bioLOGICs

Fish's bioLOGICs newsletter presents a strategic look at biological sciences litigation. With the passage of biosimilars legislation in the United States, we hope to offer insightful and education information that will provide a deeper understanding of the law that has evolved in the biological sciences.

Spring 2012 - Life Sciences Update This newsletter will replace our former publication, bioLOGICs, but will continue to include biosimilars content within its broader scope.

Fall 2011 bioLOGICs

Winter 2010 bioLOGICs

Fall 2010 bioLOGICs

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Biosimilars Legislation Summary

The legislation to create a regulatory pathway for biosimilars (i.e., follow-on biologics) significantly changes the economics of their development and marketing. While there are numerous generic small-molecule drugs available, there have been almost no biosimilars available in the United States. This has been a result of the absence of a regulatory pathway for the approval of biosimilars. In contrast, the Hatch-Waxman Amendments created such a pathway for small-molecule drugs (technically, drugs approved under Section 505 of the Food, Drug & Cosmetic Act).



Recent News and Events

May 23, 2012 - Irene E. Hudson (NY) will speak on the panel "Timing is Everything: A Checklist to Ensure Preparedness for Litigation" at ACI's Biosimilars Conference in New York, NY. For more information or to register, click here.

May 22, 2012 - Fish & Richardson is a sponsor of ACI's Biosimilars Conference, May 22-23, 2012 at the New York Marriott East Side in New York, NY. On Wednesday, May 23, Irene E. Hudson (NY) will speak on the panel "Timing is Everything: A Checklist to Ensure Preparedness for Litigation." For more information or to register, click here.

March 30, 2012 - Join Michael Siem and the ABA-IPL Committee 105 for a CLE Panel at the upcoming ABA-IPL Spring Conference entitled: Follow-on Biologics: Where Are We Now and Where Are We Headed? This program will provide an overview of the implementation of the Biosimilars Act as well as address the possible impact of the reduction of the exclusivity period, as proposed by President Obama in the 2012 Budget. The program will take place Friday, March 30, 2012, 3:30-5:00pm. For more information, click here.

February 9, 2012 - The Food and Drug Administration (FDA) issued three draft guidance documents regarding the scientific and quality considerations for the development and approval of biosimilar products.

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

The FDA intends that these initial guidelines will assist sponsors in demonstrating the biosimilarity of a proposed therapeutic protein product to a reference biologic product for the purposes of submitting a 351(k) application to the FDA. Although the development process will necessarily entail consultations with the FDA in optimizing the approval process, it appears that a number of studies will be required to demonstrate biosimilarity in a "stepwise approach." Also, the FDA intends to use a "risk-based totality-of-the-evidence approach" to evaluate all data and information submitted by a sponsor and contemplates that the type and amount of evidence sufficient to demonstrate biosimilarity will be determined on a product-specific basis.

Biologics Price Competition and Innovation Act (BPCIA)

On March 30, 2010, President Obama signed into law a reconciliation bill that finalized Congress's health care reform legislation, the Patient Protection and Affordable Care Act. In addition to the much-discussed provisions regarding health insurance, the Act creates a regulatory pathway for the approval of follow-on biologics (FOBs). The relevant statutory text is subtitled "Biologics Price Competition and Innovation Act" and is available here.



Key features of the Biologics Price Competition and Innovation Act include:

• Twelve years of market exclusivity (with a possible further six months of pediatric exclusivity) for pioneer products during which time FOB applications cannot be approved
• Two standards of FOB approval - biosimilarity and interchangeability - to be implemented by the Secretary of Health and Human Services
• Exclusivity for the first FOB product found to be interchangeable with the pioneer product
• Confidential, choreographed exchanges of highly detailed, substantive disclosures between the FOB applicant and the pioneer regarding the FOB product, pioneer patents and the parties' respective contentions relating to the product and the patents
• Absence of a statutory stay of generic approval during the pendency of patent litigation

Previous Versions of the BPCIA as Passed by the House and Senate

January 14, 2010: President Obama reportedly informed congressional Democrats that he supported a pioneer exclusivity period less than the proposed 12 years and more on the order of 10 years or fewer. Six governors responded to the remarks with this letter.

December 24, 2009: Senate passed H.R. 3590, the Patient Protection and Affordable Care Act. Section of 7002 of this Act, whose subtitle is "The Biologics Price Competition and Innovation Act of 2009," includes provisions that create a licensure pathway for biosimilar biological products. H.R. 3590 proposes 12 years of exclusivity for pioneer biologic products. A copy of the bill is here.

November 7, 2009: House passed H.R. 3692, the Affordable Health Care for America Act. Section 2575 of this Act is heavily based on earlier bills and amendments sponsored by Rep. Anna Eshoo (D-CA) in the House. Under H.R. 3692, the bill proposes 12 years of exclusivity for new biologic products. A copy of the bill is here.

Biologics/Biosimilars Archive: 2010 | 2009 | 2008



Additional Resources

Summary of Biologics Price Competition and Innovation Act (2010) by Terry G. Mahn, Principal, Fish & Richardson