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Biocon Biologics

Biosimilar developer, India. 9 development products across 9 molecules: aflibercept, bevacizumab, denosumab, insulin aspart, insulin glargine, insulin human, pegfilgrastim, trastuzumab, ustekinumab.

First approval in the Atlas: Oct 2013, CANMAb, trastuzumab (CDSCO)
FDAproducts approved8
EMAproducts approved8
MHRAproducts approved8
PMDAproducts approved1
HCproducts approved7
CDSCOproducts approved5
EDEproducts registered5
Connections
9molecules9products7 of 7markets1candidates in trials8companies on the same molecules

About Biocon Biologics

Biocon is the Indian company that has taken the most products to Western markets. Its trastuzumab was the first in the world, in India in 2013, and the first approved in the United States. Its insulin glargine, Semglee, was the first interchangeable biosimilar of any kind in the United States, and its insulin aspart the first interchangeable aspart. It holds eight US and eight European approvals across nine molecules, seven in Canada, five in the UAE, and one in Japan. Most of its products were originally marketed with Mylan and passed to Biocon when it bought Viatris's biosimilar business.

Portfolio by market

MoleculeProductFDAEMAMHRAPMDAHCCDSCOEDEMarkets
AfliberceptYesafili MYL-1701PMay 2024Sep 2023MHRA·Jun 2025Sep 2025·5/7
BevacizumabJobevne / Abevmy / Krabeva Bmab-100Apr 2025Apr 2021MHRA·Nov 2021May 2017Feb 20226/7
DenosumabBosaya / Aukelso / Vevzuo / Evfraxy Bmab 1000Sep 2025Jun 2025MHRA····3/7
Insulin aspartKirsty MYL-1601DJul 2025Feb 2021MHRA·Oct 2021·Jul 20235/7
Insulin glargineSemglee MYL-1501DJul 2021Mar 2018MHRAMar 2016Apr 2022Aug 2018Aug 20217/7
Insulin humanBiocon human insulin·····Feb 2018·1/7
PegfilgrastimFulphila / Vivlipeg / Biopegfil MYL-1401HJun 2018Nov 2018MHRA·Dec 2018·Feb 20195/7
TrastuzumabOgivri / CANMAb MYL-1401O (Bmab-200)Dec 2017Dec 2018MHRA·May 2019Oct 2013Nov 20186/7
UstekinumabYesintek / Usrenty Bmab 1200Nov 2024Feb 2025MHRA·Oct 2025··4/7

Month shown is the first approval or registration of that product in that market.

Also holds or markets

Products developed by another company for which Biocon Biologics is the licence holder or applicant in one or more markets.

MoleculeBrandMarketHolder or applicantApprovedDeveloper
AdalimumabHulioFDABiocon Biologics Inc.Jul 2020Fujifilm Kyowa Kirin Biologics
AdalimumabHulioHCBiocon Biologics Canada INCNov 2020Fujifilm Kyowa Kirin Biologics
AdalimumabHulioEDETerumo Yamaguchi Corporation for Biocon BiologicsMay 2025Fujifilm Kyowa Kirin Biologics
Epoetin alfa and zetaBiocon (INN only)CDSCOBiocon LimitedAug 2006Not stated in the CDSCO list
EtanerceptMylan Pharmaceuticals Private (INN only)CDSCOMylan Pharmaceuticals Private Limited, now Biocon Biologics LimitedJan 2021Lupin

In development

ClinicalTrials.gov lists two comparative trials sponsored by Biocon Biologics for two molecules: adalimumab, pertuzumab. Candidates without an approval yet in the seven markets: PERT-IJS.

MoleculeCandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionIn the AtlasRegistry record
AdalimumabHulioBiocon BiologicsHumiraPhase 3SwitchingCompletedNov 2022Sep 2023HulioNCT05637515
PertuzumabPERT-IJSBiocon BiologicsPerjetaPhase 3Comparative efficacyTerminatedJan 2025Dec 2025no approval in the seven marketsNCT06038539

Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.

Companies on the same molecules

Developers whose portfolios overlap most with Biocon Biologics, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.

CelltrionFive shared molecules: aflibercept, bevacizumab, denosumab, trastuzumab, ustekinumab10 molecules in its portfolioSamsung BioepisFive shared molecules: aflibercept, bevacizumab, denosumab, trastuzumab, ustekinumab10 molecules in its portfolioAmgenFour shared molecules: aflibercept, bevacizumab, trastuzumab, ustekinumab8 molecules in its portfolioIntas PharmaceuticalsFour shared molecules: bevacizumab, denosumab, pegfilgrastim, trastuzumab12 molecules in its portfolioReliance Life SciencesFour shared molecules: bevacizumab, denosumab, trastuzumab, ustekinumab14 molecules in its portfolioAlvotechThree shared molecules: aflibercept, denosumab, ustekinumab5 molecules in its portfolioApotexThree shared molecules: aflibercept, bevacizumab, denosumab3 molecules in its portfolioCuraTeQ BiologicsThree shared molecules: bevacizumab, pegfilgrastim, trastuzumab4 molecules in its portfolio

Chronology

Compare Biocon Biologics with other developers on the comparison page.

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Data current to September 2026.