Immunology and Biotherapies

Perspective from The New England Journal of Medicine — Progress and Hurdles for Follow-on Biologics

 

The challenges to achieving savings from follow-on biologics are large but not insurmountable. First, market-entry hurdles should be low enough to ensure that enough companies compete to affect prices. Public investment in technological advances that can support biosimilar development, such as advancing knowledge about glycosylating human proteins in yeast, can aid all manufacturers. The FDA can help by promulgating product-specific guidance on how companies can demonstrate biosimilarity or interchangeability, to reduce the disadvantages for the first companies to try. Legislators may also need to reexamine the process for exchanging information about potentially infringing patents, to ensure that innovator manufacturers cannot unreasonably delay the process in order to extend their market exclusivity, and to prevent biosimilar manufacturers from entering into anticompetitive settlements. Such settlements have bedeviled the generic small-molecule drug industry but, since 2003, have had to be reported to the Federal Trade Commission for evaluation of their anticompetitive effects. This requirement may have to be extended to biologic drugs.

Innovative approaches will be required to ensure mandatory, rigorous postapproval research on the safety and effectiveness of biosimilars compared with their innovator predecessors in order to promote confidence in these new products. Over the long term, attention to both these areas will help ensure that U.S. patients benefit from appropriate price reductions for older biologic drugs that are essential for their clinical care. At the same time, fair but appropriately limited periods of exclusivity will reward the innovators of the original products while also spurring them to create new products rather than prolong exclusivity rights over older ones long after such monopolies should have come to a natural end.

Via Krishan Maggon

(2014). Physicochemical characterization of Remsima®. mAbs: Vol. 6, No. 5, pp. 1163-1177. doi: 10.4161/mabs.32221

Via Krishan Maggon

Product and Process Innovation in the Development Cycle of Biopharmaceuticals #biologics #biologicals mAbs #biopharma
http://t.co/yV97kw0IAy

 

Summary: Compared to small-molecule drugs, biopharmaceuticals require significantly more complex processes for R&D and production. In this work, we tracked and categorized patented biopharmaceutical technologies along the innovation cycles timeline using International Patent Classification (IPC) codes to show that the biopharmaceutical R&D process has been evolving from the conventional pattern of innovation. Our study builds on the latest research on innovation theories to provide empirical evidence that demonstrates reshaping of innovation processes through utilization of scientific knowledge. Based on our results, we provide strategic perspectives on the biopharmaceutical industry.

 

Teaser: We tracked and categorized patented biopharmaceutical technologies along the innovation cycle timeline using IPC codes to show that the biopharmaceutical R&D process has been evolving from the conventional innovation pattern.

Via Krishan Maggon

The development of complex biosimilars, such as monocolonal antibodies and fusion proteins, is an exceptionally challenging technical undertaking.  Unlike traditional small molecule pharmaceuticals which are essentially formula driven chemicals, complex biologics are much larger, multifaceted molecules.  To illustrate the relative levels of complexity, a traditional aspirin molecule can be likened to a bicycle, while a simple biologics (such as human growth hormone) can be likened to an automobile.  A complex biologic, such as a monoclonal antibody (mAb), meanwhile, is analogous to a modern commercial airliner.

 

Due to the complexity of mAb’s and fusion proteins, the requirements for establishing that a biosimilar molecule is biologically comparable to the original innovator molecule require comprehensive and exquisite science. The BioSymphony model for biosimilars development was specifically designed to address those scientific and regulatory requirements, within a framework of rapid, low-cost, high quality execution, as illustrated below.

 

  

© 2015 Oncobiologics, Inc.

 

 

Via Krishan Maggon