Biosimilar biologic drugs: a new frontier in medical care.
Physicians in training are expected to be aware of the newest developments in patient care. Biologic therapies have changed treatment of many diseases by specifically targeting key disease mediators, but patient access to these therapies can be limited. As patents for the first biologic therapies are expiring, the development and approval of products known as biosimilars is rapidly gaining momentum. A biosimilar is a biologic product that is highly similar to a reference product (a licensed biologic product), notwithstanding minor differences in clinically inactive components. Biosimilars undergo a thorough evaluation compared with the licensed biologic and need to demonstrate comparable clinical pharmacokinetics, efficacy, and safety including immunogenicity. Understanding the processes for new drug approvals, the rigorous evaluation of biosimilars, and considerations about their selection and use can help recently trained physicians to make informed treatment decisions and improve patient outcomes.
a Fox Chase Cancer Center , Temple University Health System , Philadelphia , PA , USA.
Daniel M
DM
Geynisman
b Department of Medical Oncology , Dana-Farber Cancer Institute , Boston , MA , USA.|c Department of Medical Oncology , University Hospital 12 de Octubre , Madrid , Spain.
Guillermo
G
De Velasco
d Biotechnology Clinical Development , Pfizer Inc , Cambridge , MA , USA.
K Lea
KL
Sewell
e Global Established Pharma Medicines Development Group , Pfizer Inc , New York , NY , USA.
Ira
I
Jacobs
D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D017277:Drug Approval; D019317:Evidence-Based Medicine; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D059451:Biosimilar Pharmaceuticals
Biosimilars; biologic therapy; drug development; regulatory approval