DRL_TC (tocilizumab biosimilar) / Dr. Reddy’s - LARVOL DELTA

Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers (clinicaltrials.gov) - P1 | N=300 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ May 2023 | Trial primary completion date: Dec 2023 ➔ May 2023

Trial completion • Trial completion date • Trial primary completion date • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab (Businesswire) - P1 | N=300 | NCT04885829 | Sponsor: Syneos Health | "Dr. Reddy’s Laboratories Ltd...announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase I study. This Phase I study used an intravenous (IV) formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products. The Phase I study...met all primary and secondary endpoints. Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product and the U.S. reference product was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU and U.S. reference products in terms of pharmacodynamic parameters and found no noteworthy differences in safety and immunogenicity across these three treatment groups."

P1 data • Giant Cell Arteritis • Immunology • Inflammation • Rheumatoid Arthritis • Rheumatology

Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers (clinicaltrials.gov) - P1 | N=300 | Active, not recruiting | Sponsor: Syneos Health | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers (clinicaltrials.gov) - P1 | N=300 | Active, not recruiting | Sponsor: Syneos Health | Trial completion date: Nov 2022 ➔ Jun 2023 | Trial primary completion date: Jun 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Giant Cell Arteritis • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6

Dr. Reddy’s Successfully Completes Phase 1 Study of DRL_TC, a Proposed Biosimilar of Tocilizumab (Businesswire) - P1 | N=300 | NCT04885829 | Sponsor: Syneos Health | "Dr. Reddy’s Laboratories Ltd...announced that its tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in a Phase 1 study. This Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of Dr. Reddy’s tocilizumab biosimilar candidate in comparison to reference products....Pharmacokinetic equivalence of DRL_TC to the EU reference medicinal product* and the U.S. reference product** was successfully demonstrated. The clinical trial also confirmed the similarity between DRL_TC and the EU* and U.S.** reference products in terms of pharmacodynamic parameters....The company is initiating a global Phase 3 study with the aim of comparing the efficacy, safety, tolerability and immunogenicity of DRL_TC with the reference product in patients with moderate to severe active rheumatoid arthritis."

New P3 trial • P1 data • Giant Cell Arteritis • Immunology • Rheumatoid Arthritis