1. Guidelines for assuring the quality of pharmaceutical and biological products prepared by recombinant DNA technology,1991
2. Requirements for human interferons made by recombinant DNA techniques, WHO TRS 771, Annex 7, adopted in 1987, http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_771_(part2http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_771_(part2)_A7.pdf [accessed 01.09.11].
3. Requirements for human interferons prepared from lymphoblastoid cells, WHO TRS 786, Annex 3, adopted in 1988, http://webitpreview.who.int/entity/biologicals/biotechnology/WHO_TRS_786_A3.pdf [accessed 01.09.11].
4. Guidelines for assuring the quality of monoclonal antibodies for use in humans, WHO TRS 822, Annex 3, adopted in 1991, http://whqlibdoc.who.int/trs/WHO_TRS_822.pdf [accessed 01.09.11].
5. Negotiating the emerging biosimilars landscape. key developments in the regulatory environment;Taylor;Business Insights,2008