Biosimilars

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows

Health Canada has approved several new biosimilars referencing Amgen’s Prolia/Xgeva (denosumab) and Janssen’s Stelara (ustekinumab) in the first half of 2026, significantly expanding treatment options for osteoporosis, cancer-related bone conditions, and inflammatory diseases in Canada.

HHS push to ‘genericize’ biosimilars sparks backlash

The US Department of Health and Human Services (HHS), through the US Food and Drug Administration’s (FDA), is launching an initiative to ‘genericize’ biosimilars. Fast-tracking approvals and eliminating key clinical and switching studies represent a radical departure from established global regulatory science.

FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars

Two biosimilars—Zimrixby (rituximab-cdxx) and Garzulys (insulin aspart-fsan)—received US Food and Drug Administration (FDA) approval in July 2026, expanding treatment options in oncology, immunology and diabetes care.

EMA recommends approval for biosimilar pegfilgrastim Cavoley

On 23 July 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Cavoley, a biosimilar pegfilgrastim developed by CuraTeQ Biologics, a subsidiary of Aurobindo Pharma.

FDA approves first interchangeable ranibizumab biosimilar Ranluspec

On 2 June 2026, the US Food and Drug Administration (FDA) has approved Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Roche/Genentech’s Lucentis (ranibizumab). Ranluspec is the first interchangeable biosimilar referencing Lucentis approved in both single-dose vial and single-dose prefilled syringe presentations across its two strengths (0.3 mg and 0.5 mg).

Medicines for Europe calls for Biotech Act reforms to address ‘biosimilar void’

Medicines for Europe has published a comprehensive position paper outlining critical reforms needed in the European Biotech Act to address what it describes as a growing ‘biosimilar void’ threatening patient access, healthcare sustainability, and Europe's strategic autonomy in biotechnology.

Biosimilar interchangeability: a necessary fix, but not a silver bullet

Beyond the FDA, state laws and PBM practices remain key hurdles to broader substitution.

As the US biosimilar market continues to mature, policymakers and regulators are grappling with whether changes to the US Food and Drug Administration's (FDA) interchangeability standards can unlock greater competition and lower biological drug costs. A new analysis published in the American Journal of Managed Care concludes that while reforming these standards is a necessary first step, it is unlikely to be sufficient on its own to transform the biosimilar landscape.

EMA recommends approval for biosimilar Denosumab Ascend and pegfilgrastim Nylaspeg

On 25 June 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of marketing authorizations (MA) for two biosimilar medicines: Ascend’s Denosumab Ascend and Qilu’s pegfilgrastim Nylaspeg.

EULAR 2025 RA guidelines streamlined as biosimilar expansion reshapes treatment sequencing

New 9‑point guidance drops prognostic stratification, accelerates biological access as biosimilars and generics drive cost convergence

The European Alliance of Associations for Rheumatology (EULAR) has released its 2025 update of the management recommendations for rheumatoid arthritis (RA), consolidating the previous 11 recommendations into a streamlined set of 9. 

FDA approves Ennumo as eighth pegfilgrastim biosimilar

On 7 May 2026, the US Food and Drug Administration (FDA) approved Ennumo (pegfilgrastim-pccg), a biosimilar referencing Amgen’s blockbuster Neulasta. The approval adds an eighth competitor to the US pegfilgrastim biosimilar landscape, further intensifying pricing pressures in the supportive oncology care market.

FDA approves first interchangeable golimumab biosimilars Immgolis and Immgolis Intri

On 18 May 2026, the US Food and Drug Administration (FDA) approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), marking the first interchangeable biosimilars to Janssen’s (Johnson & Johnson, J&J) anti-tumour necrosis factor (TNF) therapies Simponi and Simponi Aria. 

EMA recommends approval for ranibizumab biosimilar Vislyfa

Following the European Medicines Agency’s (EMA) positive opinion of Rexatilux ranibizumab biosimilar in April 2026, on 21 May 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Lupin’s ranibizumab biosimilar, Vislyfa, for the treatment of wet macular degeneration.

Biosimilars uptake in Chile: why does it lag behind?

Exploring the barriers to biosimilar adoption in Chile

In Chile, biosimilars uptake is limited, especially for oncology biosimilars. A new study published in GaBI Journal [1] identifies the key barriers to biosimilar adoption in Chile and proposes strategic recommendations to strengthen their value proposition. 

FDA approves third interchangeable insulin glargine biosimilar Langlara

On 30 April 2026, the US Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s Lantus.

EMA recommends approval for ranibizumab biosimilar Rexatilux

On 23 April 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Intas’ ranibizumab biosimilar, Rexatilux, for the treatment of wet macular degeneration.

Japan approves Samsung-Nipro’s ustekinumab biosimilar

In December 2025, Samsung Bioepis and NIPRO announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO' has been granted in Japan.

FDA approves denosumab biosimilar Ponlimsi

On 30 March 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ponlimsi (denosumab-adet), a biosimilar to Amgen’s Prolia and Xgeva (denosumab) [1].

Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections

For millions of people at risk of losing their sight, regular eye injections are a crucial but demanding part of treatment. A new study [1] shows that a biosimilar version of aflibercept can be safely given using a pre-filled syringe, a development that could make these injections faster, safer and more convenient.

EMA recommends approval of three new biosimilars for diabetes and autoimmune conditions

Bysumlog (insulin lispro), Dazparda (insulin aspart), and Fubelv (etanercept) receive positive CHMP opinions

On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for three biosimilar medicines: Bysumlog (insulin lispro), Dazparda (insulin aspart), and Fubelv (etanercept).

