News
Workshop 03 – 04 February 2011
1st ANNUAL EUCRAF WORKSHOP
Next generation and biosimilar monoclonal antibodies – essential considerations towards regulatory acceptance in Europe
Date: 03 - 04 February 2011
Location: Freiburg i. Breisgau
This workshop has been initiated to provide a platform where regulators, scientists, regulatory affairs professionals, manufacturers and service providers meet, exchange knowledge and views related to the development of monoclonal antibodies, regardless whether they are newly developed, next generation (or follow-up) or biosimilars.
Innovation is introduced by manifold options i.e. through development of new monoclonal antibodies for new indications, by reducing the dose frequency for authorized products or by introducing a new route of administration allowing self-administration.
On the other hand, development of biosimilar monoclonal antibodies has the potential in reducing the health care costs.
Extensive experience has been accumulated in the manufacture and testing approaches utilized in the development of monoclonal antibodies.
The processes to establish productive clones, to manufacture at higher yields, to humanize antibodies on one hand and the test methods to characterize these molecules on the other hand have been evolved tremendously. The available instrumentation more and more provides confidence that the products may be well characterized. However, despite all of these achievements a monoclonal antibody remains a complex construct which is not fully understood as to how specificity, function and structure relate to their clinical mode of action, efficacy and safety.
Other than in the treatment with erythropoietin, growth hormones or G-CSF, monoclonal antibodies are not used to replace or substitute proteins which are naturally occurring but lacking in the individual patient. Monoclonal antibodies instead introduce new pharmacological principles in large indications requiring investigation in conventional large pivotal trials. Each individual antibody is considered an individual molecule for which proof of efficacy and safety is required in this indication based on pivotal endpoints and for the dose claimed.
Consequently, critical questions regularly arising include:
Acceleration of development of monoclonal antibodies is in the interest of all involved stakeholders. However, care needs to be taken to ensure that acceleration does not lead to overlooking potential risks.
This workshop was chaired by Prof. Johannes Löwer and and aimed at the exchange on the common understanding of scientific and regulatory requirements as a prerequisite of successful antibody development.
PROGRAMME OF THE WORKSHOP
Day 1. Thursday, 03. February2011
Session 1: Monoclonal antibodies as attractive targets for development
10.30-10.45 Prof. Dr. Johannes Löwer: Welcome and introduction
10.45-11.30 Michael Reth, Max-Planck-Institut for Immunology, Freiburg, and Gabriele Schäffner-Dallmann, EUCRAF: Monoclonal antibodies in Europe - a historic review and future prospects
11.30-12:30 Christian Schneider, PEI: What is special with monoclonal antibodies?
12:30-13:00 Q&A
13:00-14:30 Lunch
Session 2: Experience in the regulatory process of biosimilars
14:30-15:15 Ann Johnsson, MPA: Experience on already authorized biosimilars – approaches taken to justify the biosimilarity
15:15-16:00 Thomas Kirchlechner, Sandoz Biopharmaceuticals Development: Pioneering the development of biosimilars - lessons learnt and future challenges
16:00-16:30 Coffee break
Session 3: update on upcoming biosimilar guidelines
16:30-17:15 Christian Schneider, PEI: Status update on the guideline on biosimilar monoclonal antibodies
17:15-18:00 Martina Weise, BfArM: Update on WHO guideline
18:00-19:00 Panel discussion with Ann Johnsson, Thomas Kirchlechner, John Purves, Janice Reichert, Christian Schneider, Thomas Schreitmüller and Martina Weise
19:30 Networking Dinner
Day 2. Friday, 04. February2011
Session 4: Key elements in development of a monoclonal antibody
09:00-09:45 Kowid Ho, AFSSAPS: Which attempts will be acceptable for a biosimilar monoclonal antibody - identical copy or altered manufacturing process?
09:45-10:30 Martin van der Plas, RIVM, The Netherlands:
CMC: what can be characterized well, where are the limitations and what is especial for introduction of changes in next generation vs biosimilar monoclonal antibodies
10:30-11:15 Karen de Smet, FAMHP Belgium:
Preclinical development: what are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies
11:15-12:00 Panel discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas
12.00-13.30 Lunch
Session 5: Clinical development
13:30-14:15 Frank Scappaticci Roche/Genentech Inc.: What are the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies
14:15-15:00 Jan Müller-Berghaus, PEI: Key clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation
15:00-15:20 Coffee break
15:20-16:00 Round table discussion with Karen de Smet, Kowid Ho, Jan Müller-Berghaus, John Purves, Janice Reichert, Frank Scappaticci, Thomas Schreitmüller and Martin van der Plas
16:00 Gabriele Schäffner-Dallmann: Wrap up and concluding remark
16:30 End of the workshop
SPEAKERS OF THE WORKSHOP
The workshop provided insight into why monoclonal antibodies were attractive targets for development and what the key elements in development of a monoclonal antibody were. All speakers of the workshop are experts in the field and were involved in the development of monoclonal antibodies or biosimilar products or in the assessment of related regulatory submissions.
Gabriele Schäffner-Dallmann, EUCRAF/Pharmatching GmbH and Michael Reth, Max-Planck-Institut for Immunology Freiburg, provided a historic review and future prospects of monoclonal antibodies in Europe. Christian Schneider, PEI, Germany, discussed what was special with monoclonal antibodies. Ann Johnsson, MPA, Sweden, reviewed the experience on already authorized biosimilars and the approaches taken to justify biosimilarity. Thomas Kirchlechner, Sandoz, reflected the experience and challenges in development of biosimilars. Christian Schneider gave an update on the status of the guideline on biosimilar monoclonal antibodies and Martina Weise, BfArM, Germany, gave an update on the relevant WHO guideline.
Kowid Ho, AFSSAPS, France, presented the attempts being considered acceptable for a biosimilar monoclonal antibody, whether it had to be an identical copy or whether an altered manufacturing process might be acceptable. Martin van der Plas, RIVM, The Netherlands, discussed the CMC requirements and what could be characterized well, where were the limitations and what was special for introduction of changes in next generation vs biosimilar monoclonal antibodies. Karen de Smet, FAMHP, Belgium, gave an introduction into the requirements of preclinical development, what were the challenges in development of a new monoclonal antibody and what need to be considered for next generation and biosimilar monoclonal antibodies.
Frank Scappaticci, Roche/Genentech Inc., UK discussed the challenges in the development of a new monoclonal antibody and what needed to be considered for next generation and biosimilar monoclonal antibodies. For the clinical development, Jan Müller-Berghaus, PEI , Germany, discussed the key elements of clinical evidence – Key points to consider with regard to Surrogate endpoints - Immunogenicity – Extrapolation.
Participants could get a further insight into the current state of the art considerations during the panel discussions with representatives of agencies and industry and a networking dinner offers excellent opportunities to further exchange your views on the matter.