RESUMEN
Biologics are significant drivers of globally escalating healthcare costs. Biosimilars have potential to offer cost savings with comparable efficacy and safety to innovator products and increase the access of treatment to more patients. This study aimed to increase understanding and perception of biosimilars concept. It also described the pharmacoeconomic impact of biosimilar in oncology and formulary consideration of oncology biosimilars substituting with their originators in major oncology centers in the Saudi Arabia. A biosimilar is a biological product that is similar to a reference biopharmaceutical product. As the manufacturing process hinders the ability to identically replicate the structure of the original product, biosimilar cannot be described as an absolute equivalent of the original medication. Different regulatory agencies such as United States Food and Drug Administration, European Medicines Agency, and Saudi Food and Drug Authority have approved several biosimilars of oncology biologics. The experience of biosimilar use in Europe and USA provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving access without compromising patient outcomes. There is a need for increasing awareness about biosimilars to improve acceptance rates. The use of biosimilar filgrastim in Ministry of National Guard Health Affairs, Saudi Arabia, has resulted in a significant cost saving annually. It was proposed that further substitution and switching to biosimilars in oncology would lead to major savings in resources.
RESUMEN
OBJECTIVE: The purpose of this study is to compare the incidence of venous thromboembolism between obese and non-obese hospitalized patients who received United States Food and Drug Administration-approved prophylactic enoxaparin doses and to describe enoxaparin dosing strategies used in obese patients. METHODS: This was a retrospective cohort study including patients who were admitted to Parkview Regional Medical Center, Parkview Hospital, or Parkview Orthopedic Hospital between September 2011 and August 2012 and received at least one dose of enoxaparin 30 mg twice daily or enoxaparin 40 mg once daily for venous thromboembolism prophylaxis. Patients classified based on their body mass index into three groups, Group 1 (non-obese: body mass index < 25 kg/m2), Group 2 (overweight: body mass index ≥ 25 kg/m2 but < 30 kg/m2), and Group 3 (obese: body mass index ≥ 30 kg/m2). The primary endpoint was venous thromboembolism occurrence within 90 days, considering day 1 of hospitalization as day 1. RESULTS: Of the 428 patients included, 8 cases of venous thromboembolism (1.9%) were identified; 3 in the non-obese group, 2 in the overweight group, and 3 in the obese group, no statistically significant differences were found between the three groups, p = 0.81. When venous thromboembolism incidence was adjusted for age and sex, no statistically significant differences were found between overweight (OR = 0.685; 95% CI 0.115-4.095), obese (OR = 0.797; 95% CI 0.353-1.796), and combined overweight and obese (OR = 0.656; 95% CI 0.154-2.799) groups compared to patients with normal body weight. CONCLUSION: This study did not find a statistically significant difference in venous thromboembolism incidence between obese, overweight, and non-obese hospitalized patients receiving approved enoxaparin prophylaxis doses.