EMA recommends approval for pertuzumab and tocilizumab biosimilars

On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for two biosimilar medicines: Henlius’ Poherdy (pertuzumab) and Gedeon Richter’s Tuyory (tocilizumab). Additionally, Henlius marks the first anniversary of the European Commission’s (EC) approval of its novel biological, Hetronifly (serplulimab).

FDA approves filgrastim biosimilar Filkri

On 15 January 2026, the US Food and Drug Administration (FDA) approved the first biosimilar of the year, Accord Biopharma’s Filkri (filgrastim-laha), a biosimilar to Amgen’s Neupogen (filgrastim).

SBR issues position statement on safe originator biological/biosimilar interchangeability

In early 2026, the Biotechnology Committee of the Brazilian Society of Rheumatology published a position statement on ‘the interchangeability of originator and biosimilar biologicals in immune-mediated rheumatic diseases’ in Advances in Rheumatology. This outlines five key recommendations for physicians.

EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec

On 10 February 2026, the European Commission (EC) granted marketing authorization for two biosimilars: Bio-Thera/Stada’s Gotenfia (golimumab); and Lupin/Sandoz’s Ranluspec (ranibizumab), both received the positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 11 December 2025.

OECD study finds no direct link between advertising rules and biosimilar uptake

In December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper titled ‘Assessing the impact of promotion and advertising regulations on biosimilar uptake’ [1].

EMA recommends approval for teriparatide biosimilar Zandoriah

On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion, recommending the granting of a marketing authorization for CinnaGen’s teriparatide biosimilar, Zandoriah, for the treatment of osteoporosis.

FDA approves third interchangeable ranibizumab biosimilar Nufymco

On 18 December 2025, the US Food and Drug Administration (FDA) granted approval to Nufymco (ranibizumab-leyk), an interchangeable biosimilar to Genentech’s Lucentis (ranibizumab). 

FDA approves Poherdy (first interchangeable pertuzumab) and Armlupeg (pegfilgrastim) biosimilars

On 13 November 2025, the US Food and Drug Administration (FDA) approved Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s Perjeta. Additionally, on 28 November 2025, the FDA approved Lupin’s pegfilgrastim biosimilar, Armlupeg (pegfilgrastim-unne).

EMA recommends approval for insulin glargine biosimilar Ondibta and denosumab biosimilar Osqay

On 13 November 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive opinions recommending the granting of a marketing authorization for two biosimilar medicines: Ondibta (insulin glargine), for the treatment of diabetes mellitus; and Osqay (denosumab), for the treatment of osteoporosis and bone loss.

FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus

The US Food and Drug Administration (FDA) approved four denosumab biosimilars in late 2025. The first two, Osvyrti and Jubereq (denosumab-desu), were approved on 29 October 2025, and reference Amgen’s Prolia and Xgeva, respectively. The second pair, Boncresa and Oziltus (denosumab-mobz), were approved on 19 December 2025, and also reference Prolia and Xgeva.

FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma

On 9 October 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron’s Eylea (aflibercept). On 17 October 2025, the FDA approved expanded indications for Celltrion’s Yuflyma (adalimumab-aaty) and its unbranded version.

ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept

In September 2025, ANVISA, the Brazilian Health Regulatory Agency, issued favourable opinions recommending marketing authorization for four biosimilars, including two biosimilars of denosumab, one of trastuzumab, and one of aflibercept [1].

Biosimilars referencing Amgen’s Neulasta and Neupogen launch in Canada and US

Kashiv BioSciences has launched two biosimilars, Pexegra and Filra, in Canada, while Tanvex Biopharma has introduced its biosimilar, Nypozi (filgrastim-txid), to the US market, expanding patient access in North America.

EMA recommends approval for nine biosimilars

On 18 September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for nine biosimilars, including seven denosumab, one golimumab, and one ustekinumab biosimilar medicines. 

FDA approves six denosumab biosimilars

In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone health issues.

EMA recommends approval for four biosimilars targeting three therapies

On 24 July 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for four biosimilars, including two denosumab biosimilar medicines, an aflibercept biosimilar, and an ustekinumab biosimilar.

FDA approves first interchangeable rapid-acting insulin biosimilar, Kirsty

On 15 July 2025, the US Food and Drug Administration (FDA) approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), a biosimilar to Novo Nordisk’s NovoLog (insulin aspart). This approval designates Kirsty as the first and only interchangeable biosimilar for a rapid-acting insulin, a significant milestone in diabetes treatment access.

ANVISA approves ranibizumab and tocilizumab biosimilars

Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has approved biosimilars for Lucentis (ranibizumab) and Actemra (tocilizumab), expanding treatment access for eye diseases and arthritis.

Argentina approves the first biosimilar agalsidase beta for Fabry disease

Argentina has approved Agalzyme, a biosimilar of agalsidase beta, as the first enzyme replacement therapy for Fabry disease in Latin America, representing a major advance in treatment accessibility for this rare disorder.

Hulio granted US interchangeability status

In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to Mylan/Biocon’s biosimilar Hulio (adalimumab-fkjp). This biosimilar joins Samsung Bioepis’ Hadlima (adalimumab-bwwd), and a number of other adalimumab biosimilars, as interchangeable products available in the US market [1].

First pembrolizumab similar biological introduced in Paraguay

Paraguay takes major step forward in access to cancer treatments with first pembrolizumab similar biological.