Enbrel biosimilar candidate, SB4 accepted for review by European Medicines Agency

[Fred]

Lot's of Biosimilars coming through lately for well known psoriasis treatments, and today Samsung Bioepis announced that their Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA)

Quote:

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Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA).

In Europe, Enbrel is indicated for the treatment of a number of rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If authorized by the EMA, SB4 could be available for use in all of the same indications as Enbrel.

"This MAA validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars. More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe" said Christopher Hansung Ko, chief executive officer of Samsung Bioepis.

If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec. It will also be produced at the company’s manufacturing facility in Hillerød, Denmark which is one of the largest biologic manufacturing facilities in the world.

In addition to the European filings, Samsung Bioepis intends to move forward with additional applications for regulatory approvals in other territories worldwide.

About the SB4
Samsung Bioepis previously conducted SB4 Phase 1 and Phase 3 clinical studies. The MAA for the etanercept biosimilar was based on data from a Phase 3, controlled, randomized, multicenter study in Europe where SB4 demonstrated its comparability to Enbrel®. The primary and secondary endpoints of the study were assessed and met the qualification standard for the MAA submission. Full data from the study will be available later this year.

Source: samsungbioepis.com

Enbrel (etanercept)

[jiml]

Nice to see biosimilars coming online although I doubt it will reduce the cost significantly immediately. But let's hope as Enbrel start to lose market share it may start a price war .... Well you never know

[Caroline]

Nice to see biosimilars coming online although I doubt it will reduce the cost significantly immediately. But let's hope as Enbrel start to lose market share it may start a price war .... Well you never know

No... that will not happen.
They, the Pharma's, know and speak to each other.
Unfortunately.  

To Illustrate: Big Pharma 'overcharging' poor countries for child vaccines - report [web]https://rt.com/usa/224835-pharma-vaccine-expensive-poor/[/web]