Introduction: The use of growth factors and cytokines in skin rejuvenation and reversal of photo ageing is a novel anti-ageing treatment. These factors provide a microenvironment that seems to favor tissue repair and regeneration. Methods: An open label, monocentric, single arm study to evaluate anti-ageing efficacy of conditioned medium obtained from adult human bonemarrow derived allogenic mesenchymal stromal cells (BMMSC) along with excipients formulated into a cosmetic serum, was conducted in 40 Indian female population aged 35 to 60 years, belonging to skin type IV -VI of Norwood Scale for a duration of 90 days. Parameters-fine lines, wrinkles, crow's feet, evenness of skin tone, skin firmness/laxity, hydration of skin, homogeneity of age spots, and visible pores were used to evaluate the anti-ageing and rejuvenating properties of the test product. Results and Discussion: Improvement was seen in majority of parameters starting from 15 -30 days. Product was safe and well tolerated as per the dermatologist and subjects' self-assessment.

Aim: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence (BE) of MYL-1601D biosimilar with originator, NovoLog (Ref-InsAsp-US), and NovoRapid (Ref-InsAsp-EU).Materials and Methods: This was a double-blind, randomized, crossover study that enrolled 71 healthy subjects to receive a single subcutaneous dose (0.2 U/kg) of each formulation under automated euglycaemic clamp conditions (ClampArt, level 81 mg/dL, duration 12 hours postdose). Primary PK endpoints were area under the plasma insulin aspart concentration-time curve from 0 to 12 hours (AUC 0-12h ) and maximum plasma insulin aspart concentration (C max ). Primary PD endpoints were area under the glucose infusion rate (GIR) time curve from 0 to 12 hours (AUC GIR0-12h ) and maximum GIR (GIR max ). Insulin aspart in plasma was quantified using immunoaffinity purification followed by ultraperformance liquid chromatography and tandem mass spectrometric detection. The pairwise comparisons of geometric least square mean (LS-mean) ratio for a 90% confidence interval (CI) of primary PK, and 90% CIs (MYL-1601D vs. Ref-InsAsp-US) and 95% CIs (MYL-1601D vs. Ref-InsAsp-EU) of primary PD variables, were to be within 80% to 125% to show BE.Results: MYL-1601D showed PK BE to both Ref-InsAsp-US (AUC 0-12h geometric LS-mean ratio 102.17, 90% CI [100.26; 104.11]; C max 106.13 [100.71; 111.85]) and Ref-InsAsp-EU

Background MYL-1601D is a proposed biosimilar of originator insulin aspart, Novolog ® /NovoRapid ® (Ref-InsAsp-US/ Ref-InsAsp-EU). Objective This study assessed the immunogenicity, efficacy, and safety of MYL-1601D with Ref-InsAsp-US in patients with type 1 diabetes mellitus (T1D).Methods This was a 24-week, open-label, randomized, phase III study. Patients were randomized 1:1 to mealtime MYL-1601D or Ref-InsAsp-US in combination with insulin glargine (Lantus SoloSTAR ® ) once daily. The treatment-emergent antibody response (TEAR) rate (defined as patients who were anti-insulin antibody [AIA] negative at baseline and became positive at any timepoint post-baseline or patients who were AIA positive at baseline and demonstrated a 4-fold increase in titer values at any timepoint post-baseline) was the primary endpoint. The study also compared the change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), prandial, basal, and total daily insulin, 7-point self-monitored blood glucose (SMBG) profiles, immunogenicity, and adverse events (AEs) including hypoglycemia. Results In total, 478 patients were included in the intent-to-treat analysis (MYL-1601D: 238; Ref-InsAsp-US: 240) set. The 90% confidence interval (CI) for the primary endpoint was within the pre-defined equivalence margin of ±11.7% and the treatment differences (SE) in TEAR responders between the treatment groups was − 2.86 (4.16) with 90% CI − 9.71 to 3.99. The mean (SD) changes from baseline for HbA1c, FPG, and insulin dosages were similar in both groups at week 24. The safety profiles including hypoglycemia, immune-related events, AEs, and other reported variables were similar between the treatment groups at week 24. Conclusions MYL-1601D demonstrated similar immunogenicity, efficacy, and safety profiles to Ref-InsAsp-US in patients with T1D over 24 weeks. Clinical Trial Registration ClinicalTrials.gov: NCT03760068.

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