Biosimilar medicinal products (biosimilars) have become a reality in the European Union
and will soon be available in the United States. Despite an established legal pathway for …

Biologic agents have revolutionized the care management of many life-threatening and
debilitating diseases. As patents for older biologic therapies have begun to expire, the …

Despite the establishment of a specific approval pathway, the issuance of detailed scientific
guidelines for the development of similar biological medicinal products (so-called …

Biological medicines (biologics) are produced in living cells and purified in complex, multi-
step processes. Compared with chemically synthesized small-molecule drugs, biologics are …

Biosimilars are similar, but non-identical, versions of existing biological drugs for which
patents have expired. Despite the rigorous approval process for biosimilars, concerns have …

BACKGROUND: Biosimilars are defined as biologic products that are highly similar to
reference products, notwithstanding minor differences in clinically inactive components, with …

Therapeutic proteins may undergo a series of modifications throughout their production,
processing, and storage. These modifications can include the addition or replacement of …

Purpose To explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in
four large Italian geographic areas, where different health policy interventions to promote …

In the European Union (EU), the regulatory policy for biosimilars has enabled different
biosimilar products to be marketed through an abridged application, which allows the …

Purpose This article aims to analyse the key regulatory guidelines across the globe
concerning biosimilars. Materials and methods Review of the current literature. Results …