Insights+ Key Biosimilars Events of May 2024

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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  
During May, Teva & Alvotech launched Simlandi injection Treat Multiple Indications. Our team at PharmaShots has summarized 12 key events of the biosimilar space of May 2024

1. The US FDA Approves High Concentration of Boehringer Ingelheim's Cyltezo (Biosimilar, Humira)

Date: May 01, 2024

Product:  Cyltezo

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Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023
The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration formulations of Cyltezo (adalimumab-adbm)
Additionally, Cyltezo was approved in Oct 2021 based on the safety & efficacy results incl. from the P-III (VOLTAIRE-X) study investigating the effects of multiple switches between Humira and Cyltezo vs continuous treatment with Humira

2. Lupin and Sandoz Launch Rymti (Biosimilar, Enbrel) in Canada to Treat Plaque Psoriasis

Date: May 03, 2024

Product: Rymti

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Followed by HC’s approval in Aug 2022, Lupin with its partner Sandoz launched Rymti (biosimilar, Enbrel) in Canada
The study showed that Rymti has equivalent safety and efficacy to Enbrel. It is a solution for injection in the form of a pre-filled pen & pre-filled syringe
Rymti is intended to treat children and adolescents with moderate to severe active RA, juvenile idiopathic arthritis, active and progressive Pso arthritis, severe axial spondyloarthritis, moderate to severe plaque Pso, and chronic severe plaque Pso

3. Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US

Date: May 10, 2024

Product:  Xlucane

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Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US
As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of LUCAMZI (Xlucane)
Valorum will make a payment of $45M as license fee incl. regulatory & sales milestones plus sales-based royalties, to be shared b/w both. Furthermore, as per separate agreement, product will be supplied by Xbrane to Valorum at double-digit mark-up over cost of goods sold (CoGS)

4. Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira)

Date: May 13, 2024

Product:  Cyltezo

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Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US
As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm
Quallent will provide high-concentration (40mg/0.4mL) and low-concentration (40mg/0.8mL) citrate-free adalimumab-adbm in a pre-filled syringe or pen. Furthermore, Quallent's 40mg/0.8mL private-labeled adalimumab-adbm will share Adalimumab-adbm's interchangeability designation

5. Teva and Alvotech Launches Simlandi (Biosimilar, Humira) Injection Across US to Treat Multiple Indications

Date: May 20, 2024

Product:  Simlandi

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The company has launched Simlandi (citrate-free biosimilar, Humira) injection to treat RA, PsA, AS, UC, Plaque Pso, HS, uveitis, juvenile idiopathic arthritis & CD in the US
The US FDA has approved Simlandi (40mg/0.4mL) injection. Both the low & high concentrations dosing strengths are approved and marketed across the US
The approval was based on a series of studies incl. P-I (AVT02-GL-101) trial comparing the PK, safety & tolerability in healthy adults and two P-III (AVT02-GL-301 & AVT02-GL-302) studies comparing the PK, efficacy, safety & immunogenicity of Simlandi vs Humira to treat moderate-to-severe chronic plaque psoriasis

6. Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology

Date: May 21, 2024

Product:  Yesafili

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The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV)
The approval was supported by analytical, nonclinical & clinical data from P-III (INSIGHT) study of Yesafili vs Eylea in diabetic macular edema patients, confirming its similarity in PK, safety, efficacy & immunogenicity
Under settlement agreement with Bayer, launch of biosimilar in Canada is anticipated on Jul 1, 2025. Additionally, it was approved across the EU in Sep 2023 and across the UK in Nov 2023

7. Alvotech Collaborates with Dr. Reddy’s to Commercialize AVT03 (Biosimilar, Prolia & Xgeva)

Date: May 21, 2024

Product:  AVT03

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Alvotech & Dr. Reddy’s have signed a license & supply agreement to commercialize AVT03 under which Alvotech will handle the development & manufacturing activities. Dr. Reddy will get regulatory & commercial rights exclusively in US and semi-exclusively in the EU & UK
Alvotech will receive an upfront, regulatory & commercial milestones as well as sales-based payments
Additionally, in Jan 2024, the company reported top-line data of a PK study assessing safety, PK & tolerability of AVT03 vs Prolia in healthy adults. A confirmatory efficacy & safety study in patients & a PK study of AVT03 vs Xgeva in healthy adults are ongoing

8. Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Date: May 22, 2024

Product: Wyost and Jubbonti

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The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards
The EC’s approval was supported by the clinical evaluations verifying the similarity in safety, effectiveness and quality of biosimilars with their reference drugs
Wyost and Jubbonti consist of denosumab as an active ingredient and a human mAb IgG2 that attaches with RANKL to prevent RANK activation on osteoclasts and their precursors, inhibiting osteoclast formation, function & survival. This reduces bone resorption in both cortical as well as trabecular bone

9. The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Date: May 24, 2024

Product: Omlyclo

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Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)
The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK profile of Omlyclo vs Xolair among CSU patients for up to wk.40. Results demonstrated comparable efficacy, safety & immunogenicity
Moreover, Omlyclo is currently under the US FDA’s review after its regulatory submission in Mar 2024

10. Fresenius Reports the US FDA’s BLA Acceptance of FKS518 (Biosimilar, Denosumab)

Date: May 27, 2024

Product: FKS518

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The US FDA has accepted the BLA of the company’s FKS518, a biosimilar product of Prolia (denosumab) and Xgeva (denosumab)
The BLA was supported by the analytical development & similarity evaluation data from two trials comparing FKS518’s pharmacokinetic profile in one while efficacy and safety in another study with the reference
FKS518 is indicated for treating postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, increasing bone mass in high-risk men & women, preventing skeletal-related events in cancer patients, adults and skeletally mature adolescents having giant cell bone tumors and hypercalcemia

11. Bio-Thera Collaborates with STADA for the Commercialization of BAT2506 (Biosimilar, Simponi)

Date: May 28, 2024

Product: BAT2506

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Bio-Thera and STADA have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab)
Under the collaboration, Bio-Thera is entitled to receive a $10M upfront and an additional $147.5M development and commercial milestones upon certain conditions fulfilment
Furthermore, Bio-Thera will handle the development, manufacturing and supply activities of BAT2506, while STADA gains an exclusive right to commercialize it across the EU, UK, Switzerland and other selected regions

12. Amgen’s Bkemv (Biosimilar, Soliris) Receives the US FDA’s Approval for PNH & aHUS

Date: May 28, 2024

Product: Bkemv

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The US FDA has approved Bkemv (eculizuamb-aeeb), biosimilar to AstraZeneca’s Soliris (eculizumab), for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
The approval was based on the study demonstrating similar efficacy and safety between Bkemv vs Soliris. It will be available only through a restricted program known as the Bkemv Risk Evaluation and Mitigation Strategy (REMS)
Bkemv is C5 protein targeting mAb resulting in complement system inhibition to prevent the breakdown of RBCs in the bloodstream of patients with PNH and aHUS