Biosimilars in development

Current landscape: what is coming for each molecule

What stands out

• Most crowded aheadAdalimumab has the most candidates on the way, nine with no approval yet, followed by bevacizumab (eight) and rituximab (five).
• Nearest to marketOf the 68 unapproved candidates, 36 have reached phase 3, the last trial before a filing, so they are the products most likely to appear in the register over the next two years; 32 are still at the pharmacokinetic stage.
• Most active sponsorsBiocad leads the sponsors with four unapproved candidates, ahead of Generium and AryoGen Pharmed.
• Nothing new comingNo unapproved candidate is visible for golimumab, natalizumab: every trial found there belongs to a product already approved somewhere.
• No trials foundNothing at all was found for teriparatide, somatropin, enoxaparin sodium, agalsidase beta, interferon alfa-2b, which mostly reflects how those products are registered rather than an empty field.

Summary by molecule

Sponsors with unapproved candidates

Ranked by the number of their candidates with no approval yet in the seven markets. Companies with an Atlas page are linked.

A candidate in a phase 3 trial today is a competitor at launch in two to three years. EvySaif builds that view into a regulatory and market-entry assessment for developers weighing a molecule. Regulatory strategy consulting

All trials, molecule by molecule

Ordered by the number of unapproved candidates. Jump to: adalimumab · bevacizumab · rituximab · trastuzumab · denosumab · pertuzumab · etanercept · ranibizumab · insulin human · omalizumab · ustekinumab · aflibercept · epoetin alfa and zeta · abatacept · insulin lispro · vedolizumab · pegfilgrastim · infliximab · eculizumab · tocilizumab · filgrastim · insulin aspart · darbepoetin alfa · follitropin alfa · insulin glargine · golimumab · natalizumab.

Adalimumab

Nine candidates with no approval yet, three of them past phase 3 (Advixa, BCD-057, M923); eighteen products already approved in the seven markets.

Bevacizumab

Eight candidates with no approval yet, four of them past phase 3 (BCD-021, BP102, HD204, TAB008); nineteen products already approved in the seven markets.

Rituximab

Five candidates with no approval yet, four of them past phase 3 (HLX01, MabionCD20, RTXM83, SIBP-02); twelve products already approved in the seven markets.

Trastuzumab

Five candidates with no approval yet, two of them past phase 3 (AryoTrust, SIBP-01); thirteen products already approved in the seven markets.

Denosumab

Four candidates with no approval yet, three of them past phase 3 (Arylia, CMAB807, LY06006); seventeen products already approved in the seven markets.

Pertuzumab

Four candidates with no approval yet, two of them past phase 3 (PERT-IJS, SYSA1901); four products already approved in the seven markets.

Etanercept

Three candidates with no approval yet, two of them past phase 3 (CHS-0214, MB04); seven products already approved in the seven markets.

Ranibizumab

Three candidates with no approval yet, two of them past phase 3 (CKD-701, Incepta ranibizumab); fifteen products already approved in the seven markets.

Insulin human

Three candidates with no approval yet, none past the pharmacokinetic stage; ten products already approved in the seven markets.

Omalizumab

Three candidates with no approval yet, none past the pharmacokinetic stage; three products already approved in the seven markets.

Ustekinumab

Two candidates with no approval yet, one of them past phase 3 (GNR-068); thirteen products already approved in the seven markets.

Aflibercept

Two candidates with no approval yet, two of them past phase 3 (AVT29, QL1207); thirteen products already approved in the seven markets.

Epoetin alfa and zeta

Two candidates with no approval yet, two of them past phase 3 (EPIAO, UB-851); ten products already approved in the seven markets.

Abatacept

Two candidates with no approval yet, none past the pharmacokinetic stage; zero products already approved in the seven markets.

Insulin lispro

Two candidates with no approval yet, two of them past phase 3 (Gan & Lee insulin lispro, Wockhardt insulin lispro); four products already approved in the seven markets.

Vedolizumab

Two candidates with no approval yet, two of them past phase 3 (AVT16, PB016); zero products already approved in the seven markets.

Pegfilgrastim

One candidate with no approval yet, one of them past phase 3 (Eurofarma pegfilgrastim); eighteen products already approved in the seven markets.

Infliximab

One candidate with no approval yet, one of them past phase 3 (CMAB008); seven products already approved in the seven markets.

Eculizumab

One candidate with no approval yet, none past the pharmacokinetic stage; two products already approved in the seven markets.

Tocilizumab

One candidate with no approval yet, one of them past phase 3 (Complarate); six products already approved in the seven markets.

Filgrastim

One candidate with no approval yet, none past the pharmacokinetic stage; twelve products already approved in the seven markets.

Insulin aspart

One candidate with no approval yet, one of them past phase 3 (I004); five products already approved in the seven markets.

Darbepoetin alfa

One candidate with no approval yet, none past the pharmacokinetic stage; six products already approved in the seven markets.

Follitropin alfa

One candidate with no approval yet, one of them past phase 3 (QL1012); five products already approved in the seven markets.

Insulin glargine

One candidate with no approval yet, none past the pharmacokinetic stage; twelve products already approved in the seven markets.

Golimumab

All one candidate in these trials already has an approval somewhere in the seven markets.

Natalizumab

All one candidate in these trials already has an approval somewhere in the seven markets.

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.

Sources

• S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)