De­vel­op­ment of Af­ford­able Bi­o­log­i­cal Drugs in In­dia

BioSpectrum (India) - - BIO CONTENT -

Glob­ally, bi­o­log­ics are play­ing an in­creas­ing role in ad­dress­ing un­met med­i­cal needs. The abil­ity of bi­o­log­ics to tar­get spe­cific pro­teins makes them more ef­fec­tive treat­ments than small mol­e­cule ther­a­pies for a va­ri­ety of med­i­cal ill­nesses and con­di­tions. Bi­o­logic ther­a­pies such as in­sulin, ery­thro­poi­etin, growth hor­mones and mon­o­clonal an­ti­bod­ies are play­ing an in­valu­able role in treat­ing se­ri­ous ill­nesses such as di­a­betes, ane­mia, re­nal dis­eases and cancer.

Over 1.7 mil­lion new cases of cancer and over 880,000 cancer deaths are pro­jected in In­dia by 2020 as per the In­dian Coun­cil of Med­i­cal Re­search (ICMR). The num­ber of peo­ple with di­a­betes are ex­pected to al­most dou­ble to 134 mil­lion by 2025 from 72 mil­lion in 2017. In such a sce­nario, pa­tients, care­givers and med­i­cal prac­ti­tion­ers in the coun­try need af­ford­able ac­cess to safe, ef­fi­ca­cious and high qual­ity bi­o­logic medicines to fight chronic dis­eases.

How­ever, de­vel­op­ing bi­o­log­ics drugs is a cap­i­tal in­ten­sive and re­search-in­ten­sive ex­er­cise with in­her­ently long ges­ta­tional time lines for prod­uct com­mer­cial­iza­tion. Un­like small mol­e­cule gener­ics, the de­vel­op­ment process of a biosim­i­lar does not end at bioavail­abil­ity and bioe­quiv­a­lence (BA\ BE) stud­ies but ex­tends to large and lengthy clin­i­cal tri­als, which add to the cost of de­vel­op­ment as well as stretch the ges­ta­tional time­lines for prod­uct com­mer­cial­iza­tion.

Cre­at­ing man­u­fac­tur­ing in­fra­struc­ture for bi­o­log­ics also in­volves a sig­nif­i­cant fi­nan­cial out­lay. For ex­am­ple, it would take $200- 500 mil­lion to build a large-scale bi­o­log­ics man­u­fac­tur­ing fa­cil­ity ver­sus $30-100 mil­lion to build a small mol­e­cule man­u­fac­tur­ing fa­cil­ity. Sim­i­larly, the cost of de­vel­op­ing a biosim­i­lar for global mar­kets is es­ti­mated to be around $75-150 mil­lion in com­par­i­son to $2-5 mil­lion re­quired to de­velop a generic.

More­over, the end-to-end sup­ply chain man­age­ment from raw ma­te­rial pro­cure­ment till finished goods dis­patch is com­plex, with var­ied tem­per­a­ture re­quire­ments (-200 to 2500C). Once man­u­fac­tured, stor­age and trans­porta­tion of bi­o­log­ics re­quire a ro­bust cold chain in­fra­struc­ture as wide fluc­tu­a­tions in tem­per­a­ture could lower the ef­fec­tive­ness of a prod­uct. Man­ag­ing these com­plex­i­ties also sig­nif­i­cantly add to the costs of a novel bi­o­logic or biosim­i­lar drug.

The costs in­volved in tak­ing a bi­o­logic drug from ‘lab to mar­ket’ are or­ders of mag­ni­tude higher than chem­i­cally syn­the­sized, tra­di­tional non-bi­o­logic gener­ics.

The cap­i­tal-in­ten­sive na­ture of the biopharma busi­ness means that there will be a handful of play­ers in this space. How­ever, im­pos­ing price con­trols may not be the an­swer to mak­ing these drugs af­ford­able as biopharma com­pa­nies need to make con­tin­ued in­vest­ments in man­u­fac­tur­ing fa­cil­i­ties re­quired for bi­o­log­ics. Forced price cuts could make it un­vi­able for these com­pa­nies to op­er­ate and force them to pull out of the mar­ket, thus lim­it­ing choice and in­creas­ing risk of fu­ture sup­ply short­ages.

In­dia will need to ex­plore and im­ple­ment broad ini­tia­tives to bring down the prices of these prod­ucts. Ini­tia­tives to fa­cil­i­tate sig­nif­i­cant bulk pur­chas­ing by the govern­ment in or­der to meet the needs of pa­tients who can­not af­ford bi­o­log­ics\ biosim­i­lars could be a way to bridge the gap and cre­ate the po­ten­tial for sub­stan­tial ad­di­tional sav­ings through elim­i­na­tion of trade markups and through cost ef­fi­cien­cies due to economies of scale. Fis­cal in­cen­tives for R&D-led com­pa­nies work­ing on de­vel­op­ing bio­phar­ma­ceu­ti­cals will also help them de­fray large costs and pass on the re­sult­ing ben­e­fit to pa­tients.

With play­ers like Bio­con, Dr Reddy’s, Zy­dus Cadila, Lupin and In­tas, In­dia has the ca­pa­bil­ity to be a lead­ing player in the area of biosim­i­lars just as it has gained recog­ni­tion as the phar­macy of the world in small mol­e­cule gener­ics. How­ever, this suc­cess can be repli­cated in biosim­i­lars only if lead­ing pharma play­ers are will­ing to make large in­vest­ments in build­ing high-end ca­pa­bil­i­ties for de­vel­op­ing bi­o­log­ics, cou­pled with global scale man­u­fac­tur­ing fa­cil­i­ties. Large-scale ca­pac­i­ties can bring in economies of scale that drive down over­all costs, en­abling us to of­fer af­ford­able ac­cess to biosim­i­lars glob­ally.

COO- Bio­con Bi­o­log­ics

SHREEHAS TAMBE,COO- Bio­con Bi­o­log­ics

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