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Select Strengths of Sandoz Biosimilar Hyrimoz Granted Interchangeability by FDA

May 08, 2024 -- On April 5, 2024, the US Food and Drug Administration (FDA) approved Sandoz’s supplemental biologics license application (sBLA) seeking interchangeability to include the 10 mg/0.1 mL, 20mg/0.2 mL, and 80 mg/0.8 mL strengths in the pre-filled syringe presentation of Hyrimoz® (adalimumab-adaz) for all indications of the reference product, Humira®* (adalimumab), not covered by orphan drug exclusivity.

Additionally, a provisional determination was provided for the 40 mg/0.4 mL strength of the pre-filled syringe presentation. The FDA reviewed the sBLA and deemed that the data package submitted met the FDA’s requirements for interchangeability, but the FDA determined that another biosimilar for this reference product has remaining interchangeable exclusivity for its 40 mg/0.4 mL product. Sandoz expects the FDA to grant the interchangeability designation also to the Sandoz 40 mg/0.4 mL product when that exclusivity expires.

Keren Haruvi, President Sandoz North America, said: “This is a significant milestone in broadening access to this important medicine for the millions of patients living with chronic inflammatory disease in the US. While an interchangeability designation does not mean a better safety and efficacy profile nor a higher quality standard, we recognize it is valued by some stakeholders who are critical to helping Hyrimoz® reach the patients who need – and may benefit - from it.”

As provided by the FDA, biosimilars have no clinically meaningful differences from their reference medicine, which means one can expect the same safety and effectiveness from the biosimilar as one would expect from the reference medicine. Both biosimilars and interchangeable biosimilars meet the same high standards for quality and similarity to the reference product. All biological products are approved only after they meet FDA’s rigorous approval standards.1

The interchangeability designation is a regulatory designation granted by the FDA, which means the 10 mg/0.1 mL, 20mg/0.2 mL and 80 mg/0.8 mL strengths of the pre-filled syringe presentations for Hyrimoz® may now be substituted for the reference product at the pharmacy without the need for consultation with the prescriber (per state laws). This could facilitate a more seamless switch to Hyrimoz from the reference medication.

The interchangeability designation applies to all versions of Hyrimoz® regardless of commercialization arm, including unbranded versions of adalimumab-adaz. The Sandoz Hyrimoz® that is being commercialized by Cordavis, Sandoz’s unbranded version of adalimumab-adaz, and the Hyrimoz® that is being commercialized by Sandoz were all approved by the FDA under the same BLA. As such, the FDA considers them to be the same product, and they only differ in brand or trade name.

*Humira is a registered trademark of AbbVie Biotechnology Ltd.

About Hyrimoz® (adalimumab-adaz)

Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions — including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis — causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.2

INDICATIONS

HYRIMOZ® (adalimumab-adaz) is a tumor necrosis factor (TNF)-blocker indicated for Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. Crohn’s Disease (CD): treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC): treatment of moderately to severely active UC in adult patients. Limitations of Use: Effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa (HS): treatment of moderate to severe HS in adult patients. Uveitis: Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

SELECT IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS and MALIGNANCY

See full prescribing information for complete boxed warning.

SERIOUS INFECTIONS: Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue HYRIMOZ if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting HYRIMOZ. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

CONTRAINDICATIONS: None.

WARNINGS AND PRECAUTIONS: Serious infections: Do not start HYRIMOZ during an active infection. If an infection develops, monitor carefully, and stop HYRIMOZ if infection becomes serious. Invasive fungal infections: For patients who develop a systemic illness on HYRIMOZ, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. Anaphylaxis or serious hypersensitivity reactions may occur. Hepatitis B virus reactivation: Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop HYRIMOZ and begin anti-viral therapy. Demyelinating disease: Exacerbation or new onset, may occur. Cytopenias, pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping HYRIMOZ. Heart failure: Worsening or new onset, may occur. Lupus-like syndrome: Stop HYRIMOZ if syndrome develops.

ADVERSE REACTIONS: Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash.

DRUG INTERACTIONS: Abatacept: Increased risk of serious infection. Anakinra: Increased risk of serious infection. Live vaccines: Avoid use with HYRIMOZ.

This is not the complete list of all the safety information for HYRIMOZ. Please click to see the full Prescribing Information for HYRIMOZ, including Boxed Warnings and Medication Guide.

References

  1. FDA 2022. Review and Approval. Available from: https://www.fda.gov/drugs/biosimilars/review-and-approval [Last accessed: May 2024]
  2. Hyrimoz ®. Prescribing Information. Available at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ac7d061-3380-468c-b077-c05f8dfbc829 [Last accessed: May 2024]

Source: Sandoz

Posted: May 2024

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