Biosimilars Regulatory Update: an Evolving Landscape

Date: February 22, 2011
Pages: 59
Price:
US$ 395.00
Publisher: FirstWord
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: B32935DA6DCEN
Leaflet:

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Biosimilars Regulatory Update: an Evolving Landscape
They’re costly to develop, fraught with potential patient safety concerns and subject to regulations that have yet to be written.

Yet for the pharmaceutical industry, biosimilar monoclonal antibodies (mAbs) represent a potential treasure chest of new drugs—and bigger profits.

Yet while the industry is poised to move swiftly in developing new drugs that will plump weak pipelines, regulators have been cautious about instituting guidelines for what is a dynamic and evolving field.

All that is about to change, however, with the European Medicine Agency’s (EMA) recent release of draft guidelines for mAb development that make the prospect of lower cost, robustly-tested biosimilars a real possibility. Now full-fledged pioneers in the area, the EMA’s guidelines are expected to be finalized in May 2011, and may well forge a path for the United States to follow.

Although the Federal Drug Administration (FDA) has uncharacteristically trailed behind in the biosimilar race, it now has them firmly on the agenda. An approach to approving biosimilars through an abbreviated pathway is now being developed following a period of public consultation.

In Biosimilars Regulatory Update: an evolving landscape, FirstWord offers a timely and thorough analysis of Europe’s new biosimilar draft guidelines, cast against the FDA’s consideration of just how biosimilar approval should proceed in the US.

The fascinating report offers clear and critical insights into an otherwise complex topic, at a time when the industry must keep pace more than ever with developments. Containing a full breakdown of clinical and non-clinical requirements for Europe, immunogenicity assessments, a guide to the US position and a section on pharmacovigilance, the report is an accurate state-of-play on a dynamic and shifting environment.

The report offers:
  • A concise and timely overview of European and US developments
  • A comprehensive review of EMA and FDA consultations and guidelines

Key features
  • Analysis of the European regulations and potential moves by the US
  • Complete and concise review of guideline specifics including safety requirements
  • Examination of key issues facing biosimilar developments and how legislation may ease barriers
  • Analysis of immunogenicity assessments
  • Sections on pharmacovigilance and issues surrounding biosimilarity
EXECUTIVE SUMMARY

EUROPE ON THE WAY TO BIOSIMILAR MONOCLONAL ANTIBODIES

Non-clinical and clinical requirements
Non-clinical studies
  In vitro pharmacodynamic studies
  Identification of factors important for in vivo non-clinical studies
Clinical studies
  Pharmacokinetics
  Pharmacodynamics
  Clinical efficacy
  Clinical safety
  Extrapolation of indications
Immunogenicity assessment
  Immunogenicity and biosimilars
  Approaches to predict and reduce immunogenicity
  Clinical consequences of immunogenicity
  Assessing immunogenicity
    Screening and confirmatory assays
    mAb presence in samples
    Controls
  Assessing the neutralizing capacity of induced antibodies
  Different risk classes
A risk-based approach to developing biosimilar mAbs

US TAKES FIRST STEP TOWARDS A BIOSIMILARS APPROVAL PATHWAY

Guidance documents
User fees
Exclusivity
  Data versus market exclusivity
  Potential for evergreening
  Comments from consultation
Biosimilarity
  Is a demonstration of biosimilarity currently feasible?
  How should biosimilarity be evaluated?
  To what degree are clinical trials required?
  Clinical trial design
  Clinical trial endpoints
  Extrapolation of data to other disease indications
  Interchangeability
  Product drift
  Use of a non-US reference product
Pharmacovigilance
  Unique international non-proprietary names for biosimilars?
  Biosimilar drug labeling
  Pharmacovigilance
  Biosimilars approval in the US likely to be guidance-driven

APPENDIX

Abbreviations
US speaker details
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Biosimilars Update US$ 695.00 Apr, 2011 · 140 pages

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