Biosimilars: An evolution in the biopharmaceutical industry

by Michael J. McDowell, Eurofins Lancaster Laboratories, mmcdowell@lancasterlabs.com

Patents for 12 blockbuster biologic compounds, generating a combined $67 billion in sales, will expire by 2020. In February 2012, the FDA released its long awaited draft guidance on biosimilars, providing a regulatory framework for the approval of a biologic demonstrated to be similar to an already marketed product. The confluence of these two events has resulted in an evolution in the biopharmaceutical industry involving most players, but none more dramatically than a biopharmaceutical product testing laboratory.

Foremost in the FDA's approval process is the requirement for extensive testing and characterisation of the biosimilar to show that it is highly similar to the reference product. For innovator products, cGMP testing and extensive characterisation is loaded toward the back end of the drug development process after years of nonclinical and clinical studies. For biosimilars the extent of characterisation determines the need for additional nonclinical and clinical studies, thus moving testing to the front of the development process.

Over the past year, Eurofins Lancaster Laboratories has won many significant biosimilar testing programmes from new and existing clients due to its unique and compelling value proposition. Eurofins Lancaster Laboratories offers the extensive capacity, breadth of capabilities, innovator product expertise and global coverage to execute effectively on these very complex programmes. Clients have been pleased to find experts in Eurofins' Lancaster and Munich facilities to establish the often challenging cell based potency assays critical to these products. Clients have found state-of-the-art equipment, including CE, iCE, CD, LC-MS/MS, LC-TOF, MALDI-TOF, Q-TOF, TOF/TOF, and Orbitrap MS for orthogonal characterisation, including intact mass, peptide mapping, charge isoforms, carbohydrate sequencing, post translational modifications, and higher order structure.

This year, Eurofins Lancaster Laboratories has expanded its facilities, added extensive capital equipment, and attracted some of the brightest biochemists, cell biologists, and virologists to remain the first choice as a testing partner in this exciting, rapidly growing market.

For more information, visit www.LancasterLabsPharm.com

Kelly Valenti, Biochemistry Group Leader, performs CE analysis of a biosimlar product in support of an FDA filing.