Biosimilar Drug Profile: Eticovo (SB4) is a biosimilar version of entanercept (reference product, Enbrel by Amgen) manufactured by Samsung Bioepis. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in September 2015 with approval given April 25, 2019. The biosimilar is currently not marketed in the US due to patent litigation; Amgen believes its patents won’t expire until 2029. Eticovo was approved by the European Medicines Agency for launch in the EU January 2016 (marketed as Benepali) . Sales in 2018 in Europe were reported by Samsung to be $485 million.
About the Manufacturer
Based in Incheon, South Korea, Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. It was first incorporated in 2012 . In early 2013 Samsung Bioepsis and Merck entered into a business agreement to develop and commercialize biosimilars. Samsung Bioepis Co., Ltd. also entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited in August 2017. Besides Eticovo, Samsung Bioepis is an active player in the biosimilar market, with three other products approved in the US—Renflexis (infliximab), Ontruzant (trastuzumab), and Lusduna (insulin glargine, a transitional biosimilar product)—and several in the pipeline for the US market, including adalimumab (a Humira biosimilar), bevacizumab (an Avastin biosimilar), ranibizumab (a Lucentis biosimilar), and eculizumab (a Soliris biosimilar).
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Eticovo is the second etanercept biosimilar to be approved by the FDA. The product has not yet entered the marketplace.
APPROVED BIOSIMILARS
Company name |
Product name |
Status |
Sandoz |
Erelzi (etanercept-szzs) |
Approved August 31, 2016 for all of Enbrel’s indications; not yet marketed |
BIOSIMILARS IN DEVELOPMENT
Company name |
Product name |
Stage of development |
Coherus BioSciences |
CHS-0214 |
Positive phase III results reported in June 2016, no longer mentioned in Coherus’ pipeline |
Lupin/Yoshida/Mylan, India/Japan/US |
YLB113 |
Global phase III trials in rheumatoid arthritis completed in February 2018. Approved in Japan in April 2019. Submitted for approval by EMA in May 2018. US filing anticipated 2020 |
Celltrion, South Korea |
CT-P05 |
No clinical trials underway; current status not disclosed |
Sandoz Loses Patent Litigation Against Amgen's Enbrel
(August 9, 2019) A US District Court judge sided with Amgen in its patent case against Sandoz. This could mean that Amgen’s key Enbrel patents are protected until 2029.
Second Etanercept Biosimilar Receives FDA Approval
(May 2, 2019) Samsung Bioepis scored another biosimilar approval in the US, as the Food and Drug Administration gave its nod to etanercept-ykro on April 25, 2019. Formerly known as SB4, Samsung Bioepis dubbed this agent Eticovo™. It is the second Enbrel® biosimilar to to receive US approval.
Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars
(August 10, 2018) Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.
Let's not Knock Innovation, but Biosimilars Exist for the Sake of Competition
(June 29, 2018) What is the real benefit of biosimilars? Does biosimilar development detract from efforts to produce innovative medicines? Is the main societal benefit biosimilar cost savings?
Analyzing FDA Chief Gottlieb's Remarks--Part 2: FDA and Marketing Exclusivity
(April 2, 2018) Food and Drug Administration Chief Scott Gottlieb, MD, received a great deal of coverage for his recent remarks on providing better access to biosimilars. He seems intent on finding solutions to the underlying problems in delayed biosimilar launches..
Sandoz receives EU approval for Erelzi (biosimilar etanercept)
Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed
(January 27, 2017) Sandoz’s Erelzi™, which was approved by the Food and Drug Administration on August 30, 2016, has been caught in the patent litigation web. The originator drug, Amgen’s Enbrel® was first approved in 1998.
Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada
(September 12, 2016) Samsung Bioepis’ etanercept biosimilar SB4 approved for use in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis.
First New Enbrel Biosimilar Approved by FDA
(August 31, 2016) Sandoz received approval by the Food and Drug Administration to market its biosimilar version of Enbrel® on Tuesday, August 30th. The FDA is calling this agent etanercept-szzs. It is the first biosimilar for etanercept approved for use in the US.forts.
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