Samsung Bioepis Acquires European Approval For Lucentis Biosimilar (SB11)

Approval of the first Lucentis biosimilar ‘Baiwoobiz’ in the European market

Samsung Bioepis (CEO Han-seung Koh) has been approved by the European Commission (EC: European Commission) for ‘Baiwoobiz’, the Lucentis biosimilar. BYOOVIZ TM , project name SB11, ingredient name ranibizumab)' was finally acquired in Europe.

This came two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on June 24th. Samsung Bioepis became the first company in the European market to receive approval for the sale of a Lucentis biosimilar.

Lucerne teeth Roche (Roche) and Novartis (Novartis) is macular degeneration with which sell ophthalmic disease treatment St. ¹⁾ , which has indications such as macular diabetic servants about 4 trillion won was based on global revenues in 2020 2) it amounts to.

An official from Samsung Bioepis said, "We are delighted to be the first Lucentis biosimilar to be approved in the European market, and we will continue to work hard to secure a product portfolio in various treatment fields for patients around the world."

Meanwhile, Samsung Bioepis has a total of 10 blockbuster biosimilar products and pipelines, and 3 types of autoimmune disease treatment (SB2: Remicade biosimilar, SB4: Enbrel biosimilar, SB5: Humira biosimilar) A similar product) and two anticancer drugs (SB3: Herceptin biosimilar, SB8: Avastin biosimilar) are on sale in Europe.

1) Macular Degeneration: A disease in which vision is impaired due to aging and inflammation of the macula, which is the nerve tissue in the center of the retina inside the eye. An ophthalmic disease in which the macula, the part of the retina that receives light most clearly and accurately, loses its function, reduces vision, and in severe cases, blindness. 

Macular degeneration is divided into dry and wet. In the case of dry macular degeneration, it is rare that visual acuity deteriorates to the point of clear blindness. However, in the case of wet macular degeneration, which is called exudative in medical terms (Exudative, the property of blood components seeping out of blood vessels due to inflammation), it can cause a variety of symptoms, such as a sudden decrease in vision, curved objects, and places where the center of the object cannot be seen. has exist.

^* Exchange rate: Woori Bank's announced trading standard rate as of the end of 2020 (1 CHF = KRW 1,234.39)

Woori Bank Announced Trading Standard Rate (1 USD = KRW 1,087.00) as of the end of 2020

Woori Bank Foreign Exchange Center https://spot.wooribank.com/pot/Dream?withyou=FXXRT0011 [Reference] Original drug ( Lucentis) overview

• Ingredient name: Ranibizumab
• Development/Vendor: Roche, Novartis
• Patent Expiration: Europe (2022.7)^*/US (2020.6)
• Treatment indications: neovascular age-related macular degeneration (wAMD), diabetic macular edema (DME), etc.

[Reference] Major development schedule for Samsung Bioepis Lucentis biosimilar

Phase 3 clinical trial ended in December 2019 ¹⁾

In October 2020, the European Medicines Agency (EMA) started reviewing the Application for Authorization (MAA) ²⁾

In November 2020, the US Food and Drug Administration (FDA) started reviewing the application for approval (BLA) ³⁾
Obtained a positive opinion from the European Drug User Advisory Committee (CHMP) in June 2021 - European Commission (EC) in August 2021 Get permission.

1) For clinical schedule, refer to ‘Study Completion Date’ on the global clinical trial information site (clinicaltrials.gov)

2) MAA: Marketing Authorization Application

3) BLA: Biologics License Application