Mylan launches Hulio (adalimumab), its first biosimilar in Spain. Adalimumab is an injectable biologic drug that inhibits Tumor Necrosis Factor (TNF) and is indicated for the treatment of a variety of rheumatic, dermatological and gastroenterological autoimmune diseases. The introduction in the Spanish market occurs after the approval received by the European Commission (EC) in September 2018, and represents a milestone for the company in improving access to biosimilars in the market. Hulio is part of the portfolio of 20 biosimilars that Mylan currently has in the market or in development.
The approval of the EC was based on the Phase I and Phase III ARABESC studies, carried out by its partner, Fujifilm Kyowa Kirin Biologics1. For at least three months, 728 patients with moderate to severe active rheumatoid arthritis (RA) who were not adequately controlled with methotrexate (MTX) were randomized in a 1: 1 ratio and received Hulium 40 mg / 0.8 ml or the reference product 40 mg / 0.8 ml in combination with MTX every two weeks.
The number of patients with an ACR20 response rate (international criteria for response to treatment) was similar at week 24 in both groups of patients (74.4% Hulio, versus 75.7% in the reference product), which indicates a comparable efficacy profile between both products. In the system for measuring activity of the disease, DAS28-CRP, this was similar at week 24 in both groups of patients (3.43 Hulium vs. 3.42 in the reference product). Serious adverse events occurred in only a few patients in both groups without significant differences (4.1% in Hulium versus 5.2% in the reference product)1.
The effectiveness and safety data of the clinical trial in an indication, in this case the patients with RA, are sufficient evidence of the effectiveness of Hulio to extend the approval to all indications of the reference product. Thus, in addition to the approval for the indication of rheumatoid arthritis, Hulio has also received approval for other indications such as Crohn's disease and psoriasis following extrapolation criteria.
The reference product, Humira, is the best-selling biological medicine in the world. In the last twelve months, until July 31, 2018, achieved in Europe, according to IQVIA, sales of around 4,400 million dollars (about 3,800 million euros).
Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Mylan to market Hulio in Europe. The approval of Hulio by the EC applies to the 28 member countries of the European Union (EU) and Norway, Iceland and Liechtenstein.
The general director of Mylan Spain, Dr. Christophe Maupas, has indicated that "rheumatoid arthritis affects some 300,000 people in Spain2, while it is estimated that there are between 84,000 and 120,000 people affected by Inflammatory Bowel Disease (42% of the they would suffer from Crohn's disease)3. In addition, 2.3% of the Spanish population suffers from psoriasis4.
The arrival of Hulio to Spain "responds to our firm commitment to the health of the Spanish population and to the sustainability of the National Health System, facilitating that it can make investments in favor of innovation and patient care, and confirms a differentiating strategy of the company that is betting to lead the segment of biosimilars, since Hulio is the first of a score of biosimilars that are in development", adds Dr. Maupas.
In addition, stresses that "Hulio has a retractable needle in the syringe, which reduces the risk of accidental puncture after use; the body of the syringe is made of plastic and not glass, which improves its safety in case of falls; or that the dispenser of the pen is by pressure and not through a button, which benefits the lack of mobility in the hand ".
- Alten R et al., Efficacy and safety results of a phase III study comparing fkb327, and alimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis, OP0021, EULAR 2017
- Prevalence of Rheumatic diseases in adult population in Spain. Episer 2016 study. Annals of the Rheumatic Diseases 2018; 77 (Suppl 2): 535.
- Intestinal Inflammatory Disease: current situation and care challenges. EY 2016.
- Psoriasis in 10 responses. Spanish Academy of Dermatology and Venereology. Website: https://aedv.es/la-academia/