Biosimilars: FDA intervenes to address pervasive challenge of patent web with new Purple Book disclosure requirement

“In a small yet significant change, the US FDA has addressed part of the complex of patent webs causing undue delay in access to biosimilars. The starkest example for the delay in biosimilar launch shall remain adalimumab, where patent challenges have led to the US launch lagging EU launch by five years. In this context, the current change requiring disclosure of patent and exclusivity information on the purple book post-pre-litigation information exchange is a substantial one that minimizes the threat of new patent skeletons emerging to derail biosimilars. While this far from the nature of transparency common for small molecules on the orange book, the development provides respite for biosimilar developers nevertheless.”

The US Government and the FDA, over the years, have been taking significant steps towards improving biosimilar development timelines, expediting regulatory approvals, and creating a favorable regulatory environment for more biosimilars to enter the market and improve patient access. Under a new law called “Consolidated Appropriations Act, 2021", signed by the erstwhile President Trump on December 22, 2020, Section 325 pertains to Biological Product Patent Transparency and requires the US FDA to disclose patent and exclusivity related information of licensed biological drugs within 30-days of disclosure of information to biosimilar companies that have sought such information under the statutorily prescribed pre-litigation exchange of information. The Act requires the FDA to update biologicals' current listing with the said information by June 2021.

The law would still require the first biosimilar developer for any biological molecule to conduct their diligence and follow the previously practiced 'Patent Dance' route. However, once disclosed, the patents would be made publicly available on the Purple Book database and can be accessed by any subsequent biosimilar makers. This is an encouraging move. It would make such information easily accessible and accelerate the biosimilar development process since not all biosimilar companies will be required to access such information under the previously time-intensive diligence and confidentiality route. Numerous patents cover a single biologic molecule on the manufacturing process, cell lines, molecular structure, and more. Inaccessibility to an extensive listing of patent information can leave room for a potential patent infringement and delay the development launch if companies enter into patent litigation. This positive development would help the Purple Book gradually evolve into a more comprehensive resource with full patent and exclusivity information akin to the Orange Book. The Orange Book serves as the go-to resource with complete patent and exclusivity information for all small molecule drugs on approval. Even with the current change, the timing of listing similar information on the Purple Book falls substantially behind the current practice in the Orange Book, where no litigation trigger is required for such listing, and transparency is the norm. We are encouraged by the development, which simplifies crossing the complex patent web, but look forward to follow-up action that finally leads to complete transparency from the date of approval of the innovator biological drug.

The law also requires the FDA to list licensed biologicals exclusivity information, which can help developers plan their biosimilar development and commercialization timelines. More details on this are available here in our PharmForward post.

In March 2020, insulin and certain other biologic drugs that were historically approved and regulated as drugs under the Food Drugs and Cosmetics (FD&C) Act were transitioned to a biological drug under the (Biologics Price Competition and Innovation Act of 2009) BPCIA pathway, and the move opened a new pathway for manufacturers to seek FDA approval of the transitioned molecules and bring biosimilar and interchangeable versions of these products to market, facilitating greater competition. The latest Congress mandate is another step to improve access to biosimilar versions of critical, often life-saving drugs and benefit patients through a price-based competition.

The step would also work towards improving future biosimilar development timelines, particularly pertinent when biosimilar pipelines have been significantly impacted by COVID-19 led trial halt, regulatory delay, and more. Previously covered in our 2020 Roundup, new biosimilar approvals in 2020 dropped to a low of 3 from the remarkable level of 10 approvals in 2019, mainly due to the impact on regulatory activities, which were primarily concentrated on COVID-19 related measures. It would give the required impetus to the 2023 and beyond biosimilar pipeline since multiple molecules are due for patent expiration (e.g., Omalizumab, ranibizumab, denosumab, etc.), and patent-associated information can be accessed publicly beginning from June 2021.

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