Positive Results from Phase 1 PK-PD Study with Biosimilar Insulin Glargine

[Northerner]

Biocon, Asia's premier biotechnology company, today announced positive results from a
Phase 1 comparative study conducted in Germany of its Biosimilar Insulin Glargine in Type 1 Diabetes Mellitus (T1DM) patients.

This randomized, double-blind, euglycemic clamp study was conducted in T1DM patients to evaluate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Biocon?s Insulin Glargine against the innovator product (Lantus?). The trial met all its primary and secondary endpoints.

These encouraging results indicate that Biocon?s Insulin Glargine is equivalent to the innovator product in terms of PK and PD. These robust clinical data along with extensive physicochemical and biological characterization data generated to date between Biocon?s Insulin Glargine and the innovator product will enable Biocon to start its Phase 3 program in the U.S. and E.U. aimed at demonstrating comparative safety, efficacy and immunogenicity in diabetes mellitus patients.

http://www.businesswireindia.com/PressRelease.asp?b2mid=32073

 

[trophywench]

Perhaps they'll call it (Sri) Lankus? LOL

I should imagine it's an effort to obtain cheaper insulins for the Asian home market - and jolly good luck to them, although the major mfrs allegedly do change their prices for different markets. Here, Lantus costs the NHS ?41.50 for 3 x 3ml vials, whereas Levemir costs ?42.00 for the same, so it's not cheap.

 

[Northerner]

Perhaps they'll call it (Sri) Lankus? LOL

I should imagine it's an effort to obtain cheaper insulins for the Asian home market - and jolly good luck to them, although the major mfrs allegedly do change their prices for different markets. Here, Lantus costs the NHS ?41.50 for 3 x 3ml vials, whereas Levemir costs ?42.00 for the same, so it's not cheap.

I believe the companies charge about twice as much in the US because it;s mostly funded by health insurance companies, which in turn are funded by big premiums Banting wanted it all to be free, but the pharmas have got round it by patenting analogues.