The study pesented at the American Diabetes Association 77th Scientific Sessions compared Mylan/Biocon’s MYL-1501D, a proposed biosimilar to Sanofi-Aventis’ insulin glargine, with the reference product.
A double-blind, randomized, 3-way crossover study comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of MYL-1501D, Mylan/Biocon’s proposed biosimilar to Sanofi-Aventis’ originator insulin glargine (US and EU versions of Lantus) reported PK/PD equivalence between the 3 products in 114 patients with type 1 diabetes (T1D). The findings, presented during a poster session at the American Diabetes Association 77th Scientific Sessions on June 10, 2017, in San Diego, also showed that both insulin glargine and the biosimilar were generally well tolerated and did not display significant safety issues.
Lead researcher Tim Heise, MD, of Profil Institut fur Stoffwechselforschung GmbH, Neuss, Germany, and colleagues noted that the study’s analysis of PK/PD factors were performed to meet the guidance issued by the FDA and the European Medicines Agency (EMA) on the development and approval of biosimilars to show biosimilars are comparable to the originator biologic product. Therefore, the objective of the study was to evaluate PK/PD bioequivalence with regard to total and maximum plasma insulin concentrations of the 3 insulin glargine preparations, each administered by subcutaneous injection of a single dose of 0.4 U/kg in patients with T1D.
Patients included in the study were generally healthy male or female nonsmokers aged 18 to 55 years who had a body mass index between 18.5 and 29.9 kg/m2 and were on stable insulin treatment for at least 6 months before the screening visit. Patients with insulin resistance were excluded from the study.
The study met its primary PK endpoints; mean serum insulin and plasma metabolite concentration profiles of the 3 insulin glargine preparations were shown to be similar. Additionally, the 3 drugs had nearly identical glucose infusion rate (GIR) profiles, which was the primary PD endpoint. Thus, the study demonstrated bioequivalence of MYL-1501D and the US and EU versions of Lantus in T1D patients for the primary PK and PD end points.
Rates of adverse events (AEs) observed were similar for the 3 insulin glargine formulations, with no serious AEs or AEs leading to withdrawal.
Currently, the only FDA-approved “follow-on” insulin product in the United States is Eli Lilly’s Basaglar, a biosimilar of Sanofi’s Lantus, which was approved in late 2015. The FDA is currently reviewing other insulin glargine analogs.
Mylan announced that the data presented from this study and others on MYL1501D in patients with type 1 and type 2 diabetes confirmed its efficacy, safety, and immunogenicity in comparison with Lantus.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability
April 16th 2024Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.
"Not So Different": How the BPCIA Transition Will Affect Biosimilar Uptake
April 10th 2020This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.
AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars
March 20th 2024Two posters presented at the American Academy of Dermatology (AAD) annual meeting examined the effects of switching from reference ustekinumab and adalimumab to biosimilar versions in patients with different types of psoriasis.