Biological product development for launch in multiple geographies with varied regulatory
expectations would require a planned and focused strategy, involving the selection of the …

Challenges in demonstrating interchangeability and safety, as well as the ongoing evolution
of regulations governing biosimilars, have meant that the development of the biosimilars …

The coming wave of patent expiries of first generation commercialized biotherapeutical
drugs has seen the global market open its doors to close copies of these products. These …

Abstract The World Health Assembly in 2014 adopted a resolution that mandates both
Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a …

Biopharmaceuticals based on recombinant proteins have started to go off-patent, opening
the way for other manufacturers to place follow-on products to the market. Meanwhile it has …

Biosimilars are the biological drugs that are granted after the expiry of the patent of an
affirmed innovator. Asia Pacific countries are characterized by significant demand as they …

Biologics have revolutionised the treatment of many severe conditions, delivering
exceptional clinical results but also producing exceptionally high prices. As patents expire …

Biologic medicinal products developed via rDNA technology as recombinant protein-based
medicines that have been in clinical use since the early 1980s as original …

The objective of this chapter is to understand the scientific challenges and the main
elements of the EU pathway and the proposed US FDA regulatory pathway for biosimilars …

Highlights•We examine strategies for success in the global biosimilar market.•New entrants
and originators should strengthen medical affairs functions.•Only blockbuster biosimilars …