In a first, Bio­con in­sulin gets Ja­pan nod

The Financial Express - - COMPANIES - Fe Bureau

Ben­galuru, March 28: Bio­pharma ma­jor Bio­con on Mon­day be­came the first In­dian com­pany to re­ceive reg­u­la­tory ap­proval for a biosim­i­lar in­sulin in Ja­pan. This ap­proval will en­able the com­pany to ex­port Glargine, a biosim­i­lar in­sulin in a dis­pos­able pen to Ja­pan for treat­ment of di­a­betes.

In Ja­pan, Bio­con has part­nered with FU­JI­FILM Pharma Co Ltd (FFP) to launch this prod­uct. FU­JI­FILM con­ducted lo­cal clin­i­cal trial in Ja­pan. They also paid li­cens­ing fee to Bio­con for the ini­tial devel­op­ment of Glargine.

“The In­sulin Glargine ap­proval in the highly reg­u­lated mar­ket like Ja­pan, marks a huge cred­i­bil­ity mile­stone for Bio­con. We see this as a sig­nif­i­cant achieve­ment in our jour­ney of mak­ing global im­pact in di­a­betes man­age­ment through our af­ford­able biosim­i­lar in­sulins,” Mazum­dar-Shaw said.

The ap­proval from the Min­istry of Health, Labour and Wel­fare (MHLW) of Ja­pan marks Bio­con's en­try into reg­u­lated mar­ket with biosim­i­lars. The mar­ket in Ja­pan is es­ti­mated at $144 mil­lion for in­sulin Glargine. The global mar­ket for the same is es­ti­mated at over $10 bil­lion.

The com­pany had un­veiled a med­i­cal de­vices man­u­fac­tur­ing fa­cil­ity at Ben­galuru in Septem­ber last year as part of its com­mit­ment to the Make in In­dia pro­gramme. The com­pany had also launched Basa­log One, a Glargine dis­pos­able pen for In­dian mar­ket.

Bio­con is also pre­par­ing to file ap­pli­ca­tion for four biosim­i­lars in­clud­ing in­sulin Glargine in the reg­u­lated mar­kets of the US and Europe dur­ing the next fi­nan­cial year. Bio­con has partnership with US drug ma­jor My­lan for these biosim­i­lars in those mar­kets.

Un­der the terms of the deal with Ja­panese firm, Bio­con will get roy­alty on sale. will launch its ready-to-use, pre­filled dis­pos­able pen with 3 ml of 100IU In­sulin Glargine.

The ap­proval for In­sulin Glargine has been ob­tained post suc­cess­ful com­ple­tion of ini­tial devel­op­ment by Bio­con and lo­cal Phase III Clin­i­cal Stud­ies in over 250 Type 1 Di­a­betes pa­tients by our part­ner in Ja­pan, Bio­con Chair­per­son & Manag­ing Di­rec­tor Ki­ran Mazum­dar-Shaw said.

With this ap­proval Bio­con aims to cap­ture a por­tion of the Ja­panese Glargine mar­ket es­ti­mated at $144 mil­lion, which is the sec­ond largest mar­ket out­side of North Amer­ica & Europe and is largely dom­i­nated by dis­pos­able pens, she said.

Bio­con’s man­u­fac­tur­ing fa­cil­i­ties for In­sulin Glargine, and dis­pos­able pen assem­bly fa­cil­ity, were in­spected and ap­proved by the Ja­panese reg­u­la­tory au­thor­i­ties.

The per capita spend­ing on phar­ma­ceu­ti­cals in Ja­pan is the sec­ond highest among OECD coun­tries af­ter the US, and the gov­ern­ment is striv­ing to ra­tio­nalise health­care spends by en­cour­ag­ing the en­try of high qual­ity yet af­ford­able fol­low-on bi­o­log­ics. This ap­proval will en­able Bio­con to ad­dress the grow­ing needs of di­a­betes pa­tients in Ja­pan which re­ported 7.2 mil­lion cases in 2015.

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