Key Biosimilars Events of January 2025

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 Samsung Bioepis & Teva Partners to Commercialize Epysqli in the US. Our team at PharmaShots has summarized 9 key events of the biosimilar space of January 2025

1. GlycoNex Reports Licensing Agreement to Develop SPD8 (Biosimilar, Prolia and Xgeva)

Company: GlycoNex

Product: SPD8

Active Ingredient: Denosumab

Reference Product: Prolia and Xgeva

Reference Product Company: Amgen

Disease: Osteoporosis

Date: Jan 06, 2025

Shots:

GlycoNex has reported a licensing agreement to develop SPD8, a biosimilar version of Amgen’s Prolia and Xgeva (denosumab)

The licensee will secure rights for the development, regulatory activities & commercialization of SPD8 in the designated regions. The deal includes development and commercial milestones, supporting GlycoNex's global business operations

SPD8 is under P-III clinical evaluation initiated in Dec 2024 after P-I confirmed its safety and PK equivalence for treating osteoporosis and skeletal-related events in patients with bone metastases from solid tumors

2. Fresenius Kabi Canada Receives Health Canada NOC for Otulfi (Biosimilar, Stelara)

Company: Fresenius Kabi Canada

Product: Otulfi

Active Ingredient: Ustekinumab

Reference Product: Stelara

Reference Product Company: Johnson & Johnson

Disease: Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, and Active Psoriatic Arthritis

Date: Jan 08, 2025

Shots:

Following the NOC approval of Tyenne (tocilizumab) & Idacio (adalimumab), Fresenius Kabi Canada has received Health Canada NOC for Otulfi (ustekinumab), a biosimilar to Stelara for Crohn's disease, ulcerative colitis, plaque psoriasis, and active psoriatic arthritis

NOC approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent efficacy, safety, PK & immunogenicity to Stelara in mod. to sev. plaque psoriatic pts

In February 2023, Fresenius Kabi and Formycon formed a global partnership to commercialize ustekinumab biosimilar in key global markets

3. Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US

Company: Samsung Bioepis and Teva

Product: Epysqli

Active Ingredient: Eculizumab-aagh

Reference Product: Soliris

Reference Product Company: Alexion Pharm

Disease: Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome, and Generalized Myasthenia Gravis

Date: Jan 10, 2025

Shots:

Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US

Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar portfolio to 18 assets across multiple therapeutic areas

Epysqli is a complement inhibitor to treat rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in anti-AchR antibody-positive adults

4. Teva Partners with Klinge Biopharma & Formycon to Commercialize FYB203 (Biosimilar: Aflibercept) in EU & Israel

Company: Teva Pharmaceuticals, Klinge Biopharma & Formycon

Product: FYB203

Active Ingredient: Aflibercept

Reference Product: Eylea

Reference Product Company: Bayer

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

Date: Jan 13, 2025

Shots:

Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio

The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a biosimilar of Lucentis (Ranibizumab), in Europe

As per the terms, Klinge will receive milestones & revenue share in exchange for Teva marketing FYB203 as Ahzantive after EC approval (expected in Jan 2025), while Klinge holds its global commercialization rights

5. Formycon and Fresenius Kabi Report the MHRA’s Approval of Otulfi (Biosimilar, Stelara)

Company: Formycon and Fresenius Kabi

Product: Otulfi

Active Ingredient: Ustekinumab

Reference Product: Stelara

Reference Product Company: Johnson & Johnson

Disease: Mod. to Sev. Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, and Active Psoriatic Arthritis

Date: Jan 15, 2025

Shots:

The UK’s MHRA has approved Otulfi (SC & IV), biosimilar of J&J’s Stelara (ustekinumab), to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque psoriasis as well as active psoriatic arthritis & is set to enter UK market as per a confidential settlement b/w the companies and J&J. It is approved across the US, EU & Canada

Approval was granted after the analysis of analytical, preclinical, clinical & manufacturing results that showed equivalent efficacy, safety & PK to Stelara in mod. to sev. plaque psoriatic patients

In addition, Formycon & Fresenius Kabi partnered in Feb 2023 under which the latter secured Otulfi’s commercial rights in the international markets, incl. the UK

6. Biothera and World Medicine Partners to Commercialize BAT2206 (Biosimilar: Ustekinumab) in Turkey

Company: Bio-Thera & World Medicine

Product: BAT2206

Active Ingredient: Ustekinumab

Reference Product: Stelara

Reference Product Company: Johnson & Johnson

Disease: Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, and Active Psoriatic Arthritis

Date: Jan 16, 2025

Shots:

Bio-Thera & World Medicine entered into an exclusive license & commercialization agreement for BAT2206, a biosimilar to Janssen’s Stelara (ustekinumab), leveraging World Medicine’s marketing expertise & distribution network in Turkey

As per the terms, World Medicine will hold market approval of BAT2206 in Turkey as well as its registration, imports, promotion & marketing, while Bio-Thera will handle the commercial supply & manufacturing in its Guangzhou facilities

In addition, Bio-Thera has submitted MAA for BAT2206 to China's NMPA, EMA & the US FDA

7. Formycon Reports the EC’s Approval of FYB203 (Biosimilar, Eylea) Under the Brand Names Ahzantive and Baiama

Company: Formycon & Klinge Biopharma

Product: FYB203

Active Ingredient: Aflibercept

Reference Product: Eylea

Reference Product Company: Bayer

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

Date: Jan 20, 2025

Shots:

Formycon & Klinge Biopharma have reported the EC’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand names: Ahzantive & Baiama valid across the EU plus Iceland, Liechtenstein & Norway after receiving the CHMP’s recommendation in Nov 2024

The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularization (CNV) & Macular Edema following Retinal Vein Occlusion (RVO)

Furthermore, Formycon, Klinge & Teva entered into a licensing & supply agreement for the semi-exclusive commercialization of FYB203 in the EU & Israel in Jan 2025

8. Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Company: Alvotech & Teva

Product: AVT05

Active Ingredient: Golimumab

Reference Product: Simponi & Simponi Aria

Reference Product Company: Johnson & Johnson

Disease: Mod. to Sev. Rheumatoid Arthritis

Date: Jan 27, 2025

Shots:

The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25

Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr 2024 & topline results from a PK study comparing AVT05 & Simponi among healthy adults in Nov 2023

Additionally, Alvotech partnered with Teva in Aug 2020 to market five biosimilars, incl. AVT05, in the US. Later, the partnership expanded to nine products in total

9. Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra)

Company: Celltrion

Product: Avtozma

Active Ingredient: Tocilizumab-anoh

Reference Product: Actemra

Reference Product Company: Genentech

Disease: Mod. to Sev. Rheumatoid Arthritis

Date: Jan 30, 2025

Shots:

The US FDA has approved Avtozma (biosimilar, Actemra) for treating diseases such as RA, GCA, pJIA, sJIA, and COVID-19

Approval was based on P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.24 & with 1-year results with no clinical differences in efficacy, PK, safety, and immunogenicity

Avtozma (SC/IV) is a recombinant humanized mAb that targets the IL-6 receptor. The IV infusion is available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL (20 mg/mL), while SC in 162 mg/0.9 mL single dose prefilled syringe or autoinjector

Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of January 31, 2025, no PR was available: