News & Analysis as of

Drug Pricing Biologics BPCIA

Kramer Levin Naftalis & Frankel LLP

Less Is More — the Premise of the Biosimilar ‘Patent Thicket’ Bill

As part of a push to increase competition and lower drug prices, the U.S. Senate recently passed a bill that limits the number of patents that can be asserted in biosimilar litigation. The Affordable Prescriptions for...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline (Updated)

FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab). FDA has approved only two biosimilars in 2021 after only approving three in 2020. EMA approves four more Avastin® (bevacizumab) biosimilars,...more

Foley & Lardner LLP

The PRICED Act Would Expedite Biosimilar Market Entry

Foley & Lardner LLP on

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

McDonnell Boehnen Hulbert & Berghoff LLP

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

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