Biosimilar Hulio Gets FDA Approval

The Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp; Mylan), a biosimilar to Humira® (adalimumab; AbbVie).

Hulio, a tumor necrosis factor (TNF) blocker, is indicated for:

• Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or non-biologic DMARDs.
• Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients ≥4 years old; may be used alone or with MTX.
• Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA; may be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
• Adult Crohn disease (CD): reducing signs/symptoms, inducing and maintaining clinical remission for moderately to severely active CD in adult patients with inadequate response to conventional therapy; reducing signs/symptoms, inducing clinical remission in patients who have also lost response to or are intolerant to infliximab.
• Ulcerative colitis (UC): inducing and sustaining clinical remission for moderately to severely active UC in adult patients with inadequate response to immunosuppressants (ie, corticosteroids, azathioprine, or 6-MP).
• Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The approval of Hulio was based on a comprehensive analytical, preclinical and clinical program, which included the phase 3 ARABESC study that showed no clinically meaningful differences between the biosimilar and the reference product in RA patients, in terms of safety, efficacy and immunogenicity.

Mylan expects to launch Hulio in the US in July 2023. It will be available as a 40mg/0.8mL solution in single-dose prefilled pens and prefilled syringes, as well as a 20mg/0.4mL solution in single-dose prefilled syringes.

For more information visit mylan.com.