“With [the] Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern.
Presumably it will be full speed ahead through the regulatory process, and we will see biosimilar applications for approval and attendant patent litigation before too long.” (Dechert LLP)
That giant wooshing you heard yesterday? Not, as it turns out, just the sound of CNN and Fox News changing slides mid-broadcast. Apparently it was also an enormous sigh of relief by biosimilar developers who, like many, had a tremendous amount riding on the Supreme Court’s historic PPACA decision.
From law firm McDonnell Boehnen Hulbert & Berghoff LLP:
“Receiving far less mainstream news coverage is the ruling’s effect on the Biologics Price Competition and Innovation Act (BPCIA), a part of the PPACA which created a new approval pathway in the U.S. for biosimilar products. As a less controversial provision, the BPCIA was barely acknowledged during oral argument, and none of the Justices today expressed any opinions regarding biologic drugs. Nonetheless, if the Supreme Court would have overturned the entire PPACA, the biosimilars legislation would have gone with it. Biosimilar producers can now move forward with their products without fear of legislative overhaul and disruption of their approval progress. The survival of the BPCIA is welcome news for biologics consumers as well, who hope to see lower prices in the near future on these important drugs.” (MBHB)
Background from Morrison & Foerster LLP“The BPCIA permits manufacturers of these follow-on versions to rely on previously disclosed pre-clinical and clinical trial data for the safety and efficacy of the biologic products, so long as the sponsor demonstrates that it (i) is ‘biosimilar’ to a reference product, (ii) uses the same mechanism of action as the reference product, and (iii) is being proposed for previously approved condition(s) of use… The BPCIA also provides a complex framework for resolving patent disputes between sponsors of a biosimilar product and the reference biologic product and resolved long-running disputes by specifying exclusivity periods for reference and certain follow-on biologics.” (MoFo)
Read the updates, including earlier advisories on BPCIA developments:
- Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars – MBHB
- Pathway for Follow-on Biologics Survives the Supreme Court – Morrison & Foerster LLP
- Biosimilar Developers Can Breathe a Sigh of Relief – Dechert LLP
- U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat’l. Fed’n. of Independent Business v. Sebelius – MBHB
- Enter at Your Own Risk: FDA Draft Guidance Highlights the Uncertainty in the Abbreviated Biosimilar Approval Pathway – MBHB
- FDA Publishes Proposed Implementation Guidelines for Biosimilar Approvals - (Feb 2012) Wilson Sonsini
- Path for Generic Competition Open in Biotechnology Industry – Duane Morris LLP