Current trends for biosimilars in the Latin American market

Abstract

The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.

Oxygenation Status of Malignant Tumors vs. Normal Tissues: Critical Evaluation and Updated Data Source Based on Direct Measurements with pO2 Microsensors

“…As shown in Table 6, tissue oxygen levels in healthy individuals may vary due to (a) zonal structures (e.g., liver), (b) compartmentations within organs and tissues (e.g., eye, bone), (c) age-related changes (e.g., thymus), (d) different morphologies with special functions (e.g., brain, kidney), (e) existence of different tissue subtypes and their individual functions (e.g., white and brown adipose tissue), (f) adjacent tissue layers with specific functions (e.g., epidermis and dermis involved in thermoregulation), (g) organs that have a specific microvascular organization (e.g., closed [8,[92][93][94] vs. open circulation in the spleen), (h) tissues with dual, diffusive and convective, oxygen supply (e.g., skin), (i) hollow organs exposed to varying wall tensions (e.g., heart, aortic wall, urinary bladder), and (j) temporary, rapidly growing organ systems (e.g., fetal-placental unit). Note: It should be pointed out-as mentioned earlier in this article-that the oxygen extraction rate is a major determinant of the actual tissue oxygenation as already described for tumors (see Sect.…”