South Korea gets biosimilar of Enbrel

[Fred]

Good news for South Korea after Merck (known as MSD outside the United States and Canada), and Samsung Bioepis announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea.

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Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. BRENZYS is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older).

The approval of BRENZYS in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch BRENZYS in South Korea by the end of this year or early next year.

“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of BRENZYS in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our collaboration with Merck.”

“The approval of BRENZYS in Korea is a key milestone in Merck’s longstanding commitment to improving access to important medicines,” said Dora Bibila, general manager, Merck Biosimilars. “We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of BRENZYS – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis.”

Merck’s launch of BRENZYS will include comprehensive education and support services for healthcare professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.

The approval of BRENZYS in Korea was supported by rigorous analytical structural and functional testing, as well as a Phase 1 crossover pharmacokinetics study and a Phase 3 clinical study comparing BRENZYS to the originator medicine.

Source: merck.com

[jiml]

Good news for South Korea after Merck (known as MSD outside the United States and Canada), and Samsung Bioepis announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea.

Quote:

---

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd. today announced the approval of BRENZYS™ (etanercept), a biosimilar of the immunology medicine Enbrel, by the Ministry of Food and Drug Safety (MFDS) in Korea. BRENZYS is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis) and psoriasis in adult patients (age 18 years and older).

The approval of BRENZYS in Korea represents the first product approval under Merck’s collaboration with Samsung Bioepis, which is designed to offer high-quality biosimilar alternatives to existing biologic medicines to help address patient and healthcare system needs worldwide. Merck plans to launch BRENZYS in South Korea by the end of this year or early next year.

“We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of BRENZYS in Korea is especially gratifying, and underscores our commitment to advancing healthcare through innovation and groundbreaking technology. We look forward to building on this progress in our collaboration with Merck.”

“The approval of BRENZYS in Korea is a key milestone in Merck’s longstanding commitment to improving access to important medicines,” said Dora Bibila, general manager, Merck Biosimilars. “We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of BRENZYS – by combining Merck’s deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis.”

Merck’s launch of BRENZYS will include comprehensive education and support services for healthcare professionals, patients and their caregivers, including biosimilars education, disease education, and reimbursement and access support.

The approval of BRENZYS in Korea was supported by rigorous analytical structural and functional testing, as well as a Phase 1 crossover pharmacokinetics study and a Phase 3 clinical study comparing BRENZYS to the originator medicine.

Source: merck.com

Brilliant news for all sufferers in South Korea, it's good to see biosimilars  getting approval in Asia. does boisimilar also mean lower prices ? And are they likely to roll it out across Asia ?

[Fred]

Brilliant news for all sufferers in  South Korea, it's good to see biosimilars  getting approval in Asia. does boisimilar also mean lower prices ? And are they likely to roll it out across Asia ?

As far as I know they are usually at a lower price, as for the rest of Asia they would have to apply for approval from each country so it could be a while. But yes it's a start.