Biological therapies have revolutionized the treatment of several cancers and systemic
immune-mediated inflammatory conditions. Expiry of patents protecting a number of …

The approval pathway for biosimilars of monoclonal antibodies in the European Union is
aimed at ruling out the presence of significant differences with the original biological in …

The approval pathway for biosimilars of monoclonal antibodies in the European Union is
aimed at ruling out the presence of significant differences with the original biological in …

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 …

The biosimilars market, many analysts believe, is on the cusp of significant growth. This
growth in large part is due to the fact that numerous monoclonal antibody (mAh) biosimilars …

What is known and Objective Biopharmaceuticals are an important class of drugs for the
treatment of autoimmune/inflammatory and oncologic diseases. With patent expiries …

Background Despite regulatory efforts to formalize guidance policies on biosimilars, there
remains a need to educate healthcare stakeholders on the acknowledged definition of …

Biosimilar agents are approximate copies of branded biologic therapies. Since the first
biosimilar was authorized in the European Union in 2006, fifteen additional agents have …

Background: Biosimilars have the potential to create competition, lower costs, and increase
patient access to biological medications. However, biological medications are sensitive to …

Biosimilars represent a novel category in the world of follow-up medicinal products with the
requirement that they are highly similar but not identical to an approved originator biologic …