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Category: Biosimilars
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By James DeGiulio — On November 23, the European Medicines Agency (EMA) published guidelines for biosimilar monoclonal antibodies (mAb). Earlier this week, we reported on the clinical and non-clinical study portion of the guidelines (see "EMA Publishes Guidelines for Biosimilar Antibodies – Part I"). The EMA released a second set of guidelines along that directly…
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By James DeGiulio — On November 23, the European Medicines Agency (EMA) finally published its guidelines for biosimilar monoclonal antibodies (mAb). The two-part guidelines are now subject to public consultation until May 31, 2011, after which the guidelines are to be finalized. At first glance, it appears that the EMA has relaxed several classic requirements…
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By James DeGiulio — Earlier this month, we reported that a major issue discussed at the Food and Drug Administration's public hearings on the implementation of the Biologics Price Competition and Innovation Act (BPCIA) concerned the standards that the FDA will require for clinical testing of biosimilars (see "Clinical Trial Requirements Are Top Issue at…
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By James DeGiulio — Last week, the Food and Drug Administration began gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"). Several issues came to light during the first day of testimony, and the…
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By Donald Zuhn — Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, the biotech industry has waited to see which company might be the first to take advantage of the new approval pathway. Last week, Pfizer Inc. joined a…
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By James DeGiulio — As the Food and Drug Administration begins gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"), the European Medicines Agency (EMA) announced that it has finalized its requirements for biosimilar…
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By Donald Zuhn — Last week, the congressional daily The Hill reported on a draft notice from the Food and Drug Administration (FDA) that was being circulated among healthcare lobbyists on Capitol Hill. The notice, which the agency has yet to publish in the Federal Register, concerns public hearings and a request for comments on the…
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By Donald Zuhn — Biosimilar Approval Pathway: Who Will Be First? Since President Obama signed the Patient Protection and Affordable Care Act into law in March, thereby establishing an approval pathway for biosimilar biological products, interested obsevers have been wondering whether the regulatory pathway would be utilized, and if so, who might be the first…
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By Donald Zuhn — On Sunday night, the House of Representatives voted by a narrow 219-212 margin to agree to the version of the Patient Protection and Affordable Care Act (H.R. 3590) that the Senate passed on December 24, 2009 (see "Follow-on Biologics News Briefs – No. 11"). Less than an hour later, the…
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By Kevin E. Noonan — Policy arguments based solely on outcome rather than process are rarely effective when put into practice. This is because the desired benefits of the outcome blind the policymaker to the question of whether the desired outcome can be achieved without considering the effects (intended or otherwise) by the process. …
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