update

Lack of US FDA biosimilars guidance not holding back global dev say EMA meeting attendees

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Food and drug administration, Fda

Lack of US FDA biosimilars guideance not holding back global dev
Lack of US FDA biosimilars guideance not holding back global dev
The lack of US FDA biosimilars guidance is not holding back development say BioPharmas and regulators who met with the EMA this week.

On Thursday the European Medicines Agency (EMA) met with national regulators and members of the biopharmaceutical industry to discuss revisions to guidelines on the quality and testing requirements for biosimilar drugs.

BioPharma-Reporter.com listened to the live webcast and asked the attendees if they thought lack of FDA guidance on biosimilars is holding back the development globally. And the response was a resounding “no.”

Richard Markus from Amgen was first to reply, explaining that: “No I don’t think it does. There are a lot of people here [at them meeting] developing biosimilars with global intent who are having meetings with the FDA.

Robin Thorpe from the EMA’s Biosimilar Medicinal Products Working Party (BMWP) was of a similar view. He said that: “The US FDA has actually taken a very active path after the 2010 law was passed. Europe has been ahead for a long time but they [the US FDA] will catch up it is just a matter of timing​.”

Prof Andrea Laslop from the Austrian Medicines Agency agreed adding that: “We have seen a sort of revival of collaboration between EMA and FDA on biosimilar mAbs and while that procedure does not end in similar advice I believe that such discussions benefit both agencies.”

The EMA event – which was attended 70 including EMA staff, regulators from all over the world, drug firms including Pfizer, Sanofi, Roche, Novartis, UCB and Abbvie and  generics players like Teva, Sandoz, Mylan – focused on three draft guidance document issued this year.

The first guidance – published in May​ – sets out the basic requirement sets out the basic information required for firms wishing to develop biosimilar products, including detailed instructions on the choice of reference product and the principles required to establish biosimilarity.

The other two guidance documents discussed at the event cover non-clinical and clinical assessment requirements​ and issues related to active ingredient quality​.

EMA spokeswoman Sophie Labbé told BioPharmaReporter.com that: "The aim of this workshop was to bring together regulators and stakeholders to discuss the three draft revised guidelines, including comments received so far during the public consultation.​"

She added that presentations made at the event will be available online and the revised guidance documents will be published in due course.

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