Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)), with Takeda’s Entyvio® (vedolizumab).

This follows Intas’ August 2024 CDSCO approval to conduct a Phase 3 clinical study of INTP53 in patients with moderate to severely active ulcerative colitis.

Intas is not the only company to have a vedolizumab biosimilar in development.  For example, in September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024.  Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.

In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis.  Alvotech expects a February 2025 US launch for Selarsdi®.

A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab).  There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.

On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

In August 2024, Intas Pharmaceutical received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase 3 clinical study of its vedolizumab biosimilar, INTP53.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerative colitis in September 2023, and more recently (in April 2024) has received FDA approval for subcutaneous administration of Entyvio®.

On 23 August 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its July 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Hyrimoz® (adalimumab) for the same indications as the currently PBS-listed reference biologic, Abbvie’s Humira®, and other brands of adalimumab.

In addition, the following originator biopharmaceuticals were recommended for PBS listing:

• Roche’s Vabysmo® (faricimab) for the treatment of retinal vein occlusion.
• AstraZeneca’s Lynparza® (olaparib) for the treatment of HER2-negative metastatic breast cancer for patients with a confirmed BRCA1 or BRCA2 mutation.
• Takeda’s Entyvio® (vedolizumab) for continuing treatment of chronic pouchitis.

PBAC reports that MSD’s Keytruda® (pembrolizumab) solution concentrate for IV infusion 100 mg in 4 mL has had its May 2022 recommendation extended for an additional 12 months.  Janssen’s Stelara® (ustekinumab) injection 90 mg in 1 mL pre-filled syringe has had its July 2022 recommendation rescinded.

In August 2024, we reported that a number of biopharmaceuticals and biosimilars are potentially in line for September listings on the PBS, including two biosimilars to Abbvie’s Humira® (adalimumab): Organon’s Hadlima® (adalimumab-bwwd) in 40 mg/0.4 ml PFP and Celltrion’s Yuflyma® (adalimumab-aaty) in 0.8 mg/0.8 ml PFN and PFS.

India’s Medical Dialogues reports that Intas Pharmaceuticals has received the Central Drug Standard Control Organisation’s (CDSCO) approval to conduct a Phase III clinical study to compare the efficacy, safety, immunogenicity and pharmacokinetics of its proposed vedolizumab biosimilar, INTP53, for induction and maintenance therapy in patients with moderate to severely active ulcerative colitis.

Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerative colitis in September 2023, and more recently (in April 2024) has received FDA approval for subcutaneous administration of Entyvio® (vedolizumab).

On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).

This follows the FDA’s acceptance of Takeda’s BLA for ENTYVIO® for the same indication, and the FDA’s approval of ENTYVIO® for ulcerative colitis (UC), in September 2023.

Vedolizumab biosimilars have previously been reported to be in development by Polpharma Biologics, Alvotech(under an agreement with Advanz) and Bio-Thera.

On 3 April 2024, Australia’s PBAC published the July 2024 Meeting Agenda.  On the list of drugs seeking to be PBS reimbursed is Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab).  Hyrimoz® is currently PBS-listed in a 40mg/0.8mL form and reimbursement is now being sought for 20mg/0.2mL, 40mg/0.4ml and 80mg/0.8ml forms.

Sandoz launched its high concentration formulation of Hyrimoz® in Europe in November 2023 and in the US in July 2023.

Also on the PBAC July Agenda are applications for new PBS-listings of:

• Eisai’s Leqembi® (lecanemab) for the treatment of early Alzheimer’s disease and Pfizer’s multiple myeloma treatment Elrexfio® (elranatamab), which are each yet to be TGA-approved; and
• Sanofi’s Beyfortux® (nirsevimab) for the prevention of respiratory syncytial virus in babies, approved by the TGA in November 2023.

Roche has applied to PBS-list a new indication (retinal vein occlusion) and new PFS form of its Vabysmo® (faricimab).

BMS is seeking to vary the existing listings for nivolumab and ipilimumab, and Takeda is seeking authority script listing for vedolizumab for continuing treatment of chronic pouchitis.

The reimbursement of Novo Nordisk’s PBS listed Ozempic® (semaglutide) (and other GLP-1 analogues) for the treatment of type 2 diabetes mellitus will also be considered.

On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn’s & Colitis 360.  The study involved 108 patients switched from IV to a subcutaneous vedolizumab.  The results of the study suggested that switching from an intravenous to a subcutaneous treatment of vedolizumab is convenient and safe. 

On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab).  The results came from a double blinded, randomised, single dose study which assessed PB016’s PK/PD and immunogenicity in 120 subjects, and demonstrated that PB016 has comparable PK/PD and immunogenicity to Entyvio®. 

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.

On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.  Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.