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Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - August...

Venable LLP on

Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Goodwin

Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Goodwin on

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies: Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

Herbert Smith Freehills Kramer on

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Goodwin

Biosimilar-Related Appeals Pending before the Federal Circuit

Goodwin on

There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more

Goodwin

IPR Updates

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Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more

Patrick Malone & Associates P.C. | DC Injury...

Money’s big for Big Pharma — in settlements, lobbying, and product prices

Patrick Malone & Associates P.C. | DC Injury... on

Even as drug makers are settling or scrambling to resolve disputes with regulators over dubious ways they peddle products, Big Pharma is busting records for its spending to lobby lawmakers on skyrocketing prices, easing...more

Goodwin

Pfizer Files for IPR of Two Biogen Patents Directed to Rituximab

Goodwin on

In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the...more

Patterson Belknap Webb & Tyler LLP

Enbrel Biosimilar in Europe and US

Patterson Belknap Webb & Tyler LLP on

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

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