Agenda

26th - 28th September 2016

The regulatory pathways for the approval of biosimilars are well developed and tested globally. Many countries throughout the world have established legal and regulatory pathways which allow development of biosimilar products. The EU is the first region in the world to have set a legal framework and a regulatory pathway for biosimilars. To date, EMA has approved 22 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, follicular hormones, insulins and monoclonal antibodies for use in the EU. The legislative route creating biosimilars for the US market was created by the enacted healthcare reform law, the Patient Protection and Affordable Care Act (PPAC Act), signed into law in March 2010. The new law also included a pathway for an interchangeable biosimilar, which is a biological drug that can be automatically dispensed without specific prescriber authorization. To date FDA has approved two biosimilars, Zarxio (filgrastim-sndz), 6th March 2015 and Celltrion Inflectra (infliximab-dyyb), 6th April 2016. The challenge is successful uptake in the market.

 

This webinar will provide participants a high level understanding of the factors that influence uptake of biosimilars:

• Clinical package
• Extrapolation
• Naming
• Interchangeability
• The Patent Dance
• The Price
• Education

Led by Rodeina Challand, Biosimilars Consultant, Formerly Director, PRA International

Rodeina Challand, Biosimilars Consultant, Formerly Director, PRA International
• Potential role in therapeutic strategy
• Necessary capabilities and key factors for product development
• Future landscape of the business

Hideaki Nomura, President & CEO, FUJIFILM KYOWA KIRIN BIOLOGICS (FKB), Japan

• Canadian Market
• Regulatory – Differences between Canada and abroad
• Pricing – The top, the bottom and everything in between
• Reimbursement – How the process works and results to date
• Biosimilars track record
• How brand names are responding

George Wyatt, Managing Director, Pharmaceutical Reimbursement Consultant, Wyatt Health Management

• Government funded National Research Infrastructure for the delivery of clinical trials
• Research delivery arm of the NHS
• Facilitated the recruitment over 34,000 patients into commercial clinical trial in 2015/16
• Biosimilars are of importance to the NHS
• Specific response to support biosimilar development

Dr Matt Cooper, Business Development & Marketing Director, NIHR Clinical Research Network Coordinating Centre

• Extrapolation: Considerations for applying a narrow clinical trial experience to a wider set of patients
• Interchangeability: Considerations for a single switch vs. multiple switches
• Labeling: Balancing transparency with clinical relevance. Should we carbon copy from the original or modify?
• Post-Approval Identification: Names, numbers, and the pursuit of nil misattributions

Thomas Felix, MD, Medical Director, R&D Policy, Global Regulatory Affairs and Safety, AMGEN, Inc.

• Critical first step involves extensive interrogation of multiple originator batches to define the target and rank quality attributes.
• Subsequent side-by-side comparison of the biosimilar with the originator to determine biosimilarity.
• Strategies for protein primary and higher order structure determination including measurement of post-translational modifications such as glycosylation and other Critical Quality Attributes.
• Orthogonal analytical techniques for “fingerprint-like” assessment and linking to functional assays.

Dr. Fiona Greer, Global Director, Biopharma Services Development, Life Sciences, SGS

• Quality Strategy
• Typical analytical modules for a biosimilar development
• Potential influences during manufacturing
• Modern analytical techniques to demonstrate biosimilarity

Ulrike Konrad, Business Development Manager, Protagen Protein Services GmbH

• Successful development of biosimilars is dependent upon the establishment of validated and standardized assays that allow direct comparisons of the relative potency of innovator molecules and biosimilars
• A validated standardized cell-based assay high throughput platform has been developed that is applicable to most biopharmaceuticals
• Direct comparison of drug potency of innovator molecules and biosimilars in a single assay.
• Case studies for Beracizumab, Beracizumab and Etanercept will be presented.

Michael Tovey, Director of Research, INSERM, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan

• Dyadic has a commercially proven 30+ year track record as a high quality and highly productive producer of enzymes and proteins using a proprietary and patented expression system based on the Myceliopthora thermophila fungus, nicknamed C1.

• Dyadic is using the knowledge gained over 20 + years from its successful industrial biotechnology business, which it sold to DuPont for $ 75 million on December 31, 2015, to transition its industrially proven C1 technology platform to the BioPharma and LifeScience community to tackle some of the obstacles in biologic drug development and manufacturing costs.

• The C1 platform technology is a hyper-productive fungal expression system used to develop & manufacture large quantities of desired proteins at industrial scale at significantly lower CapEx and OpEx costs.

• So far Dyadic has shown that by using its C1 expression system they can produce Vaccines at high level and with excellent immune response - Dyadic has also displayed the ability to easily express mAb’s.

