Pharmaceutical Technology Europe - November 2012 - (Page 8)

EU Sets Guidelines for Biosimilar Monoclonal Antibodies The European Union has reached an important stage in its efforts to make the region a biosimilars production centre. EMA has finalised a guideline on biosimilar monoclonal antibodies (mAbs) and is drafting another one on the key issue of quality of biosimilars. EMA has issued a series of product-specific guidelines. These guidelines cover biosimilars for insulins, somatropins, granulocytecolony stimulating factor (G-CSF), epoetins, low-molecular weight heparin and interferon-α (3). However, the guideline on mAbs is seen as technically the most challenging because of the complexity of the drugs in terms of their biological structure, range of clinical indications and potential for unwelcome adverse effects, particularly immunogenicity. The mAb guideline was published at the same time as a separate one specifically on immunogenicity in mAbs, which EMA points out are known to be associated with unwanted immunogenicity (4). Because the mAb guideline concentrates primarily on safety and efficacy, quality matters are being covered by the general quality guideline for biosimilars, currently in the consultation stage. The mAb guideline’s overall aim is to lay down general principles for nonclinical and clinical studies on any potential differences between a biosimilar mAb and a reference mAb and how much these differences may amount to a dissimilarity between the two products. The guideline recommends a step-wise approach, with both in vitro and in vivo studies being conducted on a case-by-case basis. Extrapolation of clinical efficacy and safety data to other indications of the biosimilar, based on the overall evidence from the comparability exercise, would be acceptable, according to the guideline. In its draft guideline on quality of biosimilars, EMA states that, “it is not expected that all quality attributes (between the biosimilar and the reference product) will be identical and minor differences may be acceptable, if appropriately justified.” In the mAb guideline, the agency points out that assays have been developed in recent years allowing more in-depth characterisation of complex proteins both at the physicochemical and functional levels. These assays have enabled more effective assessment of minor quality differences in manufacturing processes for mAbs. Nonetheless, EMA warns that “in the current state of knowledge it may be difficult to interpret the relevance of minor quality differences” when comparing a biosimilar with a reference mAb. PTE Sean Milmo is a freelance writer based in Essex, UK. seanmilmo@btconnect.com. 2 EXTRACTABLES & LEACHABLES 9 ALZHEIMER’S DISEASE 5 NEWS 10 BLOGS 7 QUALITY BY DESIGN 11 TECHNOLOGY 8 BIOSIMILAR mAbS 12 STAFF Ingram Publishing/Thinkstock Images

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - November 2012

Pharmaceutical Technology Europe - November 2012
Contents
Cover Story: Examining the Growing Challenge of Extractables & Leachables: An Industry Roundtable
News Bites
Applying Quality by Design for Extended-Release Hydrophilic Matrix Tablets
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
Will Europe Discourage the Launch of New Alzheimer’s Drugs?
Blogs: Roche Under Investigation; Q3 Financial Reports
Top IT Technologies

Pharmaceutical Technology Europe - November 2012