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:
Key features
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
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
