Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukemia, and immunological diseases…
On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen. On June 12, the Supreme Court decided Sandoz v. Amgen, which presented the Justices with multiple significant questions about the correct interpretation and application of the biosimilars…
At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin Biologics’ proposed biosimilar, in 730 patients with active rheumatoid arthritis (RA) inadequately controlled on methotrexate. The study concluded…
Today, Boehringer Ingelheim announced the 24-week results from the Phase III VOLTAIRE®-RA study, comparing the adalimumab biosimilar candidate BI 695501 to Abbvie’s Humira® in patients with moderate- to severely-active rheumatoid arthritis. According to BI, the results indicate that BI 695501 has similar efficacy, safety, and immunogenicity as Humira® in these…
Celltrion Healthcare presented new data on their Rituximab biosimilar Truxima® (CT-P10) at the International Conference on Malignant Lymphoma (ICML) in Switzerland and the European League Against Rheumatism (EULAR) Congress 2017 in Spain. According to the presentation, data from a randomized, double-blind, controlled phase III study in 140 patients indicate that Truxima®…
We previously reported that the PTAB upheld the validity of Bristol-Myers Squibb’s ‘239 patent covering their rheumatoid arthritis agent Orencia® (abatacept). Since 2008, Orencia® has only been approved for use in patients 6 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA). However, last…
The PTAB has issued Final Written Decisions in IPRs filed by Coherus against two of Abbvie’s patents, IPR2016-00188 (U.S. Patent No. 9,017,680) and IPR2016-00189 (U.S. Patent No. 9.073,987), finding the challenged claims unpatentable as obvious over the prior art. The patents are directed to methods of treating rheumatoid arthritis using adalimumab….
The U.S. Supreme Court granted Oil States Energy Services’ petition for a writ of certiorari seeking review of the constitutionality of post-grant review proceedings by the USPTO’s PTAB. Oil States appealed to the U.S. Supreme Court after the Federal Circuit decided to uphold the PTAB’s invalidation of claims in a…
We previously reported on the oral argument in Sandoz v. Amgen. Today Justice Thomas delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme Court held that notice of commercial marketing may be given prior to FDA approval, siding with Sandoz and reversing the Federal…
Coherus BioSciences, Inc. announced this morning that the FDA has issued a complete response letter (“CRL”) for its biologics license application for its pegfilgrastim (Neulasta®) biosimilar. According to Coherus, “the CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay,…