Regeneron: cross-border access for the specialty portfolio

Quick orientation

Regeneron Pharmaceuticals, Inc. is a US-headquartered biotechnology company based in Tarrytown, New York. Regeneron's specialty footprint is anchored in ophthalmology (Eylea and Eylea HD), atopic and respiratory immunology (Dupixent co-marketed with Sanofi), oncology (Libtayo PD-1 inhibitor; Lynozyfic in multiple myeloma; Veopoz for CHAPLE disease), cardiovascular (Praluent co-marketed with Sanofi; Evkeeza in homozygous familial hypercholesterolemia), and a growing rare-disease pipeline.

Portfolio in cross-border NPP scope

Eylea and Eylea HD (aflibercept)

VEGF inhibitor approved for neovascular AMD, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity. Eylea HD is the high-dose 8mg formulation for extended-interval dosing. Eylea is co-distributed in the US by Regeneron; outside the US Bayer holds the rights. International requests for the US-distributed product cluster around AMD and DME patients in the Gulf and India seeking the extended-interval Eylea HD dosing.

Dupixent (dupilumab, co-marketed with Sanofi)

IL-4-receptor-alpha monoclonal antibody approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, COPD with type 2 inflammation, and chronic spontaneous urticaria. Cross-border requests cluster around pediatric AD weight-banded dosing, EoE, and the newer COPD and CSU indications not yet locally registered.

Libtayo (cemiplimab)

PD-1 inhibitor approved for advanced cutaneous squamous cell carcinoma, locally advanced or metastatic basal cell carcinoma, advanced cervical cancer, and NSCLC with PD-L1 expression. International requests come from cSCC patients in MENA where the indication has not yet been added locally, and from BCC patients with extensive disease.

Praluent (alirocumab, co-marketed with Sanofi)

PCSK9 inhibitor monoclonal antibody approved for primary hyperlipidemia and HeFH. Cross-border requests cluster in HeFH patients in MENA and India where consanguinity-driven FH prevalence is higher than the global average.

Evkeeza (evinacumab)

ANGPTL3 inhibitor monoclonal antibody approved for homozygous familial hypercholesterolemia in adults and pediatric patients age 5 and older. International requests come from HoFH patients in MENA and India where consanguinity-driven HoFH prevalence is meaningfully higher than the global average and where no locally registered ANGPTL3-targeted therapy exists.

Lynozyfic (linvoseltamab)

BCMA and CD3-directed bispecific T-cell engager approved 2024 for relapsed and refractory multiple myeloma after at least four prior lines. International requests come from triple-class refractory myeloma patients in MENA and India where the BCMA pathway alternatives have been exhausted.

Veopoz (pozelimab)

C5 complement inhibitor monoclonal antibody approved for CHAPLE disease (CD55-deficient protein-losing enteropathy). International requests are by definition very rare but high-acuity: CHAPLE disease is an ultra-rare hereditary disorder.

Why patients route Regeneron products through cross-border NPP

Three patterns dominate. First, the HoFH population in MENA is meaningfully larger than the global average due to consanguinity, and Evkeeza is structurally a cross-border NPP route until local registration completes. Second, Dupixent indication expansion velocity outpaces MENA and India payer formularies. Third, ultra-rare populations (CHAPLE, refractory myeloma) are structurally cross-border. The myRegeneron support program is restricted to US residents.

Manufacturer engagement posture

Reserve Meds coordinates Regeneron-manufactured US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Regeneron distributor. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Regeneron market access teams: Reserve Meds maintains structured demand visibility across ophthalmology, immunology, oncology, and rare-cardiovascular franchises. If your group is sizing pre-registration demand in MENA and India, particularly for the HoFH and ultra-rare populations, we are open to a structured conversation under NDA.

Common cross-border destinations for the Regeneron portfolio

The HoFH and rare-cardiovascular franchise (Evkeeza, Praluent) concentrates in Saudi Arabia, the UAE, Kuwait, and India where consanguinity-driven FH registries are largest. Dupixent demand is broad across the Gulf and India. The ophthalmology franchise tracks retina specialty centers across the region. The oncology and ultra-rare franchises serve tertiary referral centers in the UAE, Saudi Arabia, India, and Egypt.

What Reserve Meds provides

For every Regeneron product order, Reserve Meds coordinates DSCSA chain-of-custody documentation; cold-chain validated logistics where required; country regulatory pathway expertise covering named-patient import approval, customs clearance, and any required physician declaration; and a single patient-facing coordinator. We do not replace the patient's treating physician. A US-licensed pharmacist reviews every prescription before dispensing.

Next step for patients

Patients or caregivers who have a treating physician's prescription for a Regeneron product and want a firm quote can start a request below.

Start a request for a Regeneron product

Next step for Regeneron teams

If you are on the Regeneron access, medical affairs, or international market access team and want to discuss coordinated named-patient program demand from MENA and India, reach us at [email protected]. We will share aggregated demand views under NDA.

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