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The study aimed to compare the pharmacokinetics of 2 pemetrexed formulations (Pemgem, Dr. Reddy's Laboratories w.r.t; Alimta, Eli Lilly) in adult chemonaive subjects with adenocarcinoma stage III/IV non-small cell lung cancer. All patients received 500 mg/m 2 pemetrexed (Alimta or Pemgem) as a 10-minute infusion on day 1 of a 21-day cycle. Plasma pemetrexed concentrations were determined on day 1 of cycle 1. Area under the concentration-time curve (AUC 0-inf ) and the maximum plasma concentration (C max ) were estimated using noncompartment analysis and compared between the 2 arms. Forty-eight patients were enrolled in the study, 24 in each arm. Patient demographics were comparable in both arms. Mean AUC 0-inf for the generic and innovator formulations was 218.2 ± 19.18 and 223.6 ± 34.24 μg·h/mL, respectively, and mean C max was 119 ± 13.44 and 113 ± 7.26 μg/mL, respectively. Volume of distribution of pemetrexed was 17.5 and 27.6 L, clearance was 4.2 versus 4.72 L/h, and half-life was 4.3 and 4.83 h in the 2 arms respectively. Both formulations showed comparable response rates (objective response of 45% versus 50% in the Pemgem and Alimta arms, respectively) and similar safety profiles. To conclude, Pemgem showed pharmacokinetic and safety profiles similar to Alimta. Substitution of Alimta with Pemgem will be cost-effective and likely to yield comparable efficacy., (© 2017, The American College of Clinical Pharmacology.)