Are biosimilars interchangeable in Europe?

On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety or efficacy in individual patients upon a switch. Our conclusion is that biosimilars licensed in the EU are interchangeable.

Why are the EU and US biosimilar markets so different?

The differences between the US and EU biosimilar markets This is due to a difference in the patent landscape, with some EU patents ending earlier and some originator companies generating more patent barriers in the US.

How many biosimilars are approved in Europe?

In the EU today, 58 biosimilars are approved for 16 reference products (GaBI, 2020a) (see Figure 1). In the United States, the Biologics Price Competition and Innovation Act (BPCIA), part of the Affordable Care Act of 2010, created a US biosimilars pathway.

Are biosimilars equivalent?

Biosimilars are clinically equivalent to their reference medicines. They are just as safe and just as effective as the biologic they are based on. Biosimilars are often available at a much lower cost than their biologic counterpart. Like all biologic medicines, a doctor prescribes a biosimilar to his or her patient.

How many biosimilars are interchangeable?

The FDA has approved 2 interchangeable biosimilars—biosimilars that pharmacists could substitute interchangeably with reference drugs—since July 2021, but manufacturer-developers are seeking interchangeable status for about 7 other biosimilars, according to Jeff Casberg, MS, RPh, vice president of Clinical Development …

What is the brand name for the first biosimilar that was approved in the EU?

Omnitrope®
The first biosimilar medicine, Omnitrope® (biosimilar recombinant human growth hormone [rhGH]; Sandoz, Kundl, Austria), was approved in Europe by the EMA in 2006.

How many biosimilars are approved?

FDA has approved 33 biosimilars corresponding to eleven different reference products.

When was the first biosimilar approved in Europe?

2006
Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006 [2].

What is biosimilar interchangeability?

An interchangeable biosimilar product is a biosimilar that meets additional requirements outlined by the law that allows for the FDA to approve biosimilar and interchangeable biosimilar medications.

Are biologics and biosimilars the same?

Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.

Why are biosimilars not interchangeable?

To be approved as interchangeable, research must show that the biosimilar drug produces the exact same results in an individual patient—meaning that a person can take either drug and expect the same symptom reduction and same side effects. To date, no biosimilars have been approved as interchangeable.

What is the difference between biosimilar and interchangeable?

An interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act.