The First Biosimilar Medicine From The Partnership Between Sandoz And Butantan Institute Arrives At SUS

Indicated for the treatment of chronic inflammatory diseases², the biosimilar drug adalimumab will be available free of charge to patients from December

São Paulo /PRNewswire/ - Sandoz, a global leader in generic and biosimilar medicines³, in partnership with the Butantan Institute, is now supplying the biosimilar medicine adalimumab to the Ministry of Health. With this, from December 2022, patients of the Unified Health System (SUS) will have access to treatment for free. The initiative is the result of the Partnership for Productive Development (PDP) between the two institutions, signed in December 2021. Adalimumab² is recommended for the treatment of rheumatological diseases, such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and ankylosing spondylitis; dermatological, such as psoriasis and hidradenitis suppurativa; gastroenterological conditions, such as Crohn's disease, colitis and ulcerative colitis.

Aiming to ensure the treatment of patients using adalimumab in Brazil, the Ministry of Health developed a supply plan based on random allocation in state blocks – avoiding privileges of choice or clinical condition of patients. With this, the expectation is that 30% of the Rede-SUS service quota will receive the first shipment of the medicine produced by Butantan.

PDP
The Partnership for Productive Development (PDP) is a process of transferring and absorbing technology for drug production by national companies and its main purpose is to expand access to drugs and products considered strategic for the SUS. PDPs also allow for the strengthening of the country's economic and industrial health complex, since the production of these drugs becomes local. The expectation for the adalimumab PDP is that more than 30,000¹ Brazilian patients will be positively impacted by access to the drug.

“We are very happy to continue the partnership between the Butantan Institute and Sandoz, starting to supply adalimumab to the Ministry of Health. obtains cost savings by no longer depending on the import process. Consequently, this value can be redirected to other health demands, avoiding overloading the system (public and private) and allowing more and more patients to be treated", says Marcelo Belapolsky , Country Head of Sandoz do Brasil.

Monoclonal Antibody Factory
One of the most modern plants in the Butantan industrial park, which was built in just 18 months, is the Monoclonal Antibodies Production Factory (PAM), where high-cost drugs for cancer and autoimmune diseases will be produced. The agreement with the pharmaceutical company Sandoz establishes the transfer of technology within a specified period, making Butantan, as a public laboratory, capable of manufacturing monoclonal antibodies in Brazil and, consequently, able to supply the drug completely or independently to the Ministry of Health.

Safety and effectiveness
It should be noted that the indications approved for adalimumab are the same as for the reference drug Humira® ² , approved by an extensive exercise ⁴ of analytical, preclinical, pharmacokinetic, pharmacodynamic comparability and phase III clinical studies, in a sensitive population, with multiple exchanges to ensure that the product has clinical performance equivalent to the reference medicine in terms of efficacy, safety and immunogenicity.

Sandoz was the first pharmaceutical company to receive approval for a biosimilar in Europe, Japan, Canada and the United States. The company's biosimilars have been used in clinical practice for 15 years, are available in over 100 countries and reach more than 970 million patient-days of treatment exposure ⁵.

Cuidar+ program offers support to patients
In addition to being a pioneer in the development of biosimilar medicines, Sandoz works to offer all the necessary support to patients who use its drugs. Through the Cuidar+ program, SUS patients can obtain benefits such as: educational materials, application support and a call center for queries.

Patients also have an exclusive service channel responsible for active Pharmacovigilance and for monitoring all stages of treatment, ensuring correct adherence. Assistance can be provided by calling 0800-770 1256, option 2, or by email, atendimentomais@suporteaopaciente.com.br .

For more information on the purchase and supply of adalimumab 40 mg syringe - injectable solution by the Ministry of Health, visit: www.gov.br/saude/pt-br .

References:
1.: Data SUS. Available in: 🇧🇷 Accessed on: 12 Aug. 2022.
2.: Hyrimoz® - Product leaflet. Available in: 🇧🇷 Accessed on: 12 Aug. 2022.
3.: What We Do. Available in: . Acesso em: 12 ago. 2022.
4.: Wiland P, Jeka S, Dokoupilová E, Brandt-Jürgens J, Miranda Limón JM, Cantalejo Moreira M, et al. Switching to biosimilar sdz-adl in patients with moderate-to-severe active rheumatoid arthritis: 48-week efficacy, safety and immunogenicity results from the phase iii, randomized, double-blind admyra study. BioDrugs. 2020 Dec;34(6):809–23.
5.: Disponível em: < https://www.sandoz.com.br/nosso-trabalho/biossimilares/biossimilares-sandoz>. Acesso em: 12 ago. 2022.

About Instituto Butantan
Instituto Butantan is the largest producer of vaccines and serums in Latin America and a world reference in efficiency and quality. It is also the main producer of immunobiologicals in Brazil, responsible for a large percentage of the production of hyperimmune sera and a large volume of the national production of vaccine antigens, which make up 65% of the immunizers used in the National Immunization Program (PNI) of the Ministry of Health . During the SARS-CoV-2 virus pandemic, the institute provided more than 112 million doses of the CoronaVac vaccine, which helped save millions of lives in Brazil. Butantan is responsible for supplying 100% of vaccines against the Influenza virus to the PNI. The institute is also able to export the product to other countries, thanks to the inclusion of the vaccine in the list of pre-qualified vaccines by the World Health Organization (WHO), in early 2021. We also export anti-diphtheria and anti-venom serums to 10 countries in the Americas and Europe. The Butantan Institute has been working for 121 years at the service of life and public health in Brazil and the world.

About Sandoz 
Sandoz, a division of Novartis, is a global leader in generic and biosimilar medicines. Our goal is to pioneer patient access by developing and commercializing new, affordable approaches that address unmet medical needs. Our ambition is to be the world's leading and most valuable generics company. Our broad portfolio of high-quality drugs, covering all major therapeutic areas, represented 2020 sales of $9.6 billion.