Govt Looks to Make Biosim­i­lars Ac­ces­si­ble Pro­poses changes to norms to cut the scope of am­biq­uity & speed up ap­provals, but move draws mixed re­ac­tion from in­dus­try bod­ies

SALIENTFEATURES

The Economic Times - - Companies & Economy - Prabha.Ragha­van@ times­group.com

New Delhi: In a move that may im­prove ac­cess to af­ford­able biotech­nol­ogy-based medicines known as biosim­i­lars, the gov­ern­ment has pro­posed changes to its guide­lines to cut the scope for am­bi­gu­ity and speed up ap­provals in In­dia. How­ever, a group of multi­na­tional phar­ma­ceu­ti­cal com­pa­nies has raised con­cerns over how the move may com­pro­mise with the safety of pa­tients.

Biosim­i­lars are copies of com­plex drugs based on liv­ing cells. They are dif­fer­ent from chem­i­cal-based generic drugs, which are ‘iden­ti­cal’ to the com­pound used in the orig­i­nal.

The draft of the “Guide­lines on Sim­i­lar Bi­o­log­ics 2016” pre­pared by the Cen­tral Drugs Stan­dard Con­trol Or­gan­i­sa­tion (CDSCO) and the De­part­ment of Biotech­nol­ogy ( DBT) has drawn mixed re­ac­tions from in­dus­try bod­ies.

“The 2012 Biosim­i­lar guide­lines were largely aligned with global re­quire­ments, whereas the pro­posed re­vised guide­lines sug­gest di­lu­tion of some pre­vi­ous re­quire­ments and might po­ten­tially com­pro­mise pa­tient safety,” Ran­jana Smetacek, di­rec­tor gen­eral of the Or­gan­i­sa­tion of Phar­ma­ceu­ti­cal Pro­duc­ers of In- dia, told ET.

On the other hand, lo­cal biosim­i­lar com­pa­nies have taken an op­ti­mistic view of the pro­pos­als, which in­cludes a key pro­vi­sion that cuts the ap­proval time­line by more than half.

The re­vised guide­lines, if im­ple­mented, could re­duce the time taken for ap­prov­ing biosim­i­lar drugs to 424 days from 990 days, ac­cord­ing to es­ti­mates by the As­so­ci­a­tion of Biotech-led En­ter­prises, a group of lo­cal biotech com­pa­nies.

The body ar­gued that the pro­posed guide­lines would bring more clar­ity on ap­proval pro­ce­dures and also en­sure higher safety and qual­ity stan­dards. The draft sets the min­i­mum num­ber of pa­tients re­quired for tri­als and stud­ies in var­i­ous phases — a de­tail not iden­ti­fied clearly in the 2012 guide­lines, ac­cord­ing to ABLE. Af­ter ap­proval, com­pa­nies would have to gen­er­ate data of the mar­keted drug over two years to prove it is safe for use in a wider pa­tient base, ac­cord­ing to the draft.

“…safety data may need to be col­lected af­ter mar­ket ap­proval through a pre-de­fined sin­gle arm study of gen­er­ally, more than 200 evalu­able pa­tients and com­pared to his­tor­i­cal data of the ref­er­ence prod­uct. The study should be com­pleted prefer­ably within two years of the mar­ket­ing per­mis­sion/man­u­fac­tur­ing li­cense un­less oth­er­wise jus­ti­fied,” ac­cord­ing to the draft.

Such re­vi­sions raise the bar for biosim­i­lar com­pa­nies seek­ing ap­proval for their drugs here, ac­cord­ing to ABLE pres­i­dent Pan­cha­pagesa Mu­rali. “So far, dif­fer­ent com­pa­nies were get­ting ap­proval for biosim­i­lar drugs in In­dia with much lower pa­tient data and post-mar­ket­ing data col­lec­tion was not ob­jec­tively de­fined,” he said.

The 2016 guide­lines also clar­ify con­di­tions for pro­vi­sions to waive spe­cific tri­als or re­duce the num­ber of pa­tients for cer­tain stud­ies.

“…if the firm con­ducts pre-ap­proval stud­ies that in­cluded more than 100 pa­tients on the pro­posed sim­i­lar bi­o­logic drug, the num­ber of pa­tients in phase IV study can be re­duced ac­cord­ingly so that the safety data (from both phase III and IV) is de­rived from a min­i­mum of 300 pa­tients treated with the sim­i­lar bi­o­log­ics,” the draft said.

The draft pro­poses that the ref­er­ence drug used in com­par­a­tive stud­ies sub­mit­ted for the prod­uct’s ap­proval is li­censed and mar­keted in In­dia and coun­tries that are part of the In­ter­na­tional Coun­cil for Har­mon­i­sa­tion of Tech­ni­cal Re­quire­ments for Pharmaceuticals for Hu­man Use. The pro­posed guide­lines are up for stake­holder sug­ges­tions and com­ments un­til April 30, ac­cord­ing to a CDSCO no­ti­fi­ca­tion. ‘In­no­va­tor’ prod­uct li­censed in In­dia or an ICH coun­try (ABLE es­ti­mates): Biosim­i­lar drugs could hit the mar­ket sooner two years us­ing more than 200 evalu­able pa­tients

The 2012 Biosim­i­lar guide­lines were largely aligned with global re­quire­ments, whereas the pro­posed re­vised guide­lines sug­gest di­lu­tion of some pre­vi­ous re­quire­ments and might po­ten­tially com­pro­mise pa­tient safety

RAN­JANA SMETACEK, Within So far, dif­fer­ent cos were get­ting ap­proval for biosim­i­lar drugs in In­dia with much lower pa­tient data and post­mar­ket­ing data col­lec­tion was not ob­jec­tively de­fined.

PAN­CHA­PAGESA MU­RALI

DI­REC­TOR GEN­ERAL, OPPI ABLE PRES­I­DENT

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