Postmarket policy considerations for biosimilar oncology drugs

Summary Oncology biological products are some of the most expensive drugs on the market and are a growing financial burden on patients and health-care systems. By 2020, numerous major biological cancer drugs will lose their patent protection allowing follow-on competitors, known as biosimilars, to e...

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Bibliographic Details
Published in:	The lancet oncology 2016, Vol.17 (1), p.e31-e38
Main Authors:	Renwick, Matthew J, MSc, Smolina, Kate, PhD, Gladstone, Emilie J, MPH, Weymann, Deirdre, MA, Morgan, Steven G, Prof
Format:	Article
Language:	eng
Subjects:	Antineoplastic Agents - economics Antineoplastic Agents - therapeutic use Biological products Biosimilar Pharmaceuticals - economics Biosimilar Pharmaceuticals - therapeutic use Cancer Chemotherapy Competition Drug Costs - legislation & jurisprudence Drug Substitution - economics Drug Utilization - economics Drug Utilization - statistics & numerical data Drugs Economic Competition Europe FDA approval Federal regulation Health Policy Hematology, Oncology and Palliative Medicine Humans Legislation, Drug Licenses Licensing Market penetration Oncology Pharmaceutical industry Pharmacies Practice Patterns, Physicians Trends United States
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Summary:	Summary Oncology biological products are some of the most expensive drugs on the market and are a growing financial burden on patients and health-care systems. By 2020, numerous major biological cancer drugs will lose their patent protection allowing follow-on competitors, known as biosimilars, to enter the market. Clinical and regulatory considerations for biosimilars have begun to harmonise in Europe and the USA to help to define and streamline the pathway for biosimilar market authorisation. Yet, substantial international variation still exists in the pricing and market uptake of approved biosimilar oncology drugs. Differences in national postmarket policies for biosimilars might explain these disparities in pricing and uptake. In this Policy Review, policy approaches to competition between biosimilars and originators used by seven European countries—Belgium, France, Germany, Italy, the Netherlands, Norway, and the UK—and the USA are discussed, chosen because these countries represent a variety of postmarket policies and build on conclusions from previous work. We discuss these policies within the context of interchangeability, physician prescribing, substitutability, pharmacist dispensing, hospital financing and tendering, and pricing.
ISSN:	1470-2045 1474-5488