About

We are pleased to announce the MHRA Masterclass on Biosimilars – Successful biosimilars: lessons learned from 12 years of assessment. The masterclass will provide valuable insights for all professionals involved in the development of biosimilar medicinal products (process development scientists, physicians, pharmacokineticists, statisticians, immunologists, regulatory affairs staff).

The event will provide a general update of the current EU regulatory trends in the requirements for biosimilar applications. This will be followed by five specific sessions that will focus on a number of recurrent issues encountered by the regulators during the evaluation of biosimilar applications in the following domains: Quality, Pharmacokinetics, Pharmacodynamics & Efficacy, Immunogenicity and Pharmacovigilance.

CPD

Delegates attending the Biosimilars Masterclass will be eligible to claim CPD points.

Questions for the panel

Once you have registered, you have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. They will endeavour to answer as many of these questions as they can at the event. Please include the session your question relates to when submitting.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu. You will be issued with login details on your registration confirmation email.

Twitter - #MHRABiosimilars

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Agenda

All of the Speakers and Assessors in the masterclass are from the Medicines and Healthcare products Regulatory Agency.

  • Registration & Networking

  • Welcome & Introduction

    Speakers:
    • Julian Bonnerjea, Unit Manager, Biologicals Unit, Licensing Division
  • General session

    Speakers:
    • Anne Cook, Expert Quality Assessor, Biologicals Unit, Licensing Division
    • Marie-Christine Bielsky, Expert Medical Assessor, Biologicals Unit, Licensing Division
    • David Brown, Expert Statistical Assessor, Statistics and Pharmacokinetics Unit, Licensing Division
    • Meenu Wadhwa, Section Leader, Cytokines and Growth Factors Section, Biotherapeutics Group, National Institute for Biological Standards and Control

    What's new?

    • What are the new guidelines?
    • Where are we with statistical principles for quality assessment?
    • Do we need animal studies?
    • Are reference standards available?

     

    General Principles

    • The comparability exercise
    • The stepwise approach
    • The choice of reference product
    • The product information
  • Session on quality aspects

    Speakers:
    • Anne Cook, Expert Quality Assessor, Biologicals Unit, Licensing Division
    • Janet Glassford, Senior Quality Assessor, Biologicals Unit, Licensing Division
    • How to conduct a biosimilar product development: common pitfalls and how to avoid them
    • How to present similarities and differences; should statistical comparative tests be performed?
    • How to deal with shifts in the quality target profile of the reference product

     

  • Refreshments

  • Session on pharmacokinetics

    Speakers:
    • Justin Pittaway-Hay, Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, Licensing Division
    • Essam Kerwash, Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, Licensing Division
    • David Brown, Expert Statistical Assessor, Statistics and Pharmacokinetics Unit, Licensing Division
    • How to choose the optimal design; how to deal with period effect
    • Who are the most appropriate subjects?
    • How to choose the most sensitive dose
    • Is it possible to adjust for protein content?
    • How to present negative studies
    • Can PK modelling be used?

     

  • Session on pharmacodynamics and efficacy

    Speakers:
    • What are the most appropriate endpoints? Are long-term endpoints required?
    • How to justify the equivalence margin? Are non-inferiority trials possible?
    • What to do if patient management has changed?
    • Are switching studies needed?
    • Can studies be conducted in non-EU subjects?
    • How should extrapolation be justified?
  • Lunch break

  • Session on immunogenicity

    Speakers:
    • Andrew Exley, Medical Assessor, Biologicals Unit, Licensing Division
    • Meenu Wadhwa, Section Leader, Cytokines and Growth Factors Section, Biotherapeutics Group, National Institute for Biological Standards and Control
    • Essam Kerwash, Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, Licensing Division
    • What are the expectations from bioanalytical assays?
    • What data are expected in the validation reports?
    • What should be the frequency of tests and duration of follow-up?
    • How to present immunogenicity results
    • How to account for effects of ADAs on PK, efficacy and safety
  • Session on Pharmacovigilance (Risk Management Plan and Periodic Safety Update Reports)

    Speakers:
    • Shahin Kauser, Senior Scientific Assessor, Vigilance Risk Management of Medicines Division
    • Patrick Batty, Expert Scientific Assessor, Vigilance Risk Management of Medicines Division
    • What are the expectations for the safety specification for biosimilars?
    • What is required to ensure traceability of biosimilars?
    • How to produce simple specific ADR follow up questionnaires
    • How to collate information on switching that occur in clinical practice
    • Are there specific requirements for producing PSURs for biosimilars?
  • Refreshments

  • Q & A Session

  • Closes

Meet the Speakers

Anne Cook photo

Anne Cook

Expert Quality Assessor, Biologicals Unit, Licensing Division

Anne Cook is an Expert Quality Assessor at the MHRA, where s...
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Marie-Christine Bielsky photo

Marie-Christine Bielsky

Expert Medical Assessor, Biologicals Unit, Licensing Division

Marie-Christine Bielsky is an Expert Medical Assessor at the...
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David Brown photo

David Brown

Expert Statistical Assessor, Statistics and Pharmacokinetics Unit, Licensing Division

David Brown is an Expert Statistical Assessor at the MHRA wh...
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Meenu Wadhwa photo

Meenu Wadhwa

Section Leader, Cytokines and Growth Factors Section, Biotherapeutics Group, National Institute for Biological Standards and Control

Meenu Wadhwa is Section Leader in the Biotherapeutics Group...
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Janet Glassford photo

Janet Glassford

Senior Quality Assessor, Biologicals Unit, Licensing Division

Janet Glassford is a Senior Quality Assessor at the MHRA. Si...
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Justin Pittaway-Hay photo

Justin Pittaway-Hay

Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, Licensing Division

Justin Pittaway-Hay is a Pharmacokinetics Assessor at the MH...
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Essam Kerwash photo

Essam Kerwash

Pharmacokinetics Assessor, Statistics and Pharmacokinetics Unit, Licensing Division

Essam Kerwash is a Pharmacokinetics Assessor at the MHRA PK...
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Andrea Wallington photo

Andrea Wallington

Senior Medical Assessor, Biologicals Unit, Licensing Division

Andrea Wallington is a Senior Medical Assessor at the MHRA....
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Shahin Kauser photo

Shahin Kauser

Senior Scientific Assessor, Vigilance Risk Management of Medicines Division

Shahin Kauser is a Leading Senior Scientific Assessor in the...
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Patrick Batty photo

Patrick Batty

Expert Scientific Assessor, Vigilance Risk Management of Medicines Division

Patrick Batty is an Expert Scientific Assessor in the Vigila...
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Andrew Exley photo

Andrew Exley

Medical Assessor, Biologicals Unit, Licensing Division

Andrew Exley is a Medical Assessor at the MHRA. Since joinin...
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Venue

MHRA Offices
10 South Colonnade
Canary Wharf
London
E14 4PU

Location

A few minutes walk from the Canary Wharf tube station on the Jubliee line or the DLR.

Register

In order to register for the event, please click the register button below. Please ensure you have all your details ready.

Non-commercial rate* – If you work for a non-commercial industry, please contact us directly to determine if you are eligible for this rate. 

* the non commericial rate is applicable for Charities / Third Sector / NHS / Government & Academic

 

Contact Us

MHRA have appointed Glasgows to organise the event and host the online registration process.

For more information about other MHRA events please visit the conference and education section of the MHRA website: www.mhra.gov.uk.