Indicated for the treatment of chronic inflammatory diseases, the biosimilar medicine adalimumab will be provided free of charge by the Unified Health System (SUS) from December. The drug is indicated for the treatment of dermatological, rheumatological and gastroenterological problems.
The arrival of the biosimilar to the public medicine distribution system takes place through a partnership between Sandoz, a leader in generic and biosimilar medicines, and the Butantan Institute.
“Adalimumab is recommended for the treatment of rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis; dermatological conditions, such as psoriasis and hidradenitis suppurativa; gastroenterological diseases, such as Crohn’s disease, colitis and ulcerative colitis”, detailed Butantan in a note.
To ensure the treatment of patients with the biosimilar, the Ministry of Health outlined a supply plan based on random allocation in state blocks, in order to avoid privileges of choice or clinical condition of the patient. “With this, the expectation is that 30% of the Rede-SUS service quota will receive the first shipment of the medicine produced by Butantan”, pointed out the institute.
The supply of adalimumab occurs through a Partnership for Productive Development (PDP), which is a process of transferring and absorbing technology for drug production by national companies with the aim of expanding access to drugs considered strategic for the SUS.
According to the Butantan Institute, the expectation for the adalimumab PDP is that more than 30,000 Brazilian patients will be positively impacted by access to the drug.
“It should be noted that the indications approved for adalimumab are the same as those for the reference drug Humira®2, approved through an extensive exercise of analytical, preclinical, pharmacokinetic, pharmacodynamic, and phase III clinical comparability, in a sensitive population, with multiple exchanges to ensure that the product has a clinical performance equivalent to the reference medicine in terms of efficacy, safety and immunogenicity”, assured Butantan.
*trainee under the supervision of Bárbara Brambila.
Source: CNN Brasil
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