The Patient Protection and Affordable Care Act, which included the Biologics Price Competition and Innovation Act of 2009, created a regulatory approval pathway for “biosimilars,” biological products shown to be biosimilar to a licensed reference product. Notably, the Act also established a 12-year market exclusivity period for the licensed reference product, as well as procedures for resolving patent disputes based on a biosimilar application. With the release of FDA draft guidance on February 9, 2012, active discussion on many issues related to execution and operations have surfaced as new regulations and procedures are put into action.
Our Life Sciences Industry Team is committed to working with you as you confront issues related to the Act. Our team comprises experienced biotechnology attorneys in the areas of IP and IP litigation, FDA regulatory, and corporate law, all with an understanding of the complex legal and business issues surrounding biosimilars and how they impact your life sciences enterprise.
Regulatory Strategy and Biosimilars
- What factors affect the decision to pursue an abbreviated biosimilar application rather than a full Biologics License Application (BLA)?
- What are the potential ramifications of the FDA draft guidance issued February 9, 2012?
- What data will be necessary to demonstrate interchangeability between the biosimilar product and the reference product?
- What nomenclature conventions will be adopted by FDA?
- How can applicants demonstrate that there are no meaningful clinical differences in the biosimilar proposed product in terms of safety, purity, and potency?
- When do changes to a BLA affect whether it may be a new product eligible for exclusivity?
- What are the pharmacovigilance requirements for biosimilar products?
IP Issues With Biosimilars
- Strategic management of IP portfolios before and after any exclusivity periods
- Biosimilar versus biobetter: strategic considerations for protection and challenges
- Protecting trade secrets
- Assessing and strategizing regarding the biosimilar patent dispute resolution process
- Preparing for information exchange between a biosimilar applicant and BLA holder
- Assessing patent validity/invalidity and infringement/non-infringement as relevant to a biosimilar patent dispute resolution process, related information exchange, litigation, or settlement
- Pre-litigation and litigation strategies to promote IP and regulatory goals
Corporate Issues With Biosimilars
- Valuation of IP portfolios
- Commercialization strategies
- Considerations for licensing and collaboration agreements, including antitrust issues