In This Issue:
Enter at Your Own Risk: FDA Draft Guidance Highlights the Uncertainty in the Abbreviated Biosimilar Approval Pathway; McDonnell Boehnen Hulbert & Berghoff LLP to Exhibit at 2012 BIO International Convention in Boston; The Murky Morass of Section 101; Exploring the Dichotomy Between Patent and Antitrust Law; and The Coach Services, Inc. v. Triumph Learning, LLC Case: What it Means for a Trademark to Be “Famous” for Trademark Dilution Purposes.
Excerpt from Enter at Your Own Risk: FDA Draft Guidance Highlights the Uncertainty in the Abbreviated Biosimilar Approval Pathway
By 2015, sales of biosimilars in the United States are expected to reach as high as $2.6 billion. Recognizing this market opportunity, biotech companies of all sizes are devoting significant resources to developing these biologic products, which are novel yet dependent on currently approved biologic drug products (at least in part). Following the passage of the Biologics Price Competition and Innovation Act (BPCIA) on March 23, 2010, an entity seeking to bring a biosimilar product to market now has two pathways to consider for securing Food and Drug Administration (FDA) approval. One pathway allows the biosimilar applicant (BA) to seek FDA approval of the product as a new biologic by filing a biologic license application (BLA) under § 351(a) of the Public Health Service Act (PHSA). Alternatively, the BA can follow the newly enacted abbreviated pathway under PHSA § 351(k), which created a new approval pathway for biologics that the FDA determines are “biosimilar” to a BLA-approved reference product (RP). This second option has been available since the passage of the BPCIA on March 23, 2010, yet the FDA still awaits the filing of the first § 351(k) application (referred to as abbreviated biologic license application – “ABLA”).
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