Lupin biosimilars: FDA nod, EU CHMP boost in 2025

FDA approval for Armlupeg: what Lupin announced

Lupin Limited said the US Food and Drug Administration (USFDA) approved its biosimilar product Armlupeg (pegfilgrastim-unne). The company described the product as a biosimilar to Amgen’s Neulasta (pegfilgrastim) injection. The approved dosage form is a 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe presentation. Lupin’s statement also noted that the product will be manufactured at its biotech facility in Pune. The company added that this Pune facility was inspected by the USFDA prior to the approval.

What Armlupeg is used for

According to Lupin, Armlupeg is indicated to decrease the incidence of infection, as manifested by febrile neutropenia. The indication applies to patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. This places the product in a clinically important supportive-care category used alongside chemotherapy regimens. For investors tracking Lupin’s complex generics and biosimilars strategy, the approval adds a US-commercializable biosimilar to the company’s portfolio. The disclosure focused on the approval and manufacturing site, without providing launch timing or revenue guidance.

Prior US regulatory step: FDA acceptance of pegfilgrastim aBLA

Separately, Lupin also said the USFDA accepted its aBLA for a proposed pegfilgrastim biosimilar referencing Neulasta. The company reported that the submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic, and immunogenicity studies. Lupin described this as an important filing milestone in the US biosimilars pathway. The company shared a CEO comment in the source text, but the quotation was incomplete in the provided material and is therefore not reproduced here.

Licensing structure in the US: deal with Valorum Biologics

Lupin also entered an exclusive licensing agreement with Valorum Biologics for its pegfilgrastim biosimilar Armlupeg in the US. Under this agreement, Lupin will manufacture and supply the product. Lupin said it will earn upfront and royalty payments under the arrangement, although no amounts were disclosed. The structure indicates that commercialization responsibilities can be shared, while Lupin retains manufacturing and supply linkage. Such licensing frameworks are common in the US biosimilars market, where sales access, contracting, and distribution capabilities matter.

Europe update: CHMP backs Ranluspec ranibizumab biosimilar

On December 17, 2025, Lupin announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for Ranluspec, its biosimilar ranibizumab. The company said the CHMP opinion covered both vial and pre-filled syringe presentations. Lupin listed multiple retinal indications for the product, covering wet age-related macular degeneration and several diabetic and vascular retinal conditions. The CHMP opinion is a key step in the EU’s centralized process, but it is not the final approval.

Indications Lupin listed for Ranluspec

Lupin said Ranluspec’s indications encompass treatment of patients with:

• Neovascular (wet) age-related macular degeneration (AMD)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic macular edema (DME)
• Proliferative diabetic retinopathy (PDR)
• Choroidal neovascularization (CNV)

The company’s disclosure reflects a broad label scope aligned to ranibizumab’s established therapeutic use in ophthalmology. It also highlights the commercial relevance of delivery options (vial and pre-filled syringe) for clinical adoption and hospital procurement.

Clinical and analytical basis cited for the CHMP opinion

Lupin said the positive CHMP opinion is based on a demonstration of similarity to the reference product. The company highlighted an analytical similarity assessment and a 600-patient global phase III clinical trial in patients with neovascular AMD. Lupin said the trial was conducted across the US, EU, Russia, and India. These details matter because EU biosimilar decisions rely on a totality-of-evidence approach, with analytical comparability and confirmatory clinical data forming the core.

What happens next in the EU, and who will commercialize

Lupin said the CHMP positive opinion will now be considered by the European Commission (EC). If approved, the EC will grant a centralized marketing authorization for EU member countries. Lupin also said that, as per a recently announced agreement, the product will be commercialized by Sandoz Group AG across the European Union, excluding Germany. Earlier context also referenced commercialization via Sandoz and Biogaran in select markets. The company’s statements position Lupin as a developer and manufacturer with partners supporting commercialization in Europe.

Manufacturing and compliance signals: USFDA EIR for Nagpur

In another compliance-related update, Lupin said it received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the USFDA for its Nagpur injectable facility. The company linked this outcome to a September 2025 inspection. Lupin said the status supports the plant’s readiness for US supply. For regulated markets, inspection outcomes can directly affect supply reliability and the pace at which product portfolios scale.

Generic pipeline alongside biosimilars: tentative nod for Siponimod

Lupin also disclosed it obtained tentative USFDA approval for Siponimod tablets. The company described it as a generic version of Mayzent to treat relapsing forms of multiple sclerosis. Lupin said the product is to be manufactured at its Pithampur site. A tentative approval typically indicates the application meets regulatory requirements but final approval may depend on market exclusivity or patent-related timing, though Lupin’s statement did not provide further details.

Timeline: Lupin’s key regulatory milestones cited

Analysis: why these developments matter for Lupin

Taken together, the updates show Lupin progressing on two fronts: US biosimilars and EU ophthalmology biosimilars, while also moving select complex generics through the US pipeline. The Armlupeg approval and the acceptance of the pegfilgrastim biosimilar application highlight Lupin’s work in biosimilars supported by analytical and clinical comparability packages. In Europe, the CHMP opinion for Ranluspec signals that Lupin’s ranibizumab program is approaching centralized authorization, with Sandoz positioned to commercialize in most of the EU. And the VAI outcome for the Nagpur injectable facility is a compliance marker that Lupin itself linked to readiness for US supply.

Conclusion

Lupin’s recent announcements centered on regulatory momentum: FDA approval for Armlupeg, FDA acceptance of its pegfilgrastim biosimilar filing, and a positive CHMP opinion for Ranluspec in the EU. The next EU step, as Lupin noted, is the European Commission’s review for a centralized marketing authorization. In the US, Lupin has also pointed to manufacturing preparedness through facility inspection outcomes and to additional pipeline movement through tentative approvals in complex therapies.