BioBlast w/e 07 Oct 23

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results  for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Novartis announced that the FDA has approved its new intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

On 1 June 2023, Novartis announced that the European Commission approved Cosentyx® for a new indication to treat active moderate to severe hidradenitis suppurativa in adult patients who have had an inadequate response to conventional systemic HS therapy.

Pfizer announced that the FDA has designated Abrilada® as the second interchangeable biosimilar to AbbVie’s Humira® (adalimumab), Following BI’s Cyltezo®.  The designation applies to all approved Abrilada® indications.  Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was the first approved interchangeable adalimumab biosimilar on 15 October 2021.

The FDA accepted Pfizer’s sBLA for interchangeability for its adalimimab biosimilar Abrilada® on 25 February 2022, with a BsUFA goal date in Q4 2022.

Celltrion USA announced that large Medical Benefits Manager Ventegra, will add Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) to its formulary as a “preferred drug” by ‘the first part of October 2023’.

On 2 October 2023, Celltrion announced that it received FDA approval for two additional dosages of Yuflyma®.

Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

On 4 October 2023, Coherus announced its sales of Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis® surpassed 100,000 doses in its first year.

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® for all approved indications.

On 5 October 2023, Coherus resubmitted its BLA to the FDA for Udenyca® OnBody™, biosimilar to Amgen’s Neulasta® after receiving CRL.

Novartis announced it successfully completed the spin-off of Sandoz, its former generics and biosimilars business on 4 October 2023.  Sandoz also made its own announcement about the spin-off, noting it completed its first trading day on the Swiss Exchange on 4 October with an opening share price of CHF 24.00.

The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 and secured shareholder approval for the spin-off at the Novartis EGM on September 15 2023.

Alvotech announced it has partnered with Kashiv Biosciences for an exclusive licensing agreement concerning AVT23 (ADL018), a proposed biosimilar to Novartis/Genentech’s Xolair®, extending across 27 EU countries, the UK, Australia, Canada, and New Zealand.  Alvotech will receive exclusive commercialization rights, and Kashiv will oversee development and manufacturing.

On 2 October 2023, Kashiv announced it had enrolled its first patient in a phase III study for ADL018.

Kashiv Biosciences announced that it has enrolled its first patient in a phase III clinical study of ADL018, its biosimilar to Novartis/Genentech’s Xolair® (omalizumab).  The objective of the study is to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamine treatment (NCT05774639).

On 30 June 2023, Kashiv completed a Phase I clinical trial for ADL-018.

FDA has approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

The Celltrion 80mg adalimumab auto-injector and pre-filled syringe were approved by Healthcare Canada on 30 August 2023.

Boehringer Ingelheim announced that its unbranded interchangeable biosimilar to AbbVie’s Humira®, is now available at a low wholesale acquisition cost, at a 81% discount to Humira®.  It is also available under the brand name Cyltezo® priced at a 5% discount to Humira®.

Cyltezo® was licensed for supply in the US on 1 July 2023 pursuant to the Boehringer and AbbVie settlement of the ongoing patent dispute on 15 May 2019.

Viatris announced it has received an offer for divestiture of most of its Over-the-Counter (OTC) business from Cooper Consumer Health, and has entered into agreements to divest its Women’s Healthcare business (oral and injectable contraceptives) to Insud Pharma, women’s healthcare products Duphaston® and Femoston® to Theramex, and its Active Pharmaceutical Ingredients business to Iquest Enterprises.  It has also agreed to divest commercialisation rights in particular non-core markets that were previously acquired.

On 6 September 2023, Biocon completed its integration of Viatris in North America.  The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

ProciseDx announced that its Procise ADL and Procise IFX therapeutic drug monitoring tests for adalimumab (AbbVie’s Humira® and Amgen’s biosimilar Amgevita®) and infliximab (Janssen’s Remicade® and biosimilars Inflectra® (Pfizer) and Renflexis® (Organon)) have received FDA marketing authorization. The tests quantify levels of adalimumab or infliximab in patients with inflammatory bowel disease (IBD) based on time-resolved fluorescence resonance energy transfer immunoassays using the ProciseDx Analyzer and Lumiphore chemistry.