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Flurry of FDA guidance firms up biosimilar policy – Courtesy (PMLive)
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The first biosimilar drug may have been approved in the US, but the FDA is still working on tools to help companies bring new products to market.

The regulator has just released a new Questions and Answers document – its fourth in as many weeks – to provide additional guidance on how it plans to regulate the emerging product category.

While biosimilars have been on the market in Europe for many years, it was not until March this year that the FDA approved the first biosimilar – Sandoz’Zarxio (filgrastim-sndz) -which is a copy of Amgen’s white cell stimulator Neupogen (filgrastim).

The latest Q&A document provides further details on how drug developers can demonstrate biosimilarity and – for the first time – the agency now indicates that it is possible for a biosimilar to be interchangeable with a reference product, in other words is so alike that it could be substituted for the reference drug even if the original brand is specified in a prescription.

However, the FDA goes on to say that “at this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability,” adding that it is still trying to determine what information it would need to make such as ruling.

The latest guidance also provides practical advice for biosimilar developers – for example detailing that clinical testing samples must be retained for five years and specifying the commitments for developers in terms of carrying out paediatric testing under the Pediatric Research Equity Act (PREA).

It also specifies that biosimilars must be in the same formulation as the original drug e.g. a freeze-dried powder for reconstitution or ready-to-inject solution, and provides additional guidance for the development and approval of antibody-drug conjugates (ADCs).

Earlier guidance has covered analytical methods to demonstrate biosimilarity and a Q&A document on the product development and marketing application process.

The operating environment in the US for biosimilar developers remains difficult – despite the creation of a regulatory framework. As a case in point, Amgen has just secured an injunction temporarily blocking sales of Zarxio on the basis of a technical dispute.

The FDA’s efforts to provide the finer details of guidance can only help to drive out uncertainty from biosimilar development and regulation and encourage the development of a market that – according to the FDA’s associate director for biosimilars Leah Christl – “can provide more treatment options for patients, and possibly lower treatment costs.”

Each of the guidances was developed to help industry more efficiently and effectively develop new biosimilars for patients in need, she writes in a recentblog post.

“Having more approved biosimilars is good for public health [and] FDA looks forward to continuing to help manufacturers develop these important products,” says Christl.

Express Scripts said recently it expects the US healthcare system to save around $250bn over the next decade as a result of the wider availability of biosimilar drugs.

Meanwhile, global sales of copycat biologics are projected reach $35bn by 2020 and Sandoz, which has more than 50% share of the world biosimilars market, is set to have a major share of this.

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