We’re pleased to announce that BioVirtus is attending and exhibiting at the Biosimilars Global Congress Europe which is taking place in London, September 17-19, 2014.

We hope you will take the opportunity to visit our booth and discuss potential cooperation in early drug development with our representatives.

The event organized by Paradigm Global Events provides an interactive discussion and networking platform led by key biosimilars experts with intimate knowledge in the industry.

Summary after the event…

After recent approval of the first monoclonal antibody biosimilar to Remicade® (Infliximab) in the EU under the names of Remsima® (Celtrion), and Inflectra® (Hospira), the meeting focused on future directions for biosimilar monoclonal antibodies, particularly regulatory aspects, indications extrapolations, possible substitutions, and harmonization of regulations worldwide. If featured excellent presentations on several relevant topics, including pre-clinical comparability by Dr. Marcus Mreyen from Protagen, and reflections on development of Inflectra® by Dr. Nancy Martin from Hospira. All sessions were skillfully chaired by Dr. Richard DiCicco, Co-founder and CEO of Harvest Moon Pharmaceuticals.

Dr. Steinar Madsen from the Norwegian Medicines Agency presented his country’s experience with biosimilar Infliximab (Norway was the first European country to start using it). Dr. Madsen discussed price erosion after introduction of the biosimilar Infliximab for both, the biosimilar, and the originator’s molecules, as well as physicians attitude towards the biosimilar. In order to facilitate the uptake of the biosimilar Infliximab Norway started a switching study with the goal to prove that the originator’s Remicade® can be safely substituted by the biosimilar Infliximab.

Dr. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety, provided perspective on the ongoing revisions of the guidelines for biosimilars, and coordination of efforts in that respect between EMA and FDA. Dr. Patricia Hurley from PPD discussed the upcoming EU clinical trials regulations and their potential impact on biosimilars.

Sizeable part of the meeting was devoted to the so called „emerging markets”, and various regulatory approaches undertaken by individual countries from that market segment. Meeting participants agreed that more uniform regulatory approaches are needed, and made a suggestion, that biosimilars should be regulated by ICH, what would ensure adoption of unified rules by all members of this organization. Such solution would also allow to avoid unnecessary, duplicative clinical trials now required by many countries from outside of the EU.

Dr. Rodeina Challand from PRA Health Sciences discussed proposed naming of Biosimilars, and its potential impact on interchangeability and substitutions. A lively discussion followed her presentation, where participants agreed, that the uniform naming facilitating interchangeability and substitutions may not necessarily be in conflict with traceability.

Presentation of Ms. Renita Rathinam from Sughrue Mion, PLLC, opened discussion on the current legal issues surrounding biosimilars in the US, clearly favoring innovators and opening the doors to litigations of companies developing biosimilars. The EU has a clear lead on implementing more biosimilar-friendly regulations, and the hope is that the US will follow in the next few years.

At BioVirtus we look forward to meeting you at the upcoming conferences on Biosimilars in the EU, and in the US. We also encourage you to contact us with your questions on biosimilars, particularly regarding pre-clinical, and clinical development.

Piotr Lassota, M.D., Ph.D.

Scientific Advisor, BioVirtus Research Site

Photos from the Congress will come soon…