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Lupin Secures U.S. FDA approval for Ranluspec (ranibizumab) biosimilar in vial and PFS formats

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June 2026 | Jack Overell – Head of Production, SAE Media Group

Lupin Limited has received U.S. Food and Drug Administration (FDA) approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Lucentis (Genentech), marking a further expansion of its biosimilars portfolio.

Ranluspec is the only interchangeable ranibizumab biosimilar currently approved in the United States in both vial and pre-filled syringe (PFS) formats, offering flexibility across clinical settings and ophthalmology workflows.

Dual Presentation Supports Clinical Efficiency

The product is approved in both 0.3 mg and 0.5 mg strengths – aligned with the reference product – and is available in single-dose vials and PFS configurations.

The availability of a pre-filled syringe format is particularly relevant for high-volume ophthalmology practices, where streamlined preparation and consistent dosing can support procedural efficiency and reduce handling steps.

For drug delivery stakeholders, the approval underscores the continued importance of presentation formats in improving administration workflows and supporting broader adoption of biologics.

Targeting Key Retinal Diseases

Ranibizumab is a recombinant monoclonal antibody fragment that inhibits vascular endothelial growth factor A (VEGF-A), a key driver of abnormal blood vessel growth in the eye.

The biosimilar is indicated for multiple retinal conditions, including:

  • Neovascular (wet) age-related macular degeneration (AMD)
  • Diabetic macular edema (DME)
  • Diabetic retinopathy (DR)
  • Macular edema following retinal vein occlusion (RVO)
  • Myopic choroidal neovascularization (mCNV)

These indications mirror those of Lucentis, reinforcing its role as a direct therapeutic alternative.

Interchangeability and Market Access

Ranluspec has been granted interchangeable biosimilar status, which allows pharmacists – subject to state laws – to substitute the product for the reference drug without prescriber intervention.

This regulatory designation is expected to support uptake by improving access to anti-VEGF therapies and enabling cost-competitive treatment options in ophthalmology.

Strengthening Lupin’s Biosimilars Strategy

The approval represents Lupin’s second biosimilar in the U.S. market and highlights its continued investment in complex biologics.

Company leadership emphasized that the milestone reflects progress in biologics development and manufacturing, while supporting the expansion of more affordable treatment options for patients with vision-threatening conditions.

Implications for PFS and Drug Delivery Innovation

The inclusion of both vial and pre-filled syringe formats reinforces the strategic importance of drug-device combination approaches in biologics delivery. For the PFS and injectable drug delivery (IDD) space, the approval highlights:

  • Growing demand for ready-to-administer biologic formats
  • Increasing focus on workflow efficiency in high-volume clinical environments
  • The role of delivery platforms in differentiating biosimilar products

As biosimilar competition intensifies across ophthalmology and other therapeutic areas, delivery format and ease of administration are likely to play a greater role in driving adoption.



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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