ustekinumab biosimilar available in town and hospital

Résumé

WEZENLA (ustekinumab) is a biosimilar medicine of STELARA.

The range consists of:

three specialties available in town, in subcutaneous injection solution (SC): WEZENLA 45 mg in vial, and WEZENLA 45 mg and 90 mg in ready-to-use pre-filled syringe;
of a specialty reserved for hospitals: WEZENLA 130 mg concentrate for intravenous (IV) infusion.

In the city, WEZENLA is indicated in the treatment of plaque psoriasis in adults and children aged 6 and over, psoriatic arthritis in adults and Crohn’s disease in adults.

The hospital form is only indicated in the treatment of Crohn’s disease.

In pediatrics in children weighing less than 60 kg, the dose to be injected is less than 45 mg; WEZENLA 45 mg in vial must be prescribed. Presentation in a pre-filled syringe is not suitable in this situation.

WEZENLA is approved for use in communities and is reimbursed at 65% on prescriptions for exceptional medicines. The prescription is restricted. The same price applies to the three specialties available in town.

WEZENLA 130 mg IV is for hospital use only.

LThe drug WEZENLA (ustekinumab) is a biosimilar of STELARA. It is included on the reference list of similar biological groups of the National Agency for the Safety of Medicines and Health Products (ANSM).

The WEZENLA range is made up of 4 specialties:

in town and in hospital, as a subcutaneous injection solution (SC):
in hospital only:

Compared to the reference medicine STELARA, as of October 14, 2024:

there is no pre-filled pen presentation;
WEZENLA has no indication in the treatment of ulcerative colitis.

Therapeutic indications: dermatology, rheumatology and gastroenterology

As a reminder, ustekinumab is a monoclonal antibody that inhibits the activity of interleukins 12 and 23.

The therapeutic indications for WEZENLA 45 mg and 90 mg in the treatment of psoriasis in adults and children, psoriatic arthritis and Crohn’s disease are identical to those of STELARA 45 mg or 90 mg (cf. Box 1). Dosage recommendations are defined according to each indication and the patient’s weight.

The therapeutic indication of WEZENLA 130 mg IV in the treatment of Crohn’s disease is identical to that of STELARA 130 mg IV.

**Box 1 – Therapeutic indications for WEZENLA (October 14, 2024)**
WEZENLA 45 mg in vial and prefilled syringe and WEZENLA 90 mg in prefilled syringe: Dermatology in adults: treatment of moderate to severe plaque psoriasis in adults who have not responded, or who have a contraindication, or who are intolerant to other systemic treatments including cyclosporin, methotrexate (MTX) or puvatherapy (psoralen and UVA); in pediatrics: treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 years and over, in the event of insufficient response or intolerance to other systemic treatments or phototherapies. Rheumatology alone or in combination with methotrexate (MTX), in the treatment of active psoriatic arthritis (PsA) in adults when the response to a previous non-biological disease-modifying antirheumatic treatment (DMARD) has been inadequate. WEZENLA 45 mg in vial and prefilled syringe, WEZENLA 90 mg in prefilled syringe and WEZENLA 130 mg IV: Gastroenterology treatment of moderately to severely active Crohn’s disease in adult patients with insufficient response, loss of response or intolerance to conventional treatment or anti-TNFα therapy, or who have a medical contraindication to these treatments.

A presentation in a bottle to respect the dosage in pediatrics

In the treatment of pediatric plaque psoriasis, the dosage of ustekinumab depends on body weight.

In children weighing 60 kg and over, a dose of 45 mg or 90 mg is recommended; the specialties WEZENLA 45 mg and 90 mg are adapted to this dosage and can be prescribed.

In children weighing less than 60 kg, doses less than 45 mg are required (0.75 mg/kg). In this population, only WEZENLA 45 mg vial should be prescribed.

A pre-filled syringe ready to use

The injection can be carried out by the patient himself or a loved one, subject to the agreement of the prescriber and prior training.

WEZENLA is administered subcutaneously (SC) into the upper thigh, buttocks or abdomen, or into the upper arm if the injection is not performed by the patient themselves.

The WEZENLA pre-filled syringe is ready to use. The cap covering the needle should be removed just before (cf. Illustration).

The pre-filled syringe or vial should be removed from the refrigerator 30 minutes before injection to allow the injection solution to return to room temperature.

The vial and pre-filled syringe are for single use only.

Illustration – Prefilled syringe of WEZENLA

(cf. page 98 of the Summary of Product Characteristics)

After the injection, the needle ends up in the needle shield.

Storage instructions

WEZENLA should be stored in the refrigerator, between 2 and 8°C.

The pre-filled syringe or vial can be stored at room temperature up to 30°C for a single period of up to 30 days in the original carton, protected from light. In this case, the following instructions apply:

write on the box the date it was taken out of the refrigerator and the expiration date;
do not return the pre-filled syringe or vial to the refrigerator after a period of storage at room temperature (up to 30°C).

Administrative identity

WEZENLA 45 mg et 90 mg:

List I
Prescription reserved for specialists and services in dermatology, hepato/gastroenterology, internal medicine and rheumatology
WEZENLA 45 mg, 0.5 mL unit vial, CIP 3400930295489
WEZENLA 45 mg, box of 1 prefilled syringe of 0.5 mL, CIP 3400930295496
WEZENLA 90 mg, box of 1 syringe prefilled with 1 mL, CIP 3400930295502
Reimbursable at 65% on exceptional medication prescription [1] (cf. Box 2)
Public price including tax = 1,257.19 euros (identical price for the three specialties) [2]
Approval for communities [3] (cf. Box 2)
Registration on the reference list of similar biological groups
Amgen Laboratory

WEZENLA 130 mg IV:

List I
Reserved for hospital use
Prescription reserved for specialists in gastroenterology and hepatology or internal medicine
Single bottle, CIP 3400955101918, UCD 3400890040471
Approval for communities [4] (cf. Box 2)
Coverage in addition to hospitalization benefits [5] (cf. Box 2)
Registration on the reference list of similar biological groups
Amgen Laboratory

**Box 2 – Scope of WEZENLA support**
For WEZENLA 45 mg prefilled vial and syringe and WEZENLA90 mg prefilled syringe: Plaque psoriasis in adults (indication identical to that of the marketing authorization (AMM): Treatment of moderate to severe plaque psoriasis in adults in the event of failure, or contraindication, or intolerance to other systemic treatments including cyclosporin, methotrexate or puvatherapy. Psoriatic arthritis (indication identical to that of the Marketing Authorisation): Treatment of active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic therapy (DMARD) has been inadequate. Plaque psoriasis in the pediatric population : treatment of severe chronic plaque psoriasis in children aged 6 to 11 years, defined by (restricted indication compared to that of the Marketing Authorization): failure (insufficient response, contraindication or intolerance) to at least two treatments among non-biological systemic treatments and phototherapy; and an extensive form and/or significant psychosocial impact. For all WEZENLA specialties: Adult Crohn’s disease (indication identical to that of the Marketing Authorisation): Treatment of moderate to severe active Crohn’s disease in patients who have failed (insufficient response, loss of response or intolerance) of conventional treatment (corticosteroids or immunosuppressants) and at least one anti-TNFα or who have contraindications to these treatments.