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Australia Allows Pharmacy Substitution with Biosimilars Without Notice

Biosimilars are copies of the biologic medicines used to treat inflammatory and immunologic conditions such as rheumatoid arthritis, multiple sclerosis and cancer- potentially at lower costs. Although there are few on the market, the number of biosimilars entering the marketplace is exploding. In 2013, nearly 100 biologics had $66.3 million in sales. The RAND corporation estimates biosimilars will save $44.2 billion over 10 years (http://t.co/jlBnGFh5yN). At issue is whether patients or doctors will resist biosimilars in the care of conditions like RA. There are ethical and legislative discussions on whether a biosimilar can be substituted for the origian reference product by pharmacies, payors or governmental agencies.

Australia has broken from current international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.  The Alliance for Safe Biological Medicines surveyed physicians on the importance of biosimilar substitution notification and found it was considered "very important" or "critical" by 80% of U.S., 77% of European, 85% of Canadian, and 87% of Latin American physicians surveyed.

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The author has no conflicts of interest to disclose related to this subject