Biosimilars Day 2 - Wednesday 1st November 2017


What are the key new international developments? Ask the regulators!

Elena Wolff-Holz

Welcome keynote address. Biosimilars in the EU: current experiences and outlook

Anne Cook

CMC Strategy: A critical foundation for biosimilars

  • Revision of Quality guidance for biosimilars (CHMP/BWP/247713/2012)
  • Development considerations before clinical trials
  • Critical quality attributes and mechanism of action
Benedicte Lunddahl

Keynote: Danish pharmacovigilance update for biosimilars

  • Uptake of biosimilars in Denmark
  • DKMA action plan on pharmacovigilance of biologicals
  • Raising awareness among stakeholders
  • Danish safety data on biologicals including biosimilars
Benedicte Lunddahl

Panel Discussion on regulation and IP followed by questions from the audience

  • European Regulators positions on interchangeability and public study results as an introduction to the debate on how best to share and communicate real world evidence and pharmacovigilance data.
  • What are the most appropriate means and platforms which could reduce the gap between regulatory science and medical practice and which could inspire others to follow?

Morning refreshments

Development, Manufacturing & Pharmacovigilance

Market access strategies, opportunities and commercial challenges: Biosimilar marketing

Chair: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals


Originator variability and biosimilarity: Lessons learned from the approval of Erelzi in the US

  • The importance of understanding structure – function relationships in biosimilars
  • What is known about the analytical variability of biopharmaceuticals
  • Appropriate tools for assessing biosimilarity (equivalence testing vs min/max and the Erelzi experience)

How to ensure sustainability of the biosimilars market in 2018 and beyond

  • The importance of ‘gain sharing’ and how this is being promoted to all stakeholder groups
  • Improving support from physicians in the future
  • Preventing confusion on interchangeability between USA and Europe
  • Continually rolling out change: what developers can do to help?

Originator and biosimilar mAbs and Fc-fusion state-of-the art analytical methods

Dr Alain Beck, Senior Director, NBEs Analytical Chemistry, Centre d'Immunologie Pierre Fabre

What are the mechanics required behind the implementation of biosimilars in the market?

  • How important is post-market surveillance to implementing biosimilars in the market in the first place?
  • Overview of the current situation pertaining to the global debate on naming of biosimilars
  • How has USA’s first biosimilar approval contributed to the debate on naming? What can we expect to see with this ongoing debate as we move closer to 2020?
  • What role do collaborations and partnerships, including between academia and industry, play in the development of biosimilars?

Development considerations: Comparing major markets including US, EU, Japan and China

  • Different approaches to similarity of Quality attributes
  • Navigating different clinical data requirements – endpoints
  • Choice of reference product
  • Ethnicity and need for data from local patients
  • Interchangeability
  • Meeting with regulators
  • Conducting global studies

Importance of analytical methods for the success of biosimilars: case studies

  • Examples from the analytical and formulation work performed during the development of        
  • Biosimilars
  • Analytical challenges and the importance of new analytical methods
  • Formulation challenges and the importance of studies of aggregation in human plasma

The Biosimilars fight for uptake

  • EU and National Authorities positions supporting to biosimilars 
  • Key market barriers hindering the development of Biosimilars
  • Recommendations for patient’s access improvement

TBC: Challenges in biosimilar bioanalytical assays and sample processing

  • Hear about techniques for PK assay development and compound comparison for analytical similarity
  • Gain insights into ADA assay development and sample measurement strategies in a special case in a special case
  • Learn about automated sample analysis on biosimilars

Successful biosimilar product case studies from benchtop to market




Future development & manufacturing strategies


IP and legal considerations for biosimilars

Chair: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

Chair: Stacie Ropka, Partner, Axinn, Veltrop & Harkrider LLP


Streamlining clinical development of biosimilars

  • Facilitating success - case study examples of working with the biosimilars industry
  • The successful network approach - a UK strategy to drive delivery of biosimilar clinical trials
  • Forward thinking approach - attitudes, appetite and acceptance in the NHS

Customisation of various analogues of insulin during manufacture

  • Manufacture and downstream output of various insulin analogues
  • Tackling challenges in preventing protein modification during multiple downstream steps
  • Solid characterisation and safety

A year to review: 2017, more decisions, more launches, more unanswered questions

  • Hear how the year has played out from a legal perspective
  • What are we seeing from the US in terms of new decisions, new launches and their analysis of the data being submitted?
  • Incorporating IPRs into biosimilar litigation strategies
  • What impact is that having on the global biosimilar sector?

Future manufacturing plants for biosimilar production

Please contact Derek Cavanagh for more information. e/ t/+44 (0)207 092 1297

Panel: Legal and IP strategies to strengthen biosimilar medicine developers

  • How Brexit will impact the IP landscape and business strategies for the sector
  • A competitiveness boost: what are the opportunities for biosimilar medicine developers?
  • Establishing sustainability for second medical use patents
  • How to take advantage of the IP and regulatory environments to grow the generic and value added medicines business
  • Antitrust case law and latest developments
  • Inconsistencies in the SPC case law

Afternoon refreshments and exhibition viewing

Closing keynotes: post launch strategies for biosimilars

Richard DiCicco

Chairman: Richard DiCicco, Chairman, Harvest Moon Pharmaceuticals

Francois Xavier Frapaise MD

Patients & biosimilars – the most important stakeholder

  • Discover novel approaches to including the patient vision in trial design
  • Understand the role of the patient post-commercialization
  • Learn why Merck Biosimilars works with a patient advisory board to include the patient voice at every stage of biosimilar development)
Ian Henshaw

Biosimilars uptake and market considerations in the EU

  • Biogen’s experiences within the EU, and their joint venture with Samsung Bioepis
  • Biosimilars uptake in the EU –  experience case study
  • Impact of biosimilars for patients, HCPs and payers
Florian Turk

Achieving broad and sustainable access to biologic medicines through biosimilars


Closing remarks from the chair


Close of conference

last published: 19/Sep/17 14:17 GMT