Pre-Conference Workshop (X): Tuesday 20 May 2014
Update and Best Strategies for Accessing the US Market for Biosimilars
Registration is at 08:30 for a 09:00 start. The workshop will finish no later than 16:00. Workshop documents, refreshments and lunch will be provided.
Update on progress of US biosimilar guidelines and beyond
- What is the current status of FDA biosimilar guidelines and likely timelines for finalisation?
- Using the FDA biosimilar guidelines as a competitive tool
- Commercial barriers beyond FDA biosimilar guidelines
- INN naming: An alternative way of looking at this hot topic
- How will approaches to biosimilars vary between different US states vs. federal agency FDA and what is the impact on the fate of biosimilars?
- To what degree will FDA follow suit of the EMA regarding approval of biosimilars? Compare US and Europe, how are they aligning?
- Coordination between authorities - joint EMA-FDA informal scientific advice: How is it working?
- I have a dream: One application for several authorities; is it possible in 2014?
- Best strategies to avoid the 351k pathway and still be reimbursed by payers with physician and patients’ acceptance
Michel Mikhail, Chief Regulatory Officer, Executive Vice President, Global Regulatory – Governmental Relations, Fresenius Kabi, Germany
Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals, USA
Evening Seminar (S): Wednesday 21 May 2014
Regulatory Professionals Evening Surgery
Registration is at 18:00 for an 18:15 start. The seminar will finish no later than 20:30. Seminar documents and an evening networking dinner will be provided.
This highly interactive seminar will provide regulatory feedback on key regulatory hurdles encountered by industry. This will be followed with time for open Q&A so that specific individual issues can be discussed.
- How similar is similar? What is likely not to be accepted by the regulator?
- Comparability studies: Regulatory guidance on how to practically carry out comparability studies and prove comparability to the regulator?
- Immunogenicity: How should immunogenicity be reported? How can key concerns and risk be measured and effectively addressed?
- Extrapolation of indications: How do regulators justify doing extrapolation?
- How do the regulators handle biosimilar applications from industry and what is the experience here?
- What is the regulatory advice on a stepwise approach for achieving approval, including the analytical package and clinical testing?
The above topics will form the main focus of the seminar, however there will be opportunity to discuss other issues and ask specific questions.
Dr Gabriele Reichmann, Scientific Assessor, Paul-Ehrlich-Institute, Germany
Roman Ivanov, Vice President, Research & Development, BIOCAD, Russia
Daotian Fu, Executive VP, Livzon Mabpharm, Inc., China
Post-Conference Workshop (Z): Friday 23 May 2014
Practically Conducting Clinical Development of Biosimilars and Complying with Regulatory Expectations
Registration is at 08.30 for a 09.00 start. The workshop will finish no later than 16.00. Workshop documents, refreshments and lunch will be provided.
- Clinical development of Biosimilars versus Generics and novel Biopharmaceuticals
- Designing single global clinical trials for US and EU
- Practical considerations of originator sourcing
- Practical considerations for designing biosimilars clinical studies, including:
- Study size – is there scope to reduce the size of clinical trial?
- How much data is required?
- What is the best way to present data to the regulators?
- How do you carry out effective comparative analysis of clinical data and ensure this comparison is fair?
- Can clinical trials be used to prove interchangeability and how can this be carried out?
- Are pharmacodynamics studies ever acceptable to show biosimilarity when indications are not approved?
- How can clinical study costs be effectively controlled and kept to a minimum?
- Determination of the relative immunogenicity of innovator products and biosimilars during clinical development.
Workshop leaders :
Carsten Brockmeyer, CEO, Formycon, AG, Germany
Michael G Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, ENS-Cachan, France
Philippe Stas, Chief Executive Officer, BLA Consult bvba, Belgium