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10 years since the first biosimilar: FDA finally paves the way for approval of first biosimilar in the US

23 October 2014 Milena Izmirlieva

This month marks ten years since our same day analysis service was the first to report on the world's first biosimilar approval in Australia. Therapeutic Goods Administration (TGA) cleared copies of Omnitrope (a copy of Pfizer's Genotropin (sompatropin)). This was followed by similar approvals in the US and Europe, and it seemed certain that the US would in the not-too-distant future introduce an abbreviated approval pathway for biosimilars.

Omnitrope, manufactured by Sandoz (part of Swiss-based Novartis) was approved on a technicality. Its reference product, Genotropin, had been approved under the pathway for small chemical and not biologics which allowed Sandoz to use the abbreviated approval pathway for generics. But Europe, and soon after, Canada and Japan introduced an abbreviated procedure for biosimilars approval. Surely the United States would not be far behind, I thought at the time. That was back in 2006.

The main difficulty for US drug regulation through the Food and Drug Administration (FDA) is that the agency can not create an abbreviated approval process because there was a need for one - it required a special authorisation from the US Congress to develop and introduce an abbreviated pathway for biosimilars. The FDA was finally authorised to review biosimilars by Congress as part of the Biologics Price Competition and Innovation Act (BPCIA) of 2009. At that time, there seemed to be significant momentum to finally have biosimilars approved under an abbreviated procedure.

As I wrote a while back, states began to introduce their own legislation in anticipation of the first approvals - some allowing substitution with biosimilars at the pharmacy level, others stating that substitution should be limited and only approved in cases when the FDA explicitly states that the biosimilar product is interchangeable with the originator.

Yet, more than a year after most states passed the relevant biosimilars legislation on substitution, the approval of the first biosimilar in the US is still just as illusive as it has been these past few years. However, it seems that things are about to change.

FDA published Purple Book
Last month the FDA announced the publication of the so called Purple Book - a new database which will include biosimilar and interchangeable biological products approved by the regulator under the Public Health Service (PHS) Act. The Purple Book will also include information about the date of FDA approval, the end of data exclusivity, and if a product is deemed to be biosimilar to or interchangeable with a reference product. Separate lists will be included with biological drugs approved by the Center for Drug Evaluation and Research (CDER) and those processed by the Center for Biologics Evaluation and Research (CBER), thus allowing the database to capture the older biologics some of which may have been approved under the approval procedure for small chemical drugs. Significantly, biosimilars approved by the FDA will be listed under the reference product against which their biosimilarity was established.

Pressure is piling on the FDA
Meanwhile, Sandoz' biosimilar version of Amgen's neutropenia drug Neupogen (filgrastim) was filed for approval in the US in July. No timeline for FDA approval was provided at the time. However, Sandoz said that the FDA had accepted the application and its filing was the first under the new biosimilar pathway created under the BPCIA. And in August, Celltrion (South Korea) filed for FDA approval for its biosimilar version of Remicade (infliximab; Johnson & Johnson, J&J, US) - once again using the abbreviated pathway under the BPCIA. Whether the FDA is ready or not - and just as importantly whether the US public and legislators are ready or not - for biosimilars, the clock is ticking.

The FDA undoubtedly still has a long way to go: it is yet to provide guidelines in terms of key issues such as indication extrapolation for biosimilars, interchangeability and labeling of biosimilar products. In the grand scheme of things the Purple Book is one tiny step towards finalising the approval pathway in the US, but it is nonetheless a significant one. What it should be telling naysayers is that biosimilars will eventually see the light of day in the US and that this day would be sooner rather than later.



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