SCD411 (aflibercept biosimilar) / Sam Chun Dang Pharm, Apotex - LARVOL DELTA

Celltrion and Samsung Bioepis halt the launch of Ilia similar in the US…What’s left is Samchundang Pharmaceutical? (FNTIMES) - "Celltrion and Samsung Bioepis are experiencing setbacks in the US launch of their biosimilar (generic drug) for macular degeneration treatment 'Eylea'....According to an industry source on the 10th, the US Federal Circuit Court of Appeals did not accept Celltrion's request to overturn the decision of the first trial court to ban the launch of Eylea's biosimilar on the 5th (local time)....This has made it unlikely for domestic bio companies to settle in the US market with Opuviz for the time being. Opuviz's material patent in the US expires in May of this year, but its formulation patent expires in June 2027....The company plans to apply for product approval for Ilia biosimilar 'SCD411' to the FDA within this year. Samchundang Pharmaceutical believes that SCD411 can be launched locally starting in the second half of next year....Alteogen will enter the US market after 2027."

Biosimilar launch • Age-related Macular Degeneration • Macular Degeneration • Wet Age-related Macular Degeneration

Sam Chun Dang Pharm partners with Fresenius Kabi for Eylea biosimilar commercialization in US, Latin America (Korea Biomedical Review) - "Sam Chun Dang Pharm said it entered a licensing agreement with Germany-based Fresenius Kabi for the global commercialization of its biosimilar SCD411, a biosimilar referencing Regeneron’s Eylea (ingredient: aflibercept), in the U.S. and six nations in Latin America....As a result of the news, Sam Chun Dang Pharm's share reached its upper limits on Monday. As of market close, the company’s shares stood at 153,500 won ($105.68), up 29.97 percent from the previous trading day."

Licensing / partnership • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Comparison of the efficacy and safety of SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration. (PubMed, Sci Rep) - "To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration."

Clinical • Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Samchundang Pharmaceutical signs supply contract for Eylea biosimilar to 9 European countries [Google translation] (HIT News) - "Samchundang Pharmaceutical announced...that it will supply biosimilars of the macular degeneration treatment ‘Eylea’ to nine European countries. The other party to the contract was kept confidential according to the contract. The contract includes exclusive supply and sales rights to 9 European countries (UK, Belgium, etc.) for biosimilars (Vial&PFS), a macular degeneration treatment drug containing 'aflibercept' as the main ingredient. Milestones will be received when certain conditions are met. Additionally, the contract period is 10 years from the date of product sale (automatically renewed every 5 years after 10 years), and 55% of gross sales are received."

Licensing / partnership • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3 | N=576 | Completed | Sponsor: Sam Chun Dang Pharm. Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Sam Chun Dang Pharm licenses out Eylea biosimilar to Canadian company in $15 mil. deal (Korea Biomedical Review) - "Sam Chun Dang Pharmaceutical said...that it signed a $15 million licensing-out agreement to supply its biosimilar referencing Eylea (ingredient:aflibercept), SCD411, to Apotex, a Canadian pharmaceutical company. Eylea, developed by Regeneron and Bayer, treats wet age-related macular degeneration. The contract period runs for 10 years from the sale of the product and will be automatically renewed every two years after 10 years elapses."

Licensing / partnership • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samchundang Pharmaceutical, Eylia biosimilar 'SCD411' confirmed with Ministry of Health Canada in advance for approval application [Google translation] (Pax Economic TV) - "Samcheondang Pharmaceutical...announced on...that the date of the Pre-Submission (pre-application meeting) meeting with the Ministry of Health of Canada (Canada Health) for the application for SCD411 (Eylia biosimilar) has been finalized. Samchundang Pharmaceutical, the Canadian Ministry of Health, and Canadian partners will be attending this meeting. The meeting was held in order to apply for permission as soon as possible after receiving the CSR (Clinical Final Report) of SCD411."

Canadian regulatory • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samchundang Pharmaceutical's 'Eylea' phase 3 efficacy proven [Google translation] (PRESS9) - P3 | N=576 | NCT04480463 | Sponsor: Sam Chun Dang Pharm. Co. Ltd. | "Samchundang Pharmaceutical announced...that it had received the final report of the phase 3 clinical trial of SCD411 (Eylea biosimilar). SCD411 has secured equivalence with Eylea, the original drug, in a global phase 3 clinical trial comparing efficacy (primary evaluation index & secondary evaluation index), safety, tolerability, and immunogenicity....The results of the primary evaluation index data analysis showed -1.6 to 0.9 letters in the US standard and -1.8 to 1.1 letters in the European and Japanese standards. Based on this, Samchundang Pharmaceutical plans to apply for licenses to major countries such as the US, Europe, and Japan, and will supply and sell the product through partners as soon as the licenses are obtained."

P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samchundang Pharm completes Phase 3 of Eylea biosimilar 'SCD411' [Google translation] (Digital Today) - "Samchundang Pharmaceutical announced...that it had been notified by a clinical trial agency (CRO) that the phase 3 clinical trial of 'SCD411', a biosimilar of Eylea, currently under development, had been completed....Samchundang Pharm expects to receive the final report of the SCD411 phase 3 clinical trial in January 2024. As soon as related data is released, we plan to announce it through public announcements or conferences."

P3 data • Trial completion • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3 | N=576 | Active, not recruiting | Sponsor: Sam Chun Dang Pharm. Co. Ltd. | Trial primary completion date: Feb 2022 ➔ Nov 2021 | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2022 ➔ Sep 2022

Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Samchundang Pharm's Eylea biosimilar 'SCD411' clinical trial [Google translation] (Pharm News) - "Samchundang Pharmaceutical announced...that it has received a recommendation from the US FDA's Independent Data Monitoring Committee (IDMC) to proceed with the Phase 3 clinical trial of Eylea biosimilar (SCD411)...is currently undergoing global phase 3 clinical trials in the United States, Europe, Japan, and Korea is in progress."

FDA event • Ophthalmology

Biosimilars blurring boundaries… Orthodox pharmaceutical companies accelerate development [Google translation] (Health Korea News) - "In addition, #Samchundang Pharmaceutical is developing 'SCD411', a biosimilar to 'Eylea' (aflibercept), an ophthalmic disease treatment jointly developed by Regeneron of the US and Bayer of Germany...The company plans to conduct global phase 3 clinical trials in 14 countries around the world, including the United States and Korea."

Clinical • Ophthalmology

Korean drugmakers speed up clinical trials of Eyelea biosimilars (Korea Biomedical Review) - "The product patent of Eyelea, jointly developed by Regeneron Pharmaceuticals and Bayer, will expire in 2024 in East Asia, 2025 in Europe, and 2028 in the U.S...Samsung Bioepis has been conducting global phase 3 clinical trials of SB15 since July 2020...It will conduct the clinical trials in 10 countries, including Korea and the U.S., and complete them by the end of February 2022...ALT-L9. The company plans to develop the drug through its subsidiary Altos Biologics and commercialize the biosimilar in Europe by 2025...Samchundang Pharm has speeded up its phase 3 clinical trials of SCD411. The company targets U.S. and Japanese approval in 2023."

Biosimilar launch • BLA • Japanese regulatory • Patent • Trial completion date • Age-related Macular Degeneration • Diabetic Macular Edema • Ophthalmology

A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3; N=560; Recruiting; Sponsor: Sam Chun Dang Pharm. Co. Ltd.; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2022 ➔ Apr 2022

Clinical • Enrollment open • Trial completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P3; N=560; Not yet recruiting; Sponsor: Sam Chun Dang Pharm. Co. Ltd.

Clinical • New P3 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration