Biosimilars: An evolution in the biopharmaceutical industry
Patents for 12 blockbuster biologic compounds, generating a combined $67 billion in annual 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 In February 2012, the FDA released its long-awaited draft guidance on biosimilars, providing a regulatory framework for the approval of a biologic demonstrated to be similar to an already marketed product.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 characterization of the biosimilar to show that it is highly similar to the reference product. For innovator products, cGMP testing and extensive characterization is loaded toward the back end of the drug development process after years of nonclinical and clinical studies. For biosimilars, the extent of characterization determines the need for additional nonclinical and clinical studies, thus moving testing to the front of the development process.
For the past several years, Eurofins Lancaster Laboratories has won many significant biosimilar testing programs 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 programs. 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, LCTOF, MALDI-TOF, Q-TOF, TOF/TOF, and Orbitrap MS for orthogonal characterization, including intact mass, peptide mapping, charge isoforms, carbohydrate sequencing, post translational modifications, and higher order structure.
Our experience working with various clients on biosimilars targeting many of the blockbuster innovator products has shown these programs to be very method development intensive. The methods that exist for the innovator products are difficult to obtain or lack sufficient detail for a quick method establishment in the laboratory. It is our ability to work through method development challenges early in the project that has allowed us to meet the rigid timelines and manufacturing schedules inherent in biosimilar development programs.
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