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Biosimilars Safe Harbors BPCIA

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Goodwin

Hospira Asks Federal Circuit to Take Fresh Look at Safe Harbor Ruling in Epoetin Biosimilar Dispute

Goodwin on

Last month, a three-judge panel of the Federal Circuit affirmed a Delaware district court’s judgment of infringement against Hospira and $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s...more

Polsinelli

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute

Polsinelli on

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more

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