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1st Annual Biopharmaceuticals Meeting

Next generation and biosimilar monoclonal antibodies – essential considerations towards regulatory acceptance in Europe

Date: 03 - 04 February 2011

Location: Freiburg, Germany

  • Newest information on regulatory guidelines
  • Regulatory expectations presented by experts from agencies
  • Industry experience
  • Panel discussions
  • Manifold networking opportunities

This meeting was initiated to provide a platform where regulators, scientists, regulatory affairs professionals, manufacturers and service providers meet, exchange knowledge and views related to the development of monoclonal antibodies, regardless whether they are newly developed, next generation (or follow-up) or biosimilars.

Followings were discussed:

Innovation is introduced by manifold options i.e. through development of new monoclonal antibodies for new indications, by reducing the dose frequency for authorized products or by introducing a new route of administration allowing self-administration.

On the other hand, development of biosimilar monoclonal antibodies has the potential in reducing the health care costs.

Extensive experience has been accumulated in the manufacture and testing approaches utilized in the development of monoclonal antibodies.

The processes to establish productive clones, to manufacture at higher yields, to humanize antibodies on one hand and the test methods to characterize these molecules on the other hand have been evolved tremendously. The available instrumentation more and more provides confidence that the products may be well characterized. However, despite all of these achievements a monoclonal antibody remains a complex construct which is not fully understood as to how specificity, function and structure relate to their clinical mode of action, efficacy and safety.

Other than in the treatment with erythropoietin, growth hormones or G-CSF, monoclonal antibodies are not used to replace or substitute proteins which are naturally occurring but lacking in the individual patient. Monoclonal antibodies instead introduce new pharmacological principles in large indications requiring investigation in conventional large pivotal trials. Each individual antibody is considered an individual molecule for which proof of efficacy and safety is required in this indication based on pivotal endpoints and for the dose claimed.

Consequently, critical questions regularly arising include:

  • what if the manufacturing process is changed, improved, transferred or based on another clone?
  • what to investigate for a new dosing regimen following an improvement of the functional properties of the antibody?
  • what is required if the antibody is administered in a new route of administration?
  • is there an option to accelerate the development of a next generation or biosimilar antibody?
  • which experience is needed to demonstrate that the resulting antibody is efficacious and safe?

Acceleration of development of monoclonal antibodies is in the interest of all involved stakeholders. However, care needs to be taken to ensure that acceleration does not lead to overlooking potential risks.

This meeting was chaired by Prof. Johannes Löwer and and aimed at the exchange on the common understanding of scientific and regulatory requirements as a prerequisite of successful antibody development.

The report of this meeting has been published in MAbs. 2011 May-Jun; 3(3): 223–240.