Extrapolation from Rheumatoid Arthritis Studies
If a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one therapeutic indication, safety and efficacy data may be extrapolated to other indications approved for the reference medicine. This means that fewer clinical trials or no trials at all need to be carried out with the biosimilar in certain indications.
Extrapolation of data to other indications is always supported by scientific evidence generated in robust comparability studies (quality, non-clinical and clinical). For Hulio®, studies on Rheumatoid arthritis (RA) patients was used to extrapolate for other indications.1
Hulio® has been indicated in rheumatologic therapeutic areas such as RA, psoriatic arthritis, ankylosing spondylitis, juvenile Idiopathic arthritis. The recommended dose of Hulio® for adult patients with RA is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Hulio®.2