20 September 2016Biotechnology

AIPPI 2016: Bright future for biosimilars

In a session moderated by Dominic Adair of Bristows, panellists at the 2016 AIPPI World Congress in Milan yesterday discussed biosimilars substitution and interchangeability.

The panel consisted of Fritz Reiter from Sandoz, Mei-Hsin Wang from China Biomedical & Technology Application Association, and Bryan Zielinski from Pfizer.

“When we’re looking at substitution, we’re talking about biosimilars and originator products being substituted,” Adair said, kicking off the topic.

A substitution would involve the dealing of a biosimilar medication at the pharmacist and clinician’s level, where the patient is given the alternative medication to the biologic.

Biosimilar substitution and interchangeability would allow a patient to use a different, cheaper drug to the biologic but which has the same outcome.

Zielinski explained that the US Food and Drug Administration (FDA) has not approved any biosimilar for substitution.

He said in the discussion: “The biosimilars would have to be on the market for a long enough time before the FDA approves.”

Reiter added that the FDA has not agreed on the requirements of interchangeability.

Adair said: “If you can achieve interchangeability, the whole market becomes yours. However, no one has been able to do that yet.”

The current status of biosimilars approval differs from country to country with the US having approved three, the EU 21, Japan nine, South Korea six, and Australia 11.

Zielinski added: “I think we’ll see a growing use of biosimilars in the US as we’ve seen in the EU.”

Other topics such as the complexity of biosimilars, challenges to the healthcare system, data and market exclusivity, as well as regulatory issues, were also discussed.

The 2016 AIPPI World Congress ends today.

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