- Affirmative Recovery
- American Indian Law and Policy
- Antitrust and Trade Regulation
- Appellate Advocacy and Guidance
- Business Litigation
- Civil Rights and Police Misconduct
- Class Action Litigation
- Commercial/Project Finance and Real Estate
- Corporate Governance and Special Situations
- Corporate Restructuring and Bankruptcy
- Domestic and International Arbitration
- Ediscovery
- Health Care Litigation
- Insurance and Catastrophic Loss
- Intellectual Property and Technology Litigation
- Litigation Support Services
- Mass Tort Attorneys
- Medical Malpractice Attorneys
- Personal Injury Attorneys
- Telecommunications Litigation and Arbitration
- Wealth Planning, Administration, and Disputes
-
January 15, 2021Robins Kaplan Partners Named to IAM Strategy 300 Global Leaders Guide
-
January 12, 20212025 Goals - Our commitment to Inclusion, Diversity, and Equity
-
January 5, 2021Litigator Mark Hallberg Joins Robins Kaplan LLP
-
January 28, 2021COVID-19: The Show Did Not Go On
-
February 9, 2021Smart Phone Privacy and Data Security – How to Assess and Minimize Risk in the Current Reality
-
March 6, 2021With Our Voices 2021 Arc Gala
-
2020Clear Evidence Clarified
-
December 27, 2020Covid-19 Relief Bill Provides Long-Awaited Funding to Small Businesses and Individuals
-
December 17. 2020Covid-19 Divorce and Marital Property Agreements
-
January 20, 2021Financial Daily Dose 1.20.2021 | Top Story: Netflix Hits 200M Subscribers, Halts Massive Borrowing
-
January 19, 2021Financial Daily Dose 1.19.2021 | Top Story: Fiat Chrysler and PSA Group Finalize Merger to Form Auto Behemoth Stellantis NV
-
January 15, 2021Financial Daily Dose 1.15.2021 | Top Story: As Unemployment Claims Surge, Biden Unveils $1.9T Covid Recovery Proposal
IP: Bring On The Biosimilars
A section of the Affordable Care Act could cost biosimilar manufacturers and reference sponsors significant time and money.
August 14, 2012
Despite all the headlines, there's one aspect of the Supreme Court's decision on the constitutionality of the Affordable Care Act that didn't get much coverage. The court's approval of the entire act means that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) within the law now goes into full effect. BPCIA sets out a regulatory and dispute resolution framework for follow-on biologics or biosimilars inspired by the one the Hatch-Waxman Act uses for small-molecule generics. But, the fundamental differences that exist between biological products (large molecule drugs) and small molecule drugs and the process for approval and dispute resolution under the BPCIA means that reference product sponsors and biosimilar manufacturers will find themselves in uncharted and potentially time-consuming and costly waters.
Reprinted with permission from InsideCounsel.
The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.
Related Professionals
Bryan J. Vogel
Partner
Related Publications
Related News
If you are interested in having us represent you, you should call us so we can determine whether the matter is one for which we are willing or able to accept professional responsibility. We will not make this determination by e-mail communication. The telephone numbers and addresses for our offices are listed on this page. We reserve the right to decline any representation. We may be required to decline representation if it would create a conflict of interest with our other clients.
By accepting these terms, you are confirming that you have read and understood this important notice.