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Samsung Bioepis Announces Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar in Canada

On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis,…

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Janssen Files BPCIA Complaint Against Amgen Regarding Ustekinumab

On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…

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STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved…

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Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held on Thursday, January 19, 2023. As we have previously reported, President Biden issued an Executive Order…

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Executive Order for Advancing Biotechnology and Biomanufacturing Innovation Signed by President Biden

On September 12, 2022, President Biden signed the Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food…

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Formycon Announces Details for Pembrolizumab Biosimilar

This week Formycon AG (“Formycon”) announced details of its previously undisclosed pipeline project for FYB206, Formycon’s biosimilar of KEYTRUDA (pembrolizumab). KEYTRUDA is approved for the treatment of advanced melanoma, lung and other types of carcinoma. According to the press release, Formycon fully owns the development and commercialization rights for FYB206,…

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European Regulatory Heads Make Biosimilars Interchangeable

On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European Economic Area, issued a Joint Statement confirming that…

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Formycon Announces Comparable Efficacy of Ustekinumab Biosimilar to Reference Product STELARA in Phase III Study

This week Formycon AG (“Formycon”) announced positive preliminary efficacy and safety data from the VESPUCCI Phase III clinical trial for FYB202, Formycon’s biosimilar version of STELARA (ustekinumab). The Phase III study was a multi-center, randomized, double-blinded, comparative study of patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The clinical…

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Adalimumab Clinical Trial Updates

The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis. In July 2022, clinical trial data was published from a real-life retrospective observational study of pediatric (<18 years)…

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