Date: 2016-09-12
Type of information: Granting of a Market Authorisation in Canada
Product name: Brenzys™/Benepali™ - SB4 - Enbrel® (etanercept) biosimilar candidate
Compound: etanercept biosimilar
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Action mechanism: biosimilar/TNF alpha inhibitor/fusion protein. Etanercept is a fusion protein, which preferentially binds to TNF-alpha and thereby inhibits the biological activity of TNF-alpha. Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, including Brenzys™/Benepali™, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Biogen and Merck&Co. Samsung Bioepis'pipeline includes 13 biosimilar candidates: SB4 biosimilar candidate referencing Enbrel® (etanercept), SB2 biosimilar candidate referencing Remicade® (infliximab), SB5 biosimilar candidate referencing Humira® (adalimumab), SB9 (MK-1293) biosimilar candidate referencing Lantus® (insulin glargine), SB3 biosimilar candidate referencing Herceptin® (trastuzumab), SB8 biosimilar candidate referencing Avastin® (bevacizumab).
Company: Samsung Bioepis (Republic of Korea) Merck&Co (USA - NJ)
Disease: moderate-to-severe rheumatoid arthritis psoriatic arthritis non-radiographic axial spondyloarthritis plaque psoriasis
Latest news: * On September 12, 2016, Samsung Bioepis announced that Brenzys™ (biosimilar referencing Enbrel® (etanercept), SB4) received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. Brenzys™ will be commercialized in Canada by Merck Canada. Prior to receiving approval in Canada, Samsung Bioepis’ SB4 etanercept biosimilar received regulatory approvals from Korea’s Ministry of Food and Drug Safety (MFDS) as Brenzys™ in September 2015, the European Commission (EC) as Benepali® in January 2016 and Australia’s Therapeutic Goods Administration (TGA) as Brenzys™ in July 2016. The regulatory submission for Brenzys™ was based on data from a randomized, double-blind 52-week Phase III study, involving 596 patients with moderate to severe rheumatoid arthritis across 70 sites in 10 countries, who were treated with either weekly dose of subcutaneous 50 mg SB4 or Enbrel® with background methotrexate. At Week 52, SB4 showed ACR20 response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel® arm, fully supporting the 24-week study results of 78.1% and 80.3%, respectively. * On January 16, 2016, Samsung Bioepis has been granted European Commission approval for Benepali® , an etanercept biosimilar referencing Enbrel®. Benepali® has been granted marketing authorization in the European Union for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make Benepali® available for patients in the coming weeks. Benepali® is the first etanercept biosimilar referencing Enbrel® to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNF’s are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there. The EC approval was based on a preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared Benepali® to its reference product Enbrel.iii, iv The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive Benepali® or Enbrel® in a 1:1 ratio. Analysis of the primary endpoint showed that Benepali® had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1% in the Benepali® arm versus 80.3% in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8% in the Benepali® arm versus 81.5% in the Enbrel® arm. The safety profile of Benepali® was comparable to that of Enbrel® throughout the study. * On November 19, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Benepali™, intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. The applicant for this medicinal product is Samsung Bioepis UK. Benepali™ will be available as a 50 mg solution for injection. This biological medicinal product is similar to the reference product Enbrel® (etanercept), which was authorised in the EU on 3 February 2000. * On September 8, 2015, Merck & Co 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. 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 & Co plans to launch Brenzys™ in South Korea by the end of this year or early next year. * On January 21, 2015, Samsung Bioepis 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®. 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. 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2016-01-16
Favourable opinion UE: 2015-11-19
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
