CDSCO Panel Seeks Protocol Revisions in Levim Lifetech's Teriparatide Biosimilar Study
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has opined that LevimLifetech revise the protocol by incorporating the changes for conducting a Phase I/III clinical trial of its biosimilar Teriparatide Injection IP 600 mcg/2.4 mL (250 mcg/mL) (rDNA origin).
This came after the The firm presented a proposal to conduct a clinical trial titled, “A Prospective,Randomized, Assessor-blinded, Multicentric, Parallel Group Phase-I/III Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Biosimilar Teriparatide of Levim Lifetech Pvt. Ltd. with Reference Product (Forteo® of Eli Lilly) in Subjects with Osteoporosis at High Risk of Fracture vide protocol no. ICS/LEV/2025-006 Version: 1.0 dated 09.07.2025.
Teriparatide is a recombinant parathyroid hormone used for the treatment of osteoporosis.Teriparatide is a recombinant parathyroid hormone (PTH) analog and a potent osteoanabolic agent. It is made up of the first amino(N)-terminal 34 amino acids of the human PTH. First approved in the United States in November 2002 and in Europe in April 2003, teriparatide makes the first approved drug in a new category of osteoporosis therapy called anabolic therapy. Teriparatide is used in the treatment of osteoporosis in men and women.
After detailed deliberation, the committee recommended revising the protocol by incorporating the following changes:
a. Outcome parameters of DXA should be clearly defined.
b. The DXA reports should be evaluated by a qualified Endocrinologist.
c. Exclusion and inclusion criteria should be re-evaluated by adding objectivity to the criteria.
d. Safety assessments should be clearly addressed including the antidrug antibodies.
e. Objective definition of protocol violation should be stated.
