The latest from Brazilian Pharma, including the controversial proposal to transform Brazil’s regulatory agency, ANVISA; Ease Labs’s canabidiol approval, Biolab’s international expansion ambitions and Eurofarma’s multiple myeloma deal.
ANVISA’s autonomy challenged by Congress (Regulatory Focus)
After the swearing in Brazilian’s President Luiz Inácio Lula da Silva earlier this year, a voting block in Brazil’s congress made a surprise attempt to curb the powers of several powerful and highly autonomous agencies, including its medicines agency, ANVISA. The proposed legislation would make ANVISA, a rulemaking institution that previously answered only to the executive branch, into a non-rulemaking body tasked with implementing rules drafted by an outside council whose members would have to be approved by the legislative branch.
The proposed change was met with an immediate uproar from Brazilian industry groups and even its union of pharmaceutical workers, with more than 30 entities signing a manifesto to express opposition to the move and support for ANVISA, which “maintains, still, mutual cooperation agreements with the main world regulatory agencies in the health area,” including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the letter writers argued. “This recognition strengthens national sovereignty and facilitates the insertion of our products in the world market.”
PharmaCielo Receives First Commercial Purchase Order from Ease Labs Pharma (Yahoo Finance)
Ease Labs Pharma, a global pharmaceutical company headquartered in Brazil, has received regulatory approval from the Brazilian Health Regulatory Agency (ANVISA) to launch its Canabidiol Ease Labs 100 mg/ml in Brazil beginning in January 2023, and PharmaCielo’s proprietary API was included as part of that approval.
PharmaCielo has been shipping product to Ease Labs since 2021 in support of its product development efforts. The Company has also made pre-commercial shipments of CBD full spectrum oil containing THC to Ease Labs beginning in June 2022, to support additional product development efforts.
Patient advocacy groups launch fight against Trikafta patents in four countries – including Brazil (Endpoints)
Patient advocacy groups have launched a global effort to increase access to Trikafta, and the groups announced that they have petitioned four governments (including Brazil) to allow generic versions of the drug.
Trikafta was approved in 2019 to address an underling cause of cystic fibrosis. It is specifically approved for patients who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which covers about 90 percent of the cystic fibrosis population. The triplet therapy works by targeting the CFTR gene and is designed to correct the malfunctioning protein it makes.
Biolab expands international presence, targets US market (Valor International)
Biolab, one of Brazil’s leading pharmaceutical companies, is expanding its exposure to foreign markets at the same time as it continues to invest in a new and modern industrial complex in Minas Gerais, an investment estimated at almost BRL $1 billion.
In January, six months after the acquisition of the Canadian laboratory Exzell Pharma, owner of brands such as Swiss Naturals and Salinex, it obtained the registration in Saudi Arabia of Vonau Flash (Ondansetron), an innovative medicine against nausea and vomiting with almost immediate oral dissolution. The company has already exported Vonau to Ecuador and Colombia and supplied another product, Encrise, used to treat septic shock, to Saudi Arabia.
Eurofarma partners with Lotus and Adalvo to bring treatment of multiple myeloma to Brazil (Company website)
Brazil-based Eurofarma announces the arrival of a new drug in its portfolio. Nuvyor is used in the treatment of multiple myeloma – a disease that affects plasma cells, bone marrow cells responsible for the production of antibodies that fight infections. The drug, which is developed and manufactured by Lotus Pharmaceutical Co, Ltd (“Lotus”), out-licensed by Adalvo and approved in June 2022 by Anvisa, arrived in hospitals and clinics in October.
The arrival of Nuvyor (lenalidomide) also marks the strengthening of Eurofarma in the oncologic hematology market, which already had the drugs Fiprima (Brazil’s first biosimilar), Doxorubicin and Imatinib Mesilate. To bring the product to Brazil, Eurofarma partnered with Lotus, the largest oral oncology generic company in Taiwan, and Adalvo, one of the top out-licensing companies considering the relevance of lenalidomide and its forecast in the main treatment protocols of the disease. The company’s projection with the arrival of the new product is to almost double the current revenue of the Oncology Unit.
Hypera Pharma launches contraceptive with isolated drospirenone (Guia de Farmacia)
Mantecorp Farmasa proposes an innovative contraceptive option, drospirenone 4mg alone. Indicated for all women of the most diverse ages, who cannot or do not want to use estrogens due to the risks, the active principle is free of estrogens, that is, the woman has less hormonal exposure, in addition to a low metabolic risk of thrombosis and cardiovascular2. The pill still has a positive effect on the skin, hair and does not encourage weight gain.
“Drospirenone is the evolution of the contraceptive and arrived to modernize the market as an effective and safe option. It offers a longer period of action, greater than 24 hours, and better control of the cycle and bleeding profile₄, with a lower risk in case of forgetfulness”, explains dr. Odair Albano, gynecologist, obstetrician and health consultant.