Patent Law Weblog
recent posts
- Why the Alice Test is Stupid, Part IV: The Usefulness Paradox
- Teva Capitulates to Federal Trade Commission Coercion
- USPTO Issues Memoranda on Subject Matter Eligibility
- USPTO Revokes Guidance on AI-Assisted Inventorship, But Rules Remain Basically the Same
- Why the Alice Test is Stupid, Part III: Eligible Independent Claims Can Have Ineligible Dependent Claims
about
Category: Biosimilars
-
By Kevin E. Noonan – After taking most of a decade to approve its first interchangeable biosimilar (Semglee (insulin glargine-yfgn), the U.S. Food and Drug Administration has approved three interchangeable biosimilars since the beginning of this year. The first of these is simlandi (adalimumab-ryvk), approved on February 24th, made by Alvotech and Teva Pharmaceuticals, and interchangeable with…
-
By Kevin E. Noonan – On October 3, 2023, the U.S. Food and Drug Administration (FDA) announced approval of Biogen's Byooviz (ranibizumab-nuna) as an interchangeable biosimilar to Genentech's Lucentis (ranibizumab injection). The drug was approved for intravitreal injection for the following indications: • Neovascular (Wet) Age-Related Macular Degeneration (AMD),• Macular Edema Following Retinal Vein Occlusion (RVO), and•…
-
By Kevin E. Noonan – Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab). The drug was approved for multiple inflammatory disorders: Adult patients with: • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;• active psoriatic arthritis;•…
-
By Kevin E. Noonan – On September 29, the U.S. Food and Drug Administration announced approval of Biogen's Tofidence® (tocilizumab-bavi) as a biosimilar to Genentech's Actemra®, a drug approved for treating COVID-19, rheumatoid arthritis, giant cell arteritis, scleroderma, polyarticular or systemic juvenile idiopathic arthritis, and severe cytokine release syndrome. Tofidence® is the first Actemra biosimilar, and was approved as an intravenous…
-
By Kevin E. Noonan – It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs. See "Trump Administration Considering Reduction in Biologics Exclusivity Period"; "A Solution in Search of a Problem"; "FDA Issues Plan for Further…
-
By Kevin E. Noonan – Henrik Ibsen's 1882 play, An Enemy of the People, engendered an aphorism having a longer lifetime than the play itself (except amongst the literati) which is unfortunate, because the play has some lessons about human nature that arise frequently, particularly in politics. The play begins in an idyllic (albeit chilly) Norwegian town…
-
By Kevin E. Noonan – On November 18th, the U.S. Food and Drug Administration (FDA) announced its approval of Eli Lilly's Rezvoglar (insulin glargine-aglr) product as an interchangeable biosimilar to Sanofi's Lantus (insulin glargine). Both the reference product and the interchangeable biosimilar are "long-acting human insulin analog[s] indicated to improve glycemic control in adults and pediatric patients…
-
By Kevin E. Noonan – It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs (see "Trump Administration Considering Reduction in Biologics Exclusivity Period; A Solution in Search of a Problem"; "FDA Issues Plan for Further Facilitating…
-
By Kevin E. Noonan – On August 2nd, Coherus Biosciences announced FDA approval for its Cimerli™ (ranibizumab-eqrn) product, as an interchangeable biosimilar to Genentech/Roche's Lucentis® (ranibizumab). This biologic drug is a vascular endothelial growth factor (VEGF) inhibitor having five approved indications for Lucentis: the retinal diseases age-related macular degeneration, retinal vein occlusion, diabetic macular edema, diabetic retinopathy,…
-
By Kevin E. Noonan — On Wednesday, the U.S. Food and Drug Administration announced approval to Mylan Pharmaceuticals for a generic form of Allergan's RESTASIS® (Cyclosporine Ophthalmic Emulsion 0.05%) product for treatment of chronic dry eye. RESTASIS® is "a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to…
Patent Docs 