News | July 27, 2018

Sandoz Receives European Commission Approval For Biosimilar Hyrimoz (Adalimumab)

  • Biosimilar Hyrimoz (adalimumab) approved for use in all same indications as reference medicine*** including rheumatology, gastroenterology and dermatology
  • Early therapeutic intervention is essential in rheumatoid arthritis, supporting urgency of treatments like Hyrimoz
  • Fourth Sandoz biosimilar approved in Europe** in past 18 months, and seventh in total, underscoring Sandoz commitment to making access happen through a robust portfolio

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, recently announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (adalimumab) for use in all indications of the reference medicine***, including rheumatoid arthritis, plaque psoriasis, Crohn's disease, uveitis and ulcerative colitis.[1],[2]

Rheumatoid arthritis alone affects up to 1% of people in the European Union. Patients with moderate to severe rheumatoid arthritis can have chronic inflammation that causes fatigue, pain and joint stiffness. Symptoms can be reversible with appropriate treatment, however the joint damage and the resulting disability are permanent.[3] The introduction of biosimilars has been shown to improve access to advanced treatment options, such as biologic medicines.[4]

"We believe in making access happen for patients who are suffering from chronic inflammatory diseases. Earlier and expanded access to important, disease-modifying, biologic medicines can fundamentally change how patients manage their health," said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. "Biosimilars such as Hyrimoz can also play a transformational role in healthcare system sustainability - so we look forward to making Hyrimoz, and other important biosimilar medicines, broadly available."

The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic. No meaningful clinical differences were observed.[5]-[7]

Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Hyrimoz is the company's seventh approved biosimilar medicine in Europe. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020.

About Hyrimoz (adalimumab)
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 can be a potentially appropriate treatment option for certain patients across a variety of indications. Hyrimoz works by targeting and blocking the protein that contributes to disease symptoms.[1]

References:

[1]   European Medicines Agency. Hyrimoz. Key Facts. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004320/smops/Positive/human_smop_001301.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human. Accessed June 19, 2018.

[2]   European Medicines Agency. Hyrimoz. Summary of Product Characteristics: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004320/smops/Positive/human_smop_001301.jsp&mid=WC0b01ac058001d127.

[3]   European Medicines Agency.http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/12/news_detail_002667.jsp&mid=WC0b01ac058004d5c1. Accessed July 5, 2018.

[4]   European Commission Consensus paper - What you need to know about biosimilar medicines: http://ec.europa.eu/DocsRoom/documents/8242. Accessed July 2, 2018.

[5]   Blauvelt A. A randomized, double-blind, multicenter study to compare the efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (GP2017) with originator adalimumab Poster #5224 presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting, 3-7 March 2017.

[6]   Blauvelt A. Long-Term Efficacy, Safety and Immunogenicity Results from a Randomized, Double-Blind, Phase III Confirmatory Efficacy and Safety Study Comparing GP2017, a Proposed Biosimilar, with Reference Adalimumab [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.

[7]   Jauch-Lembach J. Randomized, Double-Blind, Single-Dose, Three-Arm Parallel Trial to Determine the Pharmacokinetics and Safety of GP2017, EU- and US-Adalimumab in Healthy Male Subjects [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). American College of Rheumatology (ACR) Annual Meeting, US, 3-9 November 2017.

**Humira (adalimumab) is marketed by AbbVie Deutschland GmbH & Co. KG in Europe and Humira is a registered trademark of AbbVie Biotechnology, Inc.

*Hyrimoz is only available as 40 mg pre-filled syringe / pre-filled pen. Thus, it is not possible to administer Hyrimoz to pediatric patients that require less than a full 40 mg dose. If an alternate dose is required, other adalimumab products offering such an option should be used.

**European Commission decisions on the authorization of medicines are valid throughout the 31 countries of the European Economic area, which comprises the 28 member countries of the European Union plus Norway, Iceland and Liechtenstein. That governing body bases its decisions on scientific assessments by the Committee for Medicinal Products for Human Use (CHMP), a subgroup of the European Medicines Agency (EMA).

SOURCE: Sandoz