoriasis

Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3; N=406; Recruiting; Sponsor: Bio-Thera Solutions; Not yet recruiting ➔ Recruiting; Initiation date: Feb 2021 ➔ Jul 2021; Trial primary completion date: Nov 2022 ➔ Apr 2023

Clinical • Enrollment open • Trial initiation date • Trial primary completion date • Dermatology • Immunology • Psoriasis

Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects (clinicaltrials.gov) - P1; N=270; Completed; Sponsor: Bio-Thera Solutions; Not yet recruiting ➔ Completed; Trial completion date: Sep 2021 ➔ Apr 2021

Clinical • Trial completion • Trial completion date • Dermatology • Immunology • Psoriasis

Bio-Thera Solutions and Hikma Pharmaceuticals Announce Exclusive Commercialization and License Agreement for BAT2206 in the US, a Proposed Biosimilar Referencing Stelara (ustekinumab) (Businesswire) - "Bio-Thera Solutions, Ltd...announced that they have entered into a commercialization and license agreement to commercialize BAT2206....in the United States (US)...Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT2206. Hikma will have exclusive rights to commercialize the product in the US. The agreement also provides Hikma with a first-right-to-negotiate to add Europe (excluding CIS countries). Bio-Thera is eligible for an upfront payment of $20 million as well as further development and commercial milestones of up to $130 million."

Licensing / partnership • Immunology

Bio-Thera Solutions Announces the First Patient Dosed in Phase III Clinical Trial for BAT2206, a Proposed Biosimilar of Stelara (Ustekinumab) (Businesswire) - "Bio-Thera Solutions, Ltd...today announced that the first patient has been dosed in a Phase III clinical study for BAT2206, a proposed biosimilar of Stelara® (ustekinumab). The clinical study is a multicenter, randomized, double-blind, and parallel controlled study to compare the efficacy and safety of BAT2206 to Stelara® in moderately to severely psoriatic (PsO) patients that is expected to enroll approximately 472 volunteers."

Trial status • Immunology • Psoriasis