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Bio­con’s Bold In­te­gra­tion: Uni­fy­ing Biosim­i­lars and Gener­ics to Re­de­fine Glob­al Af­ford­able Ac­cess
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1. Biotech has a new company model: A small team, a big check and a few Chinese assets
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Karen Weintraub
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Endpoints’ Kyle LaHucik counted 18 biotechs launched since January 2025 that are structured as NewCos, with small teams, big money and one or two clinical-stage assets in-licensed from China. Read his take here.

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Karen Weintraub
Deputy Editor, Endpoints News
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Bio­con’s Bold In­te­gra­tion: Uni­fy­ing Biosim­i­lars and Gener­ics to Re­de­fine Glob­al Af­ford­able Ac­cess
by Shreehas Tambe
Set­ting the Stage

Health­care sys­tems across the world are un­der grow­ing pres­sure—from ris­ing costs and in­creas­ing dis­ease bur­den to per­sis­tent gaps in ac­cess.

Ad­dress­ing these chal­lenges at scale re­quires sci­en­tif­ic in­no­va­tion along­side in­te­grat­ed, ef­fi­cient mod­els that de­liv­er con­sis­tent sus­tain­able ac­cess and af­ford­abil­i­ty across the con­tin­u­um of care.

Hav­ing spent near­ly three decades help­ing build Bio­con’s glob­al ca­pa­bil­i­ties, I have seen first-hand the re­spon­si­bil­i­ty that comes with scale and sci­en­tif­ic ex­cel­lence. In­spired by our founder Ki­ran Mazum­dar-Shaw’s vi­sion that ac­cess to health­care should nev­er be de­fined by in­come or ge­og­ra­phy, we are com­mit­ted to trans­lat­ing our scale and sci­ence in­to ac­cess for pa­tients and re­silience for health­care sys­tems.

To­day, Bio­con is tak­ing a de­ci­sive step for­ward. By in­te­grat­ing our biosim­i­lars and gener­ics busi­ness­es un­der one uni­fied struc­ture, we are build­ing a plat­form de­signed to ex­pand ac­cess to af­ford­able med­i­cines with greater speed, ef­fi­cien­cy, and reach.

Build­ing a Uni­fied Plat­form for In­creased Ac­cess

Bio­con’s in­te­gra­tion of its biosim­i­lars and gener­ics busi­ness­es, ef­fec­tive as of April 1, cre­ates a glob­al bio­phar­ma en­ter­prise that is unique­ly po­si­tioned to lead in di­a­betes, on­col­o­gy and im­munol­o­gy — ther­a­peu­tic ar­eas with sig­nif­i­cant un­met needs that to­geth­er ac­count for near­ly 40% of glob­al phar­ma­ceu­ti­cal rev­enues.

The in­te­gra­tion re­flects a growth tra­jec­to­ry that has been re­mark­able. Since ac­quir­ing Vi­a­tris’ biosim­i­lars busi­ness, Bio­con has ex­pand­ed its com­mer­cial and op­er­a­tional foot­print to more than 120 coun­tries reach­ing 21 mil­lion pa­tients in the last fis­cal year. These num­bers are the re­sult of a ver­ti­cal­ly in­te­grat­ed, lab-to-pa­tient play­er with glob­al ca­pa­bil­i­ties com­bin­ing R&D, man­u­fac­tur­ing, com­mer­cial ex­e­cu­tion, and a ro­bust port­fo­lio that few com­pa­nies can repli­cate.

Growth in Biosim­i­lars

Biosim­i­lars are re­defin­ing the fu­ture of af­ford­able health­care. Mil­lions of pa­tients who pre­vi­ous­ly faced bar­ri­ers to treat­ment now have ac­cess to life-chang­ing med­i­cines. They rep­re­sent a trans­for­ma­tive op­por­tu­ni­ty to de­liv­er and ac­cess and af­ford­abil­i­ty for mil­lions of pa­tients world­wide. Here in the U.S., biosim­i­lars  have de­liv­ered $56 bil­lion in sav­ings since mar­ket en­try in 2015 and the sales price of a biosim­i­lar is, on av­er­age, 50% less than the ref­er­ence brand bi­o­log­ic price at the time of biosim­i­lar launch. This has led to im­proved ac­cess and af­ford­abil­i­ty for mil­lions al­ready.

Bio­con is at the fore­front of this biosim­i­lar rev­o­lu­tion. In on­col­o­gy, we are mak­ing a mea­sur­able dif­fer­ence. In the U.S., we launched deno­sum­ab biosim­i­lars Bosaya and Aukel­so(orig­i­na­tor names are Pro­lia® and Xge­va®, re­spec­tive­ly) and these prod­ucts were al­so ap­proved by Health Cana­da in April. We re­cent­ly an­nounced our ex­pand­ed R&D pipeline, in­clud­ing the dis­clo­sure of pem­brolizum­ab (orig­i­na­tor name Keytru­da®) and nivolum­ab (orig­i­na­tor name Op­di­vo®) biosim­i­lars, mark­ing our en­try in­to the USD 62 bil­lion glob­al PD‑1 in­hibitor mar­ket. These can­di­dates have the po­ten­tial to re­duce treat­ment costs by 70–90%.

