On June 24, 2017, Hogan Lovells attorneys Xin Tao (Washington DC Office) and Liang Xu (Beijing Office) spoke at the 15th Annual Conference of the Sino-American Pharmaceutical Professionals Association – Greater Philadelphia’s annual conference. Mr. Tao presented on the “Biosimilar Exclusivity and Interchangeability: A Legal Primer” for both innovators and biosimilar applicants. Mr. Liang presented
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Supreme Court Issues Landmark Biosimilar Ruling
On June 12, 2017, the Supreme Court issued a unanimous ruling in Sandoz Inc. v. Amgen Inc. The case interprets two provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and is expected to significantly impact the approval and patent litigation processes for biosimilar applications. First, the BPCIA requires a biosimilar applicant…
Guide to Recent Biosimilar Activity by FDA and in the Supreme Court
The US Food and Drug Administration (FDA) recently completed a flurry of activity to help define the biosimilar pathway, including issuing final guidances on biosimilar clinical pharmacology and biologics non-proprietary naming, as well as a draft guidance on biosimilar interchangeability. In parallel, litigation that should clarify the BPCIA patent resolution process, including timing of the…
FDA Denies Three Petitions on Biosimilar Labeling: Refers Petitioners to Guidance Process
The U.S. Food and Drug Administration denied three pending petitions regarding biosimilar labeling without substantively addressing most of the issues raised in the petitions. FDA’s denial letter indicates that biosimilar labeling guidelines are still in flux while FDA works to finalize its March 2016 Draft Guidance for Industry: Labeling for Biosimilar Products. According to FDA,…
AIFA publishes “Second Concept Paper” on biosimilars
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same
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AIFA publishes “Second Concept Paper” on biosimilars
On June 15, 2016, AIFA (the Italian Medicines Agency) published a “Second Concept Paper” on the use of biosimilars within the National Health System (NHS). The document is intended to start a discussion that should eventually lead to an amended or new version of the agency’s Position Paper of 28 March 2013 on the same
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Biosimilar switching: Dutch MoH announces the set-up of a national system for biological medicinal products
The Dutch Minister of Health (MoH) announced the set-up of a national system to trace the safety of biological medicinal products. The MoH expects an increase in the number of biosimilar prescriptions. The national system should contribute to a responsible use of such cheaper alternatives and as such lead to a sustainable Dutch healthcare system. With…
FDA Guidance on Transition Biological Products: Implications for Exclusivity and Patent Listings
FDA issued a draft guidance on March 14, 2016 explaining how the agency proposes to implement the provisions under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for moving protein products currently approved under the drug statute (section 505 of the Food, Drug and Cosmetic Act) to the biologics system (section 351 of…
FDA Announces Policy for Unique Nonproprietary Names for Biologics and Biosimilars
In a Federal Register notice, FDA announced its draft guidance, “Nonproprietary Naming of Biological Products,” in which the agency articulates the need “for biological products licensed under the Public Health Service Act (PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix.” Described in an accompanying proposed rule, the Agency…
AbbVie Challenges FDA Biosimilar Labeling
In a citizen petition, AbbVie has challenged the Food and Drug Administration’s (FDA’s) approach to biosimilar labeling, as implemented in the agency’s recent approval for Zarxio (filgrastim-sndz) as a biosimilar to Neupoen (filgrastim). As we previously blogged, the prescribing information FDA approved for Zarxio seems to follow a “generic drug” model; the Zarxio…