K-similars set out to enter the global market

Dong-A Samsung, Celltrion, etc.

Celltrion nears approval of Xolair-Prolia-Stellara similar

Samsung Bioepis expects to receive approval for its Prolia biosimilar next year

Dong-A ST’s Stelara biosimilar nears commercialization...Sam Chun Dang Pharm completes clinical trial on its Eylea biosimilar

Domestic companies are now ready to launch homegrown biosimilars into the global market next year.

 

According to industry sources on the 28th, Celltrion, Samsung Bioepis, and Dong-A ST have completed Phase III clinical trials of its biosimilars and applied for approval from overseas regulators.

 

The companies have successfully developed biosimilars for their global blockbusters such as Stelara and Prolia and are seeking approval next year.

 

Celltrion expects to receive approval for 3 biosimilars next year Celltrion has the largest biosimilar pipeline among domestic companies.

 

To date, the company has 12 pipelines, with six products on the market that include the COVID-19 drug Regkirona, and four more that completed Phase III trials and are on track for marketing authorizations.

 

Celltrion's products that are expected to be approved next year are its Prolia biosimilar CT-P41, Xolair biosimilar CT-P39, Stellara biosimilar CT-P43, and Eylea biosimilar CT-P42.

 

In Phase III trials, the four candidates demonstrated non-inferiority to their respective original drugs.

 

Based on the global Phase III results of CT-P41 this month, Celltrion filed for marketing authorization of CT-P41 for all of Prolia's U.S.

 

indications.

 

Prolia is an Amgen-developed osteoporosis treatment with multiple indications, including giant cell tumor of bone and bone loss.

 

After the U.S., Celltrion plans to file for approval in other key global markets, including Europe.

 

This month, Celltrion also completed the filing of a marketing authorization application for CT-P39 in Canada.

 

The original CT-P39 product, Xolair, is an antibody biologic developed by Novartis for the treatment of allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic spontaneous urticaria.

 

Xolair is a blockbuster product that generated approximately $5 trillion in global sales last year.

 

Celltrion is also nearing commercialization of its Stelara biosimilar CT-P43.

 

To date, it has filed for approval in the U.S., Europe, South Korea, and Australia.

 

Stelara is an interleukin (IL)-12 and 23 inhibitor developed by Johnson & Johnson’s subsidiary Janssen and is used to treat autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

 

The global Stelara market was valued at approximately $23 trillion last year.

 

Celltrion finalized an agreement with Johnson & Johnson last year that will allow the drug to be sold in the US starting Feb.

 

22 next year.

 

Celltrion also recently completed a Phase III clinical trial for its Eylea biosimilar CT-P42 and recently filed for its marketing authorization in the U.S.

 

and Europe.

 

Ayla is a blockbuster macular degeneration treatment developed by Bayer and Regeneron that generated approximately $12 trillion in global sales last year.

 

With such a diverse pipeline, Celltrion aims to have a portfolio of 22 biosimilars by 2030.

 

Samsung Bioepis nears approval of its Prolia biosimilar next year Samsung Bioepis has successfully commercialized five biosimilars in overseas markets in collaboration with its global marketing partners Biogen and Organon.

 

Its candidate that is closest to approval next year is SB16, a Prolia biosimilar.

 

In a Phase III clinical trial conducted on postmenopausal osteoporosis patients, SB16 demonstrated equivalent efficacy to the original drug in terms of change from baseline in lumbar spine and bone mineral density at 12 months after administration.

 

Also, Samsung Bioepis has completed clinical trials of SB15, its Eylea biosimilar, and is pursuing approval procedures in the U.S.

 

and Europe.

 

Samsung Bioepis conducted a Phase III clinical trial involving 449 patients with wet age-related macular degeneration (nAMD) in 10 countries, including the United States and Korea.

 

In the trial, Samsung Bioepis evaluated patients' best-corrected visual acuity (BCVA) up to 56 weeks of treatment with SB15 and found comparable BCVA improvements compared to the original drug.

 

Samsung Bioepis plans to accelerate its expansion in the European market by emphasizing that its biosimilar, SB15, is interchangeable with the original drug.

 

In addition, in May last year, Samsung Bioepis obtained domestic marketing authorization for Lucentis' biosimilar Amelivu, which was approved in the U.S.

 

and Europe in the second half of 2021.

 

Lucentis, a macular degeneration treatment developed by Novartis, is a blockbuster drug that generated global sales of around KRW 4 trillion in 2020.

 

Dong-A ST and Sam Chung Dang Pharm enters the biosimilar competition…submits an application to regulatory authorities Dong-A ST’s Stellara biosimilar DBM-3115 is expected to be approved in Europe next year.

 

The company completed submitting its application to the European Medicines Agency (EMA) in June after demonstrating therapeutic equivalence between its DBM-3115 and Stellara in a global Phase III trial.

 

The company is also preparing for U.S.

 

approval next year.

 

Last month, Sam Chun Dang Pharmaceutical applied for domestic approval for both vials and prefilled syringe formulations of its Eylea biosimilar candidate SCD411.

 

Sam Chun Dang is also preparing for its approval in the United States and Europe.

 

The application was made based on the results of the global Phase III clinical trial on SCD411.

 

In a clinical trial involving 576 patients with macular degeneration, SCD411 demonstrated equivalence to Eylea.

 

In addition, Huon's Global subsidiary, Huons Lab, is also accelerating the development of its Prolia biosimilar, HLB3-013.

 

In February, the company announced that it had confirmed equivalence in nonclinical animal efficacy studies compared to the original product.