Explainer: what are biologics and biosimilars?

[AussieNeil]

Biologics are medicines made from living organisms and their products to produce therapeutic proteins and polypeptides. They are better for treating cancer cells than older chemotherapy treatments that just target fast growing cells, because they are designed to lock onto the specific body cells that are causing the cancer. With about half of the biologics on the market about to have their patents expire, there's a developing market for biosimilars, for example Rituximab in the case of CLL treatment. Veysel Kayser, Associate Professor of Pharmacy and Iqbal Ramzan, Dean & Professor of Pharmacy, both at the University of Sydney explain more:

theconversation.com/explain...

Thomas Morrow, MD and Linda Hull Felcone explain how biologics differ from chemically derived drugs in ways that affect their cost, production, administration and clinical efficacy here:

ncbi.nlm.nih.gov/pmc/articl...

Obinutuzumab, Ofatumumab, Ibrutinib, Idelalisib, Duvelisib, ABT-199 and many other biologics used to treat CLL are described in Tanya Siddiqi and Steve Rosen's two part review:

Novel biologic agents for non-Hodgkin lymphoma and chronic lymphocytic leukemia-part 1

ncbi.nlm.nih.gov/pubmed/257...

Novel biologic agents for non-Hodgkin lymphoma and chronic lymphocytic leukemia-part 2

ncbi.nlm.nih.gov/pubmed/259...

Biologics are a huge and growing market; the battle over biologics helped stall the Trans Pacific Partnership (TPP), according to Deborah Gleeson, Lecturer in Public Health at La Trobe University, Australia and Ruth Lopert, Adjunct professor, Department of Health Policy & Management at George Washington University, USA. They state that a key issue is the length of the data-exclusivity period for biologics, with the biopharmaceutical industry lobby in the United States seeking 12 years of market exclusivity for biologics, much longer than the periods legislated in the other countries involve in TPP negotiations. They note that "Data exclusivity provides an absolute monopoly that, unlike a patent, can’t be revoked or challenged in court":

theconversation.com/how-the...

Neil

Photo: GoldenEye Lichen (Teloschistes chrysophthalmus), with thanks to Jay for the identification

[jules_c]

Thanks, good information. Jules

[Psmithuk]

Oh dear - in a hurry I read - 'about to have their patients expire' - will go back and read properly when I've more time!

[Peggy4]

Thanks Chris. I think it's one to remember. A lot of us (myself included) can be put off asking the questions for fear of offending. Peggy.