Biosimilars
FDA publishes draft strategy on interchangeable biosimilars following 2025 public workshop
The US Food and Drug Administration (FDA) has issued a draft strategy document titled ‘BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document’, following its 19 September 2025 public workshop on the future needs for developing interchangeable biosimilar products. The document fulfils a Biosimilar User Fee Act (BsUFA III) commitment for FY2023–2027 and summarises workshop and docket comments, as well as future directions
EMA recommends approval for biosimilar omalizumab Adcomfo and pertuzumab Pebrilzo
On 17 September 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending marketing authorisation for two biosimilar medicines: Alvotech’s AVT23, Adcomfo (omalizumab), and Biocon’s Pebrilzo (pertuzumab).
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.
