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
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, firstname.lastname@example.org
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,"
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c, accessed Oct. 13, 2012.
4. EMA, Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical Use (London, June, 2012).