EU Sets Guidelines for Biosimilar Monoclonal Antibodies - Pharmaceutical Technology

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EU Sets Guidelines for Biosimilar Monoclonal Antibodies
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

Pharmaceutical Technology
Volume 36, Issue 11, pp. 42-45

A global enterprise

Because of the high expenditure necessary on manufacturing facilities, development, and pharmacovigilance activities, biosimilar producers are looking for ways of curbing costs. Merck Serono and Dr. Reddy's are among pharmaceutical companies that have formed an alliance in the production and development of biosimilars, mainly mAbs, to spread the risk. DSM of the Netherlands and Crucell, a Dutch subsidiary of Johnson & Johnson, have reduced the scope of Percivia, their US-based joint venture in biosimilars by ending in-house product development.

"In order to reduce the overall development costs, we need in the EU and in the US a scientific framework which allows global development," says Kox. The European Commission has appeared to be acknowledging the need for global development of biosimilars when it recently announced it would accept applications for approvals of biosimilars containing data from reference products that come from outside the EU.

"[With this announcement] a new regulatory paradigm is born, which is a great achievement after years of discussion," says Kox. "The issue of the reference product is not the only one to achieve global development. But for companies to be able to use data from tests from reference products that are not sourced from the EU constitutes a major and far-reaching regulatory breakthrough."

The European Commission has yet to finalize details on how a comparability exercise with a reference product outside the EU would work. But the decision does seem to show that the EU is intent on continuing to take a lead on biosimilar regulatory matters without waiting for US guidance on the development of biosimilars to be formally adopted.

Sean Milmo is a freelance writer based in Essex, UK,


1. EMA, Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies—Non-Clinical and Clinical Issues (London, June, 2012).

2. EMA, Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues, revision 1 (London, May 2012).

3. EMA, "Multidisciplinary: Biosimilar,", accessed Oct. 13, 2012.

4. EMA, Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use (London, June, 2012).


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