As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The patents-at-issue are directed to formulations and dosing regimens for aflibercept, an anti-VEGF treatment for retinal disorders including age-related…
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA. TYENNE is the first tocilizumab biosimilar approved in the EU. TYENNE received approval for both subcutaneous (prefilled syringe…
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept biosimilar to Biocon). Now, post-trial briefing is complete. The parties submitted their responsive briefs on July 24,…
Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. As we previously reported, the case was expedited, with trial occurring less than a year after Regeneron filed its complaint. The case was originally filed naming…
As we previously reported, in December 2022, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) had completed acquisition of the global biosimilars business of its long-term partner Viatris, Inc. This week Biocon announced that it had “completed the integration of the acquired biosimilars business in over 70 countries in Emerging…
In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market: Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb). With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021. As…
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by Viatris. Biocon Biologics completed the multi-billion dollar acquisition of Viatris’s global biosimilar business in December 2022. The CRL relates…
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…