Biosimilars
Biosimilars and treatment of IBD in Italy
In February 2015, the patent for infliximab expired in Italy. Now, biosimilar CT-P13 products (Remsima and Inflectra), the first monoclonal antibody biosimilar of infliximab, are on the Italian market. In their recent paper, Annese et al. [1], assessed gastroenterologist’s view of the use of CT-P13 for the treatment of inflammatory bowel disease (IBD) in Italy.
EC publishes improved biosimilars information for patients
On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients containing reliable information on biosimilar medicines.
Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).
European IBD specialists support switching to biosimilars
The European Crohn’s and Colitis Organization (ECCO) has published results of a consensus meeting held on 15 October 2016 in Vienna, Austria in which they support switching from reference infliximab to biosimilar infliximab [1].
What makes physicians consider patients suitable for biosimilar infliximab
Prescribing physicians play an important role in the adoption of biosimilars in rheumatic diseases. Assessing physician perception of patients they consider as suitable for biosimilars may provide insights into eventual biosimilar adoption in clinical practice settings as well as any physician educational needs.
European oncologists back biosimilars with position paper
On 16 January 2017, the European Society for Medical Oncology (ESMO) published a position paper on biosimilars saying that ‘biosimilars create opportunities for sustainable cancer care’ [1].
EMA approval for rituximab biosimilar Truxima
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 that it had recommended granting of marketing authorization for a rituximab biosimilar.
What internists should know about biologicals and biosimilars
Authors from the IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy discuss some of the most frequent concerns raised by internists about biosimilars [1].
Benepali gains approval for extra indications
Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali
Biosimilars applications under review by EMA – December 2016
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
