Table 1.

Differences between Generics and Biosimilars

	Generics	Biosimilars
Product characteristics	Small molecules	Large complex molecules
	Often very stable	Stability requires special treatment
	Typically taken orally	Devices are often the differentiating factor
Production	Produced by chemical synthesis	Produced in living organisms
		Highly sensitive to manufacturing changes
		Often high production costs
Development	Very limited clinical trials (only bioequivalence studies)	Significant research and development (i.e. cell lines)
		Clinical trials to a limited extent
Regulation	Shorter registration procedures in Europe and the United States	Regulatory pathway defined by the EMA
	Usually enjoy “substitutability” status	“Comparability” status
		In the United States, law approved in March 2010, in force in October 2010
Marketing	No or limited detailing to physicians	Detailing to (specialist) physicians required
	High price reduction	Pharmacists may not substitute
	Market substitution in pharmacies	Lower price reduction
		Price sensitivity is product specific