Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
A version of this article was originally published on The Center for Biosimilars. This version has been lightly edited.
Sandoz said this week the the FDA approved its citrate-free, high-concentration formulation (HCF) of its adalimumab biosimilar, Hyrimoz.
The adalimumab-adaz injection (100 mg/mL) is approved to treat 7 indications covered by the reference product, Humira, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.
“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” Keren Haruvi, president, Sandoz Inc., head of North America, said in a statement.
Sandoz set a launch date of July 1 for both versions of Hyrimoz.
The FDA approval was based on a phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free, HCF 100 mg/mL. This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the low-concentration adalimumab and the HCF adalimumab.
The original, low-concentration version of Hyrimoz was approved by the FDA in 2018. Another HCF version, Hadlima, from Organon and Samsung Bioepis, was approved in August 2022. Biologics license applications for Alvotech and Celltrion Healthcare's high-concentration adalimumab biosimilars are currently under review with the FDA.
In 2023, up to 10 adalimumab biosimilars will enter the market. The first, Amgen’s Amjevita, launched at the end of January 2023; as with Hyrimoz, the others are scheduled to launch starting in July 2023.
The Joint Commission is launching the Rural Health Clinic Accreditation Program to standardize staff training and patient care practices at rural health clinics nationwide; the American Cancer Society recently launched the largest-ever study of cancer risk and outcomes in Black women; the HHS COVID-19 vaccination campaign saved $732 billion by preventing illness and related costs.
Read More
Budesonide-Based Triple Therapy Shows Best Benefit Over Dual Therapy for COPD
May 8th 2024The triple therapy of budesonide, glycopyrrolate, and formoterol fumarate showed the greatest incremental net benefit among a series of triple therapy medications that were evaluated against dual therapy for chronic obstructive pulmonary disease (COPD), according to an analysis presented at ISPOR.
Read More