Shelley Gandhi Chairs the 2nd Annual Biosimilars Europe Congress

Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, has been invited to Chair the 2nd Annual Biosimilars Europe Congress Nov 23 – 24, 2017 at Hilton London Olympia, London.

The conference will bring together industry experts to explore the strategies to gain insight into new biosimilar development strategies, different characterization and analysis methods, clinical advancement and successful case studies.

This conference offers a rare opportunity to its participants to understand and learn from top experts in the biosimilars field and to share experiences. The conference will also provide a platform to discuss the current vital issues, regulatory issues, market assessment and commercialization and globalization.

Key themes:

  • Current status of Biosimliars market
  • Monoclonal antibody Biosimilars
  • Challenges faced when moving towards globalization
  • Opportunities in emerging markets
  • IP issues, naming and labelling issues related to biosimilars
  • Partnership, new investment and business models
  • Challenges and opportunities for biobetters and monoclonal antibody biosimilars
  • Clinical trials strategies and new guidelines for biosimilar clinical trials
  • Benefits and concerns of interchangeable and biosubstitutes and post authorization monitoring
  • Bringing biosimilars closer to patients and healthcare professionals
  • New solutions to demonstrate similarity and different characterization methods

To find out more about the event click here.

 

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Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group

Interchangeability. An insurmountable fifth hurdle?

NDA Advisory Board member, Paul Chamberlain, has just had an article, written in collaboration with Dr Hans Ebbers (University of Utrecht, The Netherlands) published in Generics and Biosimilars Initiative Journal (GaBI Journal):

“Interchangeability. An insurmountable fifth hurdle?”

This article questions whether designation of biosimilar products as “interchangeable” is a feasible objective in the sense where this would allow automatic substitution at the pharmacy level. Arguably, the burden of demonstrating continuing biosimilarity in the post-approval setting could outweigh the potential cost benefits to the public healthcare system.

 

 

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Paul Chamberlain, NDA Group Biopharmaceuticals Expert and NDA Advisory Board member

Making Progress with Biosimilars

NDA Group’s Dr Gopalan Narayanan has published an article in EBR magazine addressing the market for biosimilars as a lower-cost alternative. Biosimilars were originally eyed with suspicion by several stakeholders when introduced in the EU in 2004. Since then, there has been increasing global recognition of their value, with the first monoclonal antibody being approved in 2013 in the EU.

Dr Gopalan Narayanan has over 15 years’ combined experience within the biologics and biotech industry at the MHRA as Head of Biologicals Unit and as an Expert Medical Assessor, and at Chiron as an Associate Medical Director. Gopalan is qualified as a doctor and is a post-graduate in General Internal Medicine and Pharmaceutical Medicine.

 

 

 

Gopalan Narayanan

 

 

 

 

 

Gopalan Narayanan, Biologics and Advanced Therapies expert NDA Group

Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway

NDA Advisory Board member, Paul Chamberlain, has just had an article published in Biosimilars magazine. The article is titled:

“Multidisciplinary approach to evaluating immunogenicity of biosimilars: lessons learnt and open questions based on 10 years’ experience of the European Union regulatory pathway’.

The article comprehensively reviews the weight of evidence for EU approval of biosimilar products, including clinical, non-clinical, product quality and bioanalytical aspects. Unresolved questions concerning the limitations of post-marketing data to assure continuing biosimilarity, potential immunogenicity-related risks associated with switching medications, interchangeability and substitution are also discussed.

Read the full article here

 

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Paul Chamberlain, NDA Group Biopharmaceuticals Expert and NDA Advisory Board member

Prof. Steffen Thirstrup co-chairs biosimilars at EU DIA Biosimilars Workshop November 21-22 in Dublin, Ireland

Medical Advisor and NDA Advisory Board Member, Steffen Thirstrup (MD, PhD) is taking part in a DIA event titled “Biosimilars workshop – European experiences and challenges” in Dublin on 21-22 November. Steffen Thirstrup has been the chair of the organizing committee of this workshop.

This 1.5 day workshop will focus on the European experience with biosimilar medicinal products, giving an overview of the current regulatory and market-access situation, lessons learned, together with the challenges faced by two classes of products, Erythropoietin (EPO) and Granulocyte-Colony Stimulation Factor (G-CSF).

For more information, please click here

Prof. Steffen Thirstrup speaks at DIA Biosimilars 2013 November 13-14 in Bethesda, Maryland, USA

Medical Advisor and NDA Advisory Board Member, Steffen Thirstrup (MD, PhD) is attending and speaking at the DIA Biosimilars Conference on 13-14 November in Bethesda, Maryland, USA. Steffen will run a session on ‘Market experience in EU’, which will address the EU’s approach to biosimilars and his experience of how this works in practice. Steffen was co-chair for the project group on Market Access for Biosimilars under EC’s Platform on Access to Medicines in Europe. To find out more, please click here.

Biosimilars in the EU – what have we learned so far?

NDA Group Advisory Board member, Steffen Thirstrup, has written an article in Scrip Regulatory Affairs Magazine Sep 2013 on ‘Biosimilars in the EU – what have we learned so far?’

With the EU set to approve its first two biosimilar monoclonal antibodies, Steffen looks back over the past seven years since the first biosimilars were approved and examines the lessons learnt and the outlook in the EU.

 

Biosimilars by Steffen Thirstrup

This article was published in Scrip Regulatory Affairs September 2013

 

Dr Steffen Thirstrup

Dr Steffen Thirstrup, MD, PhD
Medical Advisor, NDA Group

Previously Head of Division, Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority. During his 9 years with the regulatory agency in Denmark, Steffen held several significant roles including 5 years as CHMP member, 1 year as a member of the Committee for Advanced Therapies (CAT), Chairman of the CHMP Respiratory Drafting Group and Co-Chair of the EC Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in EU. Steffen is a medical doctor, has a PhD in pharmacology and has a broad clinical background in general internal medicine with a special interest in respiratory medicine combined with an in-depth knowledge of clinical pharmacology and therapeutics.

He is Board Certified Specialist in Clinical Pharmacology and Therapeutics with the National Board of Health in Denmark. He is also adjunct professor at the School of Pharmacy, Faculty of Health Sciences at the University of Copenhagen.