• Dyadic’s C1 technology has the potential to change the way in which both animal health and human biotech and pharmaceutical companies bring their biologic vaccines and drugs to market faster, in greater volumes, at lower cost, and with newer beneficial properties, and most importantly save lives.

• Dyadic believes that our current efforts, with or without potential partners, to successfully express several therapeutic proteins, will validate the C1 technology as one of the vital production platforms for developing & manufacturing biologic Vaccines and BioPharmaceuticals.

Ronen Tchelet, VP Research & Business Development, Dyadic International Inc.

• Risk-based approaches to biosimilar development
• Strategies in maintaining high quality standard
• Recent development shaping the guidelines for advancing product development and its implications

Prof. Andrea Laslop, Head of Scientific Office. AGES-Austrian Agency for Health and Food Safety

• Similarity of glycosylation profile is critical for biosimilar mAbs
• Similar glycosylation profile can be achieved through screening of clonal cell lines, upstream process development and by using cell engineering approaches
• Combination of these approaches is needed to achieve high degree of similarity while preserving high protein yields

Roman Ivanov, Vice President, Research & Development, CJSC BIOCAD

• Development of complex biosimilars
• Science of extrapolation
• Switching and interchangeability
• Future prospects for biosimilar market

Alex Kudrin, Independent Biopharmaceutical Consultant, formerly VP, Head of Global Development, Celltrion

Ming Wang, CEO, Phanes Therapeutics, formerly VP, Diabetes Disease Area Leader, JANSSEN
• Updates on the latest global regulatory guidelines
• In what capacity should EMA act on switching and interchangeability?
• Current challenges to make sure the development pathways are ready for the latest scientific development
• The current status of biosimilars products in the US, Europe and rest of the World
• Effect of the FDA draft guideline on Non-Propriety Naming of biological and biosimilar products
• Labelling Guidelines for biosimilars

Cecil Nick, Vice President, PAREXEL

• Major regulatory activities in Mexico.
• Requirements for development of clinical studies
• Opportunities for government sales.

Dr. Alfonso López, Medical Director and Biotech, Alvartis Pharma

• Factors to be included in clinical trial development for Biosimilars: present and future
This would deal with: “What are the questions that would need to be answered for a Biosimilar, e.g. present is: bioequivalence, smart endpoints most sensitive indication Ph III, etc / future is: … ”
• Clinical operational challenges: present and future
This would deal with: “How are the questions identified above answered on an operational level – minimize costs / maximize results”

Dr. Ekkehard Brockstedt, Clinical Operations, Boehringer Ingelheim Pharma GmbH & Co. KG

• The History – Phase 1 biosimilars. Market share, pricing, biosimilar impact
• The Present – Phase 2 biosimilars. Market share, pricing, biosimilar impact
• The Future - Barriers to NHS adoption. Understanding, naming, terminology, commissioning

James Kent, PrescQIPP – Secondary Care Lead, Director of Pharmacy, Southend Hospital

• Regulatory Pathway
• Historical data
• Effect size
• Sample size
• Recruitment
• Comparator sourcing and cost

Rodeina Challand B.Sc., Biosimilars Consultant, formerly PRA International

• Incentives – what is needed?
• National tenders
• Attitudes and opinions
• Management, physician and patient cooperation

Dr. Steinar Madsen, Medical Director, Department of Drug Information, NORWEGIAN MEDICINES AGENCY

• Patients have the right to expect that the life of the patient remains the primary guiding principle of biosimilar policy discussion – not potential cost savings;
• USA physicians support labels with data to learn about and evaluate biosimilars;
• European doctors have insufficient knowledge of biosimilars – they’ve got company;
• Canadian physicians feel strongly about the need to retain sole prescription authority;
• USA hospital pharmacists are more likely to be “Very familiar…” with biosimilars than retail pharmacists (but that’s only 44% vs. 23%).

Stephen Murby, Spokesperson on Biosimilars, International Alliance of Patients' Organizations (IAPO)

• Challenges and obstacles faced by manufacturers in developing biosimilars
• How to overcome challenges, increase development success and optimize result
• Techniques in bringing the next generation of Biosimilars to the market
• Reducing capital investment and creating cost effective and scalable manufacturing operations

Dr. Steinar Madsen, Medical Director, Department of Drug Information, NORWEGIAN MEDICINES AGENCY
Dr. Alfonso López, Medical Director and Biotech, Alvartis Pharma
Dr. Fiona M. Greer, Global Director, BioPharma Services Development, SGS LIFE SCIENCES
Ming Wang, CEO, Phanes Therapeutics, formerly VP, Diabetes Disease Area Leader, JANSSEN

Ming Wang, CEO, Phanes Therapeutics, formerly VP, Diabetes Disease Area Leader, JANSSEN