Opening the door to biosimilar competition starts with breaking down the patent barrier, says Christine Simmon, JD.
With multiple issues preventing biosimilar-induced price reduction, Christine Simmon, JD, is working to remove legal hurdles and foster patent transparency for biosimilar manufacturers.
Simmon is senior vice president of policy and strategic alliances for the trade association Association for Accessible Medicines (AAM). She is also executive director of the Biosimilars Council a division of the AAM, which represents many large drug manufacturers.
Many of the 17 biosimilars currently marketed in the United States have had to face ruthless legal disputes with reference product manufacturers that fought to keep biosimilar competitors off the market for as long as possible. The first FDA-approved biosimilar—Sandoz’s filgrastim biosimilar, Zarxio—entered the market 6 months after receiving regulatory approval but for others the journey to market may take years. Two etanercept biosimilars have FDA approvals but may not reach market until 2029.
The Patent Battle
In an interview with Managed Healthcare Executive®, Simmon said one of her main fights is to see reforms on what patents can cover. “It’s very common for a brand-name biologic manufacturer to obtain as many patents as possible,” she said. Patents may cover a variety of aspects beyond the biologic drug itself including specific language on product labels.
Those patents enable originator manufacturers to block biosimilar manufacturers with lengthy and expensive court battles or settlements that include biosimilar manufacturers agreeing to delay the launch or regulatory filing for its biosimilar, she said.
In the case of AbbVie and adalimumab (Humira), a reference product, patent protections have delayed market entry until 2023 for 6 FDA-approved biosimilar competitors. AbbVie has 136 patents for Humira, a portfolio of legal protection that is typically referred to as a patent “thicket.”
The Dispute Legal Process
Simmon noted that she would like to preserve the opportunity for pharmaceutical companies to enter into patent settlement agreements as a way to quickly resolve legal disputes. She also wants more patent disputes to enter the inter partes review process before the Patent and Trademark Board within the US Patent and Trademark Office, a quicker way for manufacturers to challenge drug patents.
Increase Patent Transparency
Additionally, Simmon wants to help the FDA to find a better way for biosimilar manufacturers to know which patents they may be challenged on, without the need to hire costly law firms.
She noted that currently, there is no easy way for interested parties to know which patents exist for certain products.
In a previous interview with The Center for Biosimilars®, Simmon said a great solution for this would be for the FDA to list patents in the Purple Book, which is an online directory for biologic products. The Biologic Patent Transparency Act that was initiated by Senator Susan Collins, R-Maine, is designed to require greater disclosure of patents and is a key piece of legislation that Simmon in conjunction with the AAM is working to get passed.