Pre-Conference Workshop, Tuesday 28 February 2012

Overview:

Regulations for biosimilars are currently evolving in Europe, the US, and in many emerging countries. Europe has been in the forefront of Biosimilar regulation since 2001 when the EU created a pathway for the approval of Biosimilars. The EMA has since issued three overarching biosimilar guidelines, describing (I) general requirements, (II) quality, and (III) non-clinical and clinical development, and, in addition, a number of product class specific guidelines.

The hurdles are high for a successful registration of Biosimilars in Europe. So far, seven development programs for three product classes (somatropin, epoetin, filgrastim) have been completed successfully, whereas four programs have failed (interferon alfa, insulin, interferon beta, epoetin). Monoclonal antibodies are structurally even more complex, and once these medicines go off patent, they will inspire a next wave of follow-on developments. Our ability for thorough characterization has advanced tremendously, and the value of non-clinical data in the development of mAbs has been recognized. The use of quality-by-design principles, high-producer cell lines, and single usemanufacturing technologies may significantly reduce development timelines and costs.

The workshop will run from 9.00 AM - 3.30 PM and will include refreshments and lunch.