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….
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,…
Mylan has filed two petitions for inter partes review of Sanofi’s patents related to insulin glargine: IPR2017-01526 on U.S. Patent 7,476,652, and IPR2017-01528 on U.S. Patent 7,713,930. Insulin glargine is marketed under the tradename Lantus®. As we have reported, both the ‘652 and ‘930 patents are the subject of litigation…
The Competition and Markets Authority (CMA) in the United Kingdom announced a provisional decision finding that Merck Sharp & Dohme (MSD) violated competition law with its discount pricing on Remicade. This provisional determination does not indicate that MSD in fact violated competition law. The CMA specifically found that MSD used its position in…
According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently marketed intravenous infliximab product (“CT-P13 IV”) in patients with rheumatoid arthritis. An earlier August 25, 2016 record on ClinicalTrials.gov…
The FDA announced today that the Oncologic Drugs Advisory Committee will hold a public meeting on July 13, 2017 in Silver Springs, Maryland to discuss two biosimilar applications. During the morning session, the committee will discuss Amgen’s application for a proposed biosimilar of Genentech/Roche’s AVASTIN (bevacizumab). During the afternoon session, the…
Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm Kyowa Kirin Biologics Co., Ltd. announced that on May 18, 2017, the EMA accepted its application for FKB327, an adalimumab biosimilar candidate to AbbVie’s HUMIRA…