pharmabio consulting

Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications H. A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco
Published June 15, 2016 - No Comments
Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications H.A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco Biosimilars are regulated differently from small-molecule generic, chemically deri ...
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How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 1
Published July 26, 2012 - No Comments
How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 1 This is the first of a two-part series on the pre- and postapproval clinical safety of known EU-approved biosimilar therapeutic protein medicinal products. It compares and contrasts ...
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How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 2
Published July 26, 2012 - No Comments
How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 2 This two-part series provides insights into the new paradigm of biosimilar medicines based on approval and medical experience postapproval. It proposes a framework for the understand ...
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Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2
Published April 17, 2012 - No Comments
Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2 This article continues from Part 1 (see Regulatory Rapporteur, April 2012) in appraising the clinical safety of known EU-approved biosimilar therapeutic protein medicines pre-approval and postapp ...
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Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1
Published March 21, 2012 - No Comments
Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1 This article is Part 1 of a two-part paper appraising the clinical safety of known EU-approved biosimilar therapeutic protein medicines pre-approval and post-approval, and compares and contrasts ...
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Biosimilars Breaching Borders: How FDA and EMA Find Common Ground
Published March 8, 2012 - No Comments
By HA Dowlat and Karl-Ludwig Rost Human clinical pharmacology pharmacokinetic (PK) and pharmacodynamic (PD) studies are vital for many reasons, and uniquely useful in extrapolating the efficacy and safety of biosimilars. PK and PD studies are the most objective clinical trials, and are sen ...
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The importance and impact of the EU RMP and US REMS to risk-benefit assessments
Published January 28, 2011 - No Comments
The UE RMP is an engagement of wider scope than the US REMS, and is binding on a large set of medicines. The US REMS is compulsory only for some medicines, and can be limited to two years post product launch. The REMS concerns itself with communication of risk; with the prescriber informat ...
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The current status of biosimilar biologics – Part 1: An international perspective.
Published January 4, 2011 - No Comments
Europe set a precedent in 2006 by approving the first biosimilar medicines for human use. This led to the establishment of supporting laws and regulations in other major regions such as Canada in 2009, South Africa in 2009, Australia in 2009, Malaysia in 2009, the US in 2010 and a WHO inte ...
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The current status of biosimilar biologics – Part 2: Practical considerations in international development through European lessons learned
Published January 3, 2011 - No Comments
Biotech products coming off patent afford a window of opportunity to obtain a marketing approval for a “follow-on” by a new product developer. If the supporting data are sufficient to authorise interchangeability or substitution then the new product is defined as a similar biologic or ...
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Fresh Insights Into the Practicalities of Developing Biosimilar Biologics
Published December 5, 2010 - No Comments
Biotech products coming off patent afford a window of opportunity to obtain a marketing approval for a “follow-on biologic” by a new product developer. If the supporting data are sufficient to authorize interchangeability and substitution, the new product is defined as a similar biolog ...
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Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications H. A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco

How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 1

How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006—Part 2

Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 2

Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Part 1

Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

The importance and impact of the EU RMP and US REMS to risk-benefit assessments

The current status of biosimilar biologics – Part 1: An international perspective.

The current status of biosimilar biologics – Part 2: Practical considerations in international development through European lessons learned

Fresh Insights Into the Practicalities of Developing Biosimilar Biologics

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