Review Article

Current trends for biosimilars in the Latin American market

Author(s): , , , , , , , ,

Abstract: The number of approved biological medicines in the global pharmaceutical market has been increasing over recent decades. However, their high costs have motivated the manufacture of biosimilar products, following… Read More »

Global Challenges in the Manufacture, Regulation and International Harmonisation of GMP and Quality Standards for Biopharmaceuticals

Author(s): , ,

Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. With the patent expiry of… Read More »

Tailored development program of Pelmeg®, a biosimilar pegfilgrastim

Author(s): , , , ,

Abstract: Pelmeg® is a biosimilar pegfilgrastim, which has obtained regulatory approval in the European Union (EU) in 2018. A comprehensive analytical, functional, and preclinical comparability program demonstrated a high degree… Read More »

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