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IP License Biologics Food and Drug Administration (FDA)

Goodwin

Regulatory and Commercial Updates on Bio-Thera’s BAT2506 (golimumab)

Goodwin on

​​​​​​​On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...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

Morgan Lewis

Taking Advantage of the New Purple Book Patent Requirements for Biologics

Morgan Lewis on

New federal legislation will take effect this year that will require a reference product sponsor to submit to the FDA a list of any patents identified to a biosimilar applicant during the patent dance. The FDA is required to...more

American Conference Institute (ACI)

[Virtual Event] 11th Summit on Biosimilars & Innovator Biologics - September 23rd - 24th, 7:45 am - 5:00 pm ET

This year, the BPCIA turns 10! As we prepare to enter the next decade of this revolutionary law, we cordially invite you to join us for ACI’s 11th Annual Biosimilars & Innovator Biologics Summit, in a fully virtual,...more

American Conference Institute (ACI)

[Webinar] Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus - June 24th,...

Hear from the FDA and the leaders of the biosimilars and innovator biologics industries about the impact of the pandemic on the global IP market and gain practical guidance for what is coming down the pipeline. The novel...more

Herbert Smith Freehills Kramer

CAR T-Cell Therapy Takes Off and Brings on Patent Litigation

CAR T-Cell therapy, a new biologic therapy, is taking off. As companies continue to develop this new and promising therapy, patent litigation inevitably follows.  ...more

Foley & Lardner LLP

Supreme Court Decision Largely Favors Biosimilar Applicants

Foley & Lardner LLP on

The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more

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