Although patents on several key biopharmaceuticals expired some years ago, biogenerics have not yet reached the market in the Triad (Japan, North America and Western Europe)1— a situation contrasting with other markets such as China, South-East Asia and Latin America, where biogenerics are a reality. This paper provides a broad overview of the ongoing developments in the biogenerics scene and discusses the issues and hurdles faced by prospective biogenerics developers in the Triad.
Although, in this paper, only the situations in Western Europe and North America are discussed.
2.
CPMP/BWP 3207/00, ‘Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance’, released for consultation June 2000.
3.
CPMP 3097/02, ‘Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substances’, released for consultation July 2002.
