Regulatory issues for licensing similar biological medicine in different EU countries and in Republic of Macedonia
- At: 2013 FIP Congress in Dublin (Ireland)
- Type: Poster
- By: GROZDANOVA, Aleksandra (Faculty of Pharmacy, Pharmaceutical chemistry, Skopje, Macedonia)
- Co-author(s): Anchevska Netkovska, Katerina (Faculty of Pharmacy, Skopje, Macedonia)
Suturkova, Ljubica (Faculty of Pharmacy, Skopje, Macedonia)
Nasteva, Natasha (Alkaloid AD, Skopje, Macedonia)
Approval of biosimilars is based on abbreviated registration process, which allows manufacturers to provide a reduced package of information, and prove similarity to the reference drug. Since patents of several biological medicines have already expired in the Europe, biosimilars of these products are currently approved by the EMA. Although many.. The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.