Biosimilars firms hope US and EU guidance will stimulate markets

Biosimilar manufacturers are awaiting guidance from US and EU regulators which could help stimulate uptake and development of these near-copy biologic medicines.

Despite a US law creating an abbreviated development pathway for biosimilars in 2009, there are only two FDA-approved biosimilars on the market, compared with more than 20 in the EU.

The US regulator is expected to publish guidance this year on interchangeability of biosimilars with the originator product – and biosimilars firms hope that the document will back switching patients from originator products, to biosimilars.

This would boost sales by allowing all patients to use biosimilars, not just those who are beginning treatment.

The FDA is also due to publish guidance on statistics used to support regulatory filings, following a document earlier this year that gave advice on labelling, the Medicines for Europe annual biosimilars conference heard.

The FDA’s guidance on labelling was well received by biosimilar manufacturers as it recommended the same label information as the originator product, aiming to give doctors confidence in using the cheaper versions of biologic drugs.

Ariel Dora Stern, assistant professor at Harvard Business School, said in a presentation: “The US market is large and could attract many entrants.

“In the US some hospitals are already switching to lower cost products. But the FDA recommendations -in particular a decision on interchangeability – will have a lasting impact on the US market.

“The FDA recommendation on interchangeability is going to happen at a national level. But each of the 50 states have pharmacy boards. The complexity of the situation is increased by the federal system that we have.”

Bertrand Liang, CEO of US biosimilars development firm Pfenex, told pharmaphorum in an interview on the sidelines of the conference that the European Medicines Agency could reduce regulatory burden on companies developing biosimilar granulocyte colony stimulating factor (GCSF).

Used to treat low white blood cell count following cancer chemotherapy, biosimilar GCSF is already established on the European market.

Liang said that manufacturers are hoping the EMA will require only bioanalytical data in guidance, and not expensive clinical trial data to demonstrate biosimilarity with the originator drug.

There are huge potential savings, that could stimulate biosimilar manufacturers to produce more GCSF products such as filgrastim. He said: “Nobody knows how the EMA is going to fall.”

The EMA suggested the idea in a concept paper published last summer, and a firm proposal is due soon after a consultation that ended in October.

Related stories:

Biosimilars could save US and EU $110m by 2020 – report

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