The agency issued its “purple book” this week, explaining that collating details of biopharmaceuticals approved by the Center for Biologics Evaluation and Research (CBER) and the Centre for Drug Evaluation and Research (CDER) will help doctors and patients determine interchangability.
“The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.
The Food and Drug Administration (FDA) added that: “The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product.”
While this may well be the case, at present the list is not much use for biosimilars firms which have bemoaned the lack of an equivalent to the small molecule drug industry’s so called “orange book” that details approved drugs and associated patents.
While the entries for CBER products include the date they were licensed, there are no details of either the date the product was first licensed or when the exclusivity period is due to expire.
The CDER list also lacks details with only the entries for Amgen’s Neupogen (filgrastim), Genentech’s Perjecta (pertuzumab) and and Teva’s Granix (tbo-filgrastim) including first approval and exclusivity expiry dates.
Neither list details product interchangability. However, according to the agency “Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.”
More details but no patents to follow
The FDA positions the purple book – which it is not required to compile unlike the orange book – as a work in progress, which is also the view of patent expert Stacie Ropka, from law firm Axinn.
Ropka told Biopharma-Reporter.com that: “The purple book provides a single place to find details of all biologics that have been approved and to identify products for which data exclusivity has expired or when it will expire.
Ropka added that: “Currently, only about half of the columns have been populated. I would expect the other columns, such as the “Reference Product Exclusivity Expiry Date” to be populated relatively soon and the other columns to be populated as FDA grants approvals to biosimilars. Thus, as the biosimilars market develops in the US, the purple book will be more useful.
"It is my understanding, however, that at present there are no plans to include patents like in the Orange Book” she said.