Licensed indications
Golimumab biosimilar (Gobivaz; Advanz) is licensed for the same indications as the reference product Simponi (Janssen-Cilag). Refer to the individual summary of medicinal product characteristics (SmPC) for further information.
Licensed preparations
Gobivaz (Advanz), will be available as:
Evidence supporting safety and efficacy
Gobivaz is highly similar to the reference product (Simponi). Data show Gobivaz has comparable quality, safety and efficacy to Simponi.
Efficacy data
An unpublished phase 3, double-blind trial (ALVOFLEX; NCT05842213) evaluated 502 patients with moderate to severe rheumatoid arthritis (RA). Patients were randomised to AVT05 (Gobivaz) or the reference product (Simponi), 50mg subcutaneously every 4 weeks. Disease Activity Score-28 for RA using C-reactive Protein (DAS28-CRP) change at week 16 was reported to be within the prespecified equivalence margin (-0.6 to 0.54), demonstrating comparative efficacy. Treatment emergent adverse events at week 16 were similar between groups (38.2% for Gobivaz vs. 39.4% for Simponi). Rates of anti-drug antibodies were also similar (52.7% vs. 57.8%), as were rates of neutralising antibodies (46.6% vs. 47.6%) for Gobivaz and Simponi, respectively.
Extrapolation of data to other indications
Gobivaz is considered highly similar to the reference product (Simponi) based on results of the clinical trial in patients with RA. Its license is extrapolated to the additional indications already approved (licensed) for the reference product (Simponi). Thus, avoiding unnecessary repetition of clinical trials.
Pharmacokinetic trial data
In a published abstract, 336 healthy participants were randomised to a single dose of AVT05 (Gobivaz) or reference product (US or EU Simponi). The study demonstrated primary parameters within pre-specified equivalence margins. Safety and immunogenicity were comparable between products.
Differences between brands
Comparison of pharmaceutical aspects between golimumab biosimilar (Gobivaz) and the reference product (Simponi).
Administration
For commercially available preparations:
- 50mg pre-filled syringe and pre-filled pens
- 100mg pre-filled pens
No differences exist in relation to dose, frequency and administration between golimumab biosimilar (Gobivaz) and the reference product (Simponi).
Golimumab (Simponi and Gobivaz) should be initiated and supervised by a qualified clinician experienced in the diagnosis and treatment for the conditions for which golimumab is indicated. Self-administration, or administration via a caregiver, is acceptable providing this is authorised by a clinician and appropriate training is provided.
Devices
Differences exist between Gobivaz and Simponi pre-filled pens. Ensure patients are appropriately counselled and trained if switching between devices.
Excipients
Simponi uses poloxamer 188 as a surfactant whereas Gobivaz uses polysorbate 80.
All other excipients are identical between Gobivaz and the reference product Simponi.
Sorbitol
Both Gobivaz and Simponi contain sorbitol
Sodium
Sodium is not listed as an excipient; both Gobivaz and Simponi can be considered sodium free.
Synonyms
The following terms are used interchangeably, they do not represent differences in excipient content:
- histidine and L-histidine
- histidine hydrochloride monohydrate and L-histidine monohydrochloride monohydrate
Latex
Differences exist between golimumab products
Simponi
The needle cover on the pre-filled syringe and pre-filled pen is manufactured from dry natural rubber containing latex, and may cause allergic reactions in individuals sensitive to latex.
Gobviaz
Advanz confirmed the needle cover is latex free.
Needle characteristics
Gobviaz – 29G 1/2 inch v-bevel thin wall
Storage and stability
All golimumab products should be stored in a refrigerator (2°C to 8°C). On removal from the refrigerator they can be stored at temperatures of up to 25°C for up to 30 days. Once stored at room temperature the product should not be returned to the fridge.
Additional biosimilar resources
SPS has further resources on biosimilars and biosimilar golimumab.