Genentech: cross-border access for the specialty portfolio

Quick orientation

Genentech, Inc. is the US pharmaceutical arm of the Roche group, headquartered in South San Francisco, California. Founded in 1976 and acquired in full by Roche in 2009, Genentech is the holder of US FDA approvals and the US wholesale-distribution chain for the Roche Pharmaceuticals portfolio. For Reserve Meds named-patient program purposes, when international patients request "Ocrevus" or "Hemlibra" or "Vabysmo," the operative US entity at the prescription, distribution, and DSCSA-pedigree level is Genentech. The originator company brand is Roche.

Genentech's therapeutic concentration is in oncology and hematology, neuroscience, ophthalmology, and rare disease. The company also holds FDA approval for several long-tenured products that remain reference originators outside the United States despite biosimilar competition (Herceptin, Avastin, Rituxan).

Portfolio in cross-border NPP scope

Ocrevus (ocrelizumab)

Anti-CD20 monoclonal antibody approved for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. The PPMS indication is the cross-border flashpoint: it is the first and remains one of the only FDA-approved therapies for PPMS, and many MENA and India regulatory authorities have either not added the PPMS indication or have restricted reimbursement to relapsing forms only. US WAC at twice-yearly maintenance is approximately $74,000 per year.

Hemlibra (emicizumab)

Bispecific antibody for prophylaxis in hemophilia A with or without factor VIII inhibitors. US WAC at maintenance dosing for an adult patient has historically run at approximately $480,000 per year. Cross-border requests cluster around pediatric hemophilia A patients in MENA and India where the inhibitor-positive subgroup has limited locally reimbursed alternatives and where the subcutaneous weekly or biweekly schedule is preferred over factor VIII intravenous bolus dosing.

Evrysdi (risdiplam)

Oral SMN2 splicing modifier for spinal muscular atrophy in patients two months of age and older. International requests come from SMA pediatric and adult patients where the oral route is preferred over the intrathecal lumbar-puncture burden of nusinersen, or where the gene-therapy alternative (Zolgensma) is not weight-eligible or not locally available.

Vabysmo (faricimab)

Bispecific antibody targeting VEGF-A and Ang-2 for neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. Cross-border demand concentrates in the Gulf and India where retina specialists are adopting extended-interval dosing (up to every 16 weeks) to reduce patient and clinic burden.

Polivy (polatuzumab vedotin)

CD79b-directed antibody-drug conjugate approved as Pola-R-CHP for first-line diffuse large B-cell lymphoma. Cross-border requests cluster around first-line DLBCL patients in MENA where the Pola-R-CHP combination has not yet been added to the local payer formulary.

Columvi (glofitamab)

CD20 and CD3 bispecific T-cell engager for relapsed and refractory DLBCL after two or more prior lines. International requests come from third-line and beyond DLBCL patients in MENA and India.

Kadcyla, Perjeta, Phesgo

The Genentech HER2 franchise. Kadcyla (trastuzumab emtansine) is the antibody-drug conjugate for HER2-positive breast cancer with residual disease after neoadjuvant therapy, and for HER2-positive metastatic disease. Perjeta (pertuzumab) is added to trastuzumab plus chemotherapy in HER2-positive neoadjuvant and metastatic regimens. Phesgo is the subcutaneous fixed-dose combination of pertuzumab and trastuzumab. International requests favor the Phesgo subcutaneous formulation and the adjuvant Kadcyla indication.

Tecentriq (atezolizumab)

PD-L1 inhibitor approved across non-small-cell lung cancer, small-cell lung cancer, hepatocellular carcinoma, urothelial carcinoma, and other indications. Cross-border requests come from oncology patients in MENA where the locally available PD-1 or PD-L1 options have indication-specific gaps that Tecentriq covers.

Xolair (omalizumab)

Anti-IgE monoclonal antibody co-marketed by Genentech and Novartis, approved for moderate to severe persistent allergic asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps, and food allergy. Cross-border requests cluster around the food allergy indication, which is newer and not yet widely locally approved, and around pediatric chronic urticaria.

Why patients route Genentech products through cross-border NPP

The cross-border drivers for Genentech-distributed product overlap closely with the Roche-parent drivers: primary progressive MS and inhibitor-positive hemophilia A are indication-specific gaps; the HER2 oncology adjuvant indications and the Phesgo subcutaneous formulation are local-launch lag cases; the IgE food-allergy indication is too new for most non-US labels.

Genentech Access Solutions and the Genentech Patient Foundation patient assistance programs are restricted to US residents and US prescriptions. International patients route as cash-pay through the named-patient pathway; we set this expectation clearly at intake.

Manufacturer engagement posture

Reserve Meds coordinates Genentech-distributed US product through DSCSA-compliant specialty wholesaler channels. We are not an authorized Genentech distributor; we are an independent named-patient program coordinator. Patient assistance program coverage does not extend to cross-border patients. All Reserve Meds orders are cash-pay at firm-quote pricing.

For Genentech market access, medical affairs, and US-launch international-spillover teams: Reserve Meds maintains structured demand visibility around the products where MENA and India launch sequencing lags US approval. If your group is evaluating named-patient program demand or planning international medical affairs engagement, we are open to a structured conversation under NDA.

Common cross-border destinations for the Genentech portfolio

Ocrevus, Evrysdi, and Hemlibra concentrate in the UAE, Saudi Arabia, India, and Egypt. The HER2 oncology franchise tracks specialist concentration in Saudi Arabia, UAE, India, and Egypt. Vabysmo and Xolair are heaviest in the Gulf and India.

What Reserve Meds provides

For every Genentech product order, Reserve Meds coordinates DSCSA chain-of-custody documentation; cold-chain validated logistics; country regulatory pathway expertise covering named-patient import approval and customs clearance; 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 Genentech product and want a firm quote can start a request below.

Start a request for a Genentech product

Next step for Genentech teams

If you are on the Genentech access, medical affairs, or US international engagement 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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