Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to develop and commercialize a subcutaneous version of a Sandoz biosimilar product. Sandoz also has an option to license the Hybrozyme™…
On November 16, FDA approved Eli Lilly’s REZVOGLAR (insulin glargine-aglr) as the second interchangeable biosimilar to LANTUS (insulin glargine), joining SEMGLEE (insulin glargine-yfgn), which was previously approved as interchangeable to LANTUS. Regarding REZVOGLAR’s approval as interchangeable, FDA stated: “This approval furthers FDA’s longstanding commitment to support a competitive marketplace for…
Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to the agreement, Yoshindo gets exclusive commercialization rights for the biosimilars in Japan, with an estimated market opportunity of $700…
Apotex Inc. recently filed an IPR petition, IPR2022-01524, seeking cancellation of claims 1-14 and 26-30 of U.S. Patent No. 11,253,572 assigned to Regeneron Pharmaceuticals, Inc. The challenged claims generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen of aflibercept, achieving specific visual acuity results from…
In May 2022, Xbrane announced that it had withdrawn its biologics license application (BLA) for its ranibizumab biosimilar of LUCENTIS®. On July 4, 2022, Xbrane announced that based on comments and recommendations in a General Advice letter received from FDA, “Xbrane plans to resubmit the [ranibizumab] BLA during 2022,” and that…
On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). At the meeting, FDA will…
The U.S. Attorney’s Office for the Northern District of California has announced that Racho Jordanov, a co-founder and former Chief Executive Officer of JHL Biotech, and Rose Lin, a co-founder and former Chief Operating Officer of JHL, plead guilty to conspiracy to commit theft of trade secrets and wire fraud, and…
On February 4, 2022, Nova Scotia announced that as part of the Nova Scotia biosimilar initiative, Nova Scotians enrolled in Pharmacare programs will have 12 months (until February 3, 2023) to work with their healthcare providers to switch from originator biologics to the biosimilar version of their drug. Where patients…
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021, AbbVie filed a Second Amended Complaint. On December 29, Alvotech filed a Renewed Motion to Dismiss…
Earlier this year, AbbVie Inc. and AbbVie Biotechnology Ltd. filed a Complaint against Alvotech hf. in the US District Court for the Northern District of Illinois alleging theft of trade secrets relating to adalimumab. In October, AbbVie’s complaint was dismissed for lack of personal jurisdiction. AbbVie has appealed that ruling. In addition…