biosimilarelor
Biosimilarelor, known in English as biosimilars, are biologic medical products that are highly similar to already approved reference biologic medicines. These products are developed once the patent and exclusivity rights of the original biologic expire and are designed to offer comparable safety, efficacy, and quality.
Biosimilars are not considered generic drugs, primarily because biologics are complex molecules produced through living organisms,
The development of biosimilars aims to increase competition in the biologic market, potentially reducing healthcare costs
Regulatory agencies, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA),
While biosimilars offer promising benefits, concerns regarding immunogenicity, interchangeability, and substitution practices remain topics of ongoing