In oph­thal­mol­o­gy, our afliber­cept (Yesafili®) biosim­i­lar will have a U.S. launch in the near term, rep­re­sent­ing growth in an over $8.75 bil­lion space as of 2025, pro­ject­ed to reach $12.6 bil­lion by 2032. In im­munol­o­gy, we con­tin­ue to build our pres­ence through our dom­i­nant biosim­i­lar po­si­tion for ustek­inum­ab (Yesin­tek®), ap­proved by Health Cana­da last year.

Lead­ing the ‘Di­a­besi­ty’ Mar­ket  

With our new­ly in­te­grat­ed biosim­i­lars and gener­ics busi­ness, we are unique­ly poised to lead in the com­bined di­a­betes and obe­si­ty, or ‘di­a­besi­ty’, glob­al epi­dem­ic, a cri­sis af­fect­ing more than 800 mil­lion peo­ple around the globe.

As the world’s fourth-largest in­sulin sup­pli­er, Bio­con has de­liv­ered more than 9.2 bil­lion dos­es and is com­mit­ted to serv­ing one in five in­sulin-de­pen­dent pa­tients world­wide. Its port­fo­lio of reg­u­lar, long-act­ing, and rapid-act­ing in­sulins is backed by con­tin­ued in­vest­ment and ear­ly mar­ket en­try, in­clud­ing U.S. FDA ap­proval of the first in­ter­change­able biosim­i­lar in­sulin glargine in 2021 and in­sulin as­part in 2025.

In the U.S., ac­cess to af­ford­able in­sulin has too of­ten re­mained out of reach for many peo­ple liv­ing with di­a­betes. Bio­con’s na­tion­wide, mul­ti-year part­ner­ship with Civi­ca, Inc. ex­pands ac­cess to af­ford­able in­sulin at a sub­stan­tial re­duc­tion to pre­vail­ing mar­ket prices, so that peo­ple who need it don't have to choose be­tween treat­ment and oth­er es­sen­tial needs. With­in this broad­er na­tion­al frame­work, through Cal­Rx, the State of Cal­i­for­nia be­came the first U.S. state to di­rect­ly con­tract for its own sup­ply of af­ford­able in­sulin.

Im­por­tant­ly, Bio­con is the on­ly com­pa­ny op­er­at­ing glob­al­ly with both biosim­i­lar in­sulins and gener­ic ver­sions of com­plex pep­tides, in­clud­ing GLP-1s. Li­raglu­tide (Bi­olide®) was launched in se­lect Eu­ro­pean coun­tries and ap­proved in the U.S. In late 2025, Bio­con Lim­it­ed signed an agree­ment with Ajan­ta to sup­ply Semaglu­tide to three coun­tries across Africa, Cen­tral Asia, and the Mid­dle East. Com­bin­ing the ef­forts of Bio­con Lim­it­ed and Bio­con Bi­o­log­ics makes us unique­ly po­si­tioned in the grow­ing di­a­besi­ty mar­ket.

An En­vi­ron­ment Primed for Growth

The glob­al biosim­i­lars mar­ket is en­ter­ing a new era of growth, dri­ven by fa­vor­able reg­u­la­to­ry and pol­i­cy de­vel­op­ments. The FDA’s pro­posed guid­ance to elim­i­nate the in­ter­change­abil­i­ty dis­tinc­tion be­tween biosim­i­lars and in­ter­change­able biosim­i­lars is a wa­ter­shed mo­ment, sim­pli­fy­ing the path­way for biosim­i­lar adop­tion at the phar­ma­cy lev­el and ac­cel­er­at­ing ac­cess for pa­tients.

Sep­a­rate­ly, new FDA guid­ance on stream­lin­ing clin­i­cal phar­ma­co­ki­net­ic test­ing could re­duce de­vel­op­ment costs by $100 mil­lion to $300 mil­lion per prod­uct and cut time­lines by up to 50 per­cent. Be­tween 2025 and 2034, 118 bi­o­log­ics will lose patent pro­tec­tion, open­ing a $232 bil­lion mar­ket and pro­vid­ing ac­cess to mil­lions who would not have oth­er­wise af­ford­ed need­ed med­ica­tions. The In­fla­tion Re­duc­tion Act and pend­ing skin­ny la­bel leg­is­la­tion could al­so un­lock an ad­di­tion­al $181 bil­lion in pro­ject­ed sav­ings over the next five years.

Lay­ing the Path for the Fu­ture

The in­te­gra­tion of our gener­ics and biosim­i­lars busi­ness­es is more than a struc­tur­al sim­pli­fi­ca­tion. It is a bold state­ment about the fu­ture of health­care. As pa­tients and health sys­tems world­wide seek greater af­ford­abil­i­ty and broad­er ac­cess, Bio­con’s uni­fied busi­ness mod­el is de­signed to an­swer that call.

An­chored in pa­tient‑cen­tric in­no­va­tion and an un­wa­ver­ing com­mit­ment to af­ford­abil­i­ty, we are well po­si­tioned to lead the next chap­ter of glob­al health­care, ex­pand­ing ac­cess to high‑qual­i­ty med­i­cines and help­ing en­sure that no pa­tient is left be­hind.

To learn more about Bio­con's biosim­i­lars and gener­ics port­fo­lio and its com­mit­ment to im­prov­ing af­ford­abil­i­ty and ex­pand­ing pa­tient ac­cess world­wide, vis­it bio­con.com.

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by Kyle LaHucik

A new fla­vor of com­pa­ny is shak­ing up how biotechs are built.