Key Biosimilars Events of November 2024

Shots:

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

A major highlight was the EC’s approval of Sandoz’ Afqlir for treating Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases. Our team at PharmaShots has summarized 6 key events of the biosimilar space of November 2024

1. Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi)

Active Ingredient: Golimumab

Date: Nov 04, 2024

Product: AVT05

Reference Product: Simponi & Simponi Aria

Company: Alvotech and Advanz Pharma

Disease: Moderate To Severe Rheumatoid Arthritis

Shots:

The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25

Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis, showing similar efficacy, safety & immunogenicity. Earlier, in Nov 2023, it reported positive data from a PK trial among healthy adults which confirmed its tolerability & PK profile

Golimumab is a monoclonal antibody that blocks TNF alpha, a protein involved in chronic inflammatory diseases like rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

2. Samsung Bioepis Report the CHMP’s Positive Opinion of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Active Ingredient: Denosumab

Date: Nov 15, 2024

Product: Obodence & Xbryk

Reference Product: Prolia & Xgeva

Company: Samsung Bioepis

Disease: Osteoporosis

Shots:

The CHMP has granted a positive opinion to Obodence (60mg pre-filled syringe) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva (denosumab), respectively

Opinion was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to infinity & maximum serum concentration

P-III study depicting SB16’s similar efficacy, safety, immunogenicity & PK/PD vs reference in postmenopausal osteoporosis (PMO) patients (n=457). The 1EPs of % change in lumbar spine BMD at mos.12 was met, with sustained comparability up to mos.18, incl. after switching from denosumab to SB16

3. Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD)

Active Ingredient: Aflibercept

Date: Nov 15, 2024

Product: Afqlir

Reference Product: Eylea

Company: Sandoz

Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases

Shots:

The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25

Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine

Aflibercept is a recombinant fusion protein that inhibits abnormal vessel growth by binding with VEGF-A & placental growth factor (PlGF), enhancing visual acuity & inhibiting disease progression

4. Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)

Active Ingredient: Aflibercept

Date: Nov 18, 2024

Product: Opuviz

Reference Product: Eylea

Company: Samsung Bioepis and Biogen

Disease: Wet AMD & Visual impairment from macular edema due to RVO & Myopic CNV

Shots:

The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies

Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP of BCVA improvement at wk.8, and interim analyses at wks.32 and 56 confirming its comparability

Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularization (myopic CNV)

5. Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of Ahzantive/Baiama/FYB203 (Biosimilar, Eylea)

Active Ingredient: Aflibercept

Date: Nov 18, 2024

Product: Ahzantive/Baiama (FYB203)

Reference Product: Eylea

Company: Fresenius Kabi and Formycon

Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Several Other Serious Retinal Diseases

Shots:

The CHMP has recommended FYB203 under the brand names, Ahzantive/Baiama, biosimilar version of Eylea (aflibercept), with the decision anticipated in 2nd half of Jan’25

The approval, if granted, will be valid across the whole EU, as well as in Iceland, Liechtenstein & Norway. It is already approved across the US in Jun 2024

FYB203 (VEGF inhibitor) is indicated for adults with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other retinal disorders such as Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularization (CNV) and Macular Edema following Retinal Vein Occlusion (RVO)

6. Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab)

Active Ingredient: Nivolumab

Date: Nov 19, 2024

Product: N/A

Reference Product: Opdivo

Company: Xbrane Biopharma & Intas Pharmaceuticals

Disease: Oncology

Shots:

Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU

As per the agreement, Intas will fund and manage clinical as well as regulatory development, and lead the commercialization of the nivolumab biosimilar across the globe. The product is expected to launch in the US by Dec 2028 and in the EU after Jun 2030, following patent expirations