Renflexis

Summary: Renflexis (initially designated SB2) is a biosimilar version of infliximab (reference product, Remicade, Jannsen) manufactured by Samsung Bioepis/Merck. It is marketed in the US by Merck. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in May 2016. The biologic was approved by the FDA in April 2017 and entered the market in July 2017 at a discount of 35% off the list price of Remicade.

Samsung Bioepis Co., Ltd. develops and produces biopharmaceutical and biosimilar products. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen that operates as a subsidiary of Samsung Biologics Co., Ltd.  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. The company was incorporated in 2012 and is based in Incheon, South Korea.

As of Q4 2019, Inflectra (Celltrion/Pfizer) and Renflexis were the two biosimilars approved by the FDA that have been available for prescription. Pfizer’s separate approval of Ixifi by the FDA was a result of its acquisition of Hospira. To avoid competition with Inflectra, for which it has marketing responsibilities in the US, Ixifi will not be launched in this country and sold exclusively overseas.

Renflexis was discounted 35% off the list price of Remicade at launch. This was greater than the 15% discount Inflectra was priced off the list price of Remicade at launch. Janssen Biotech has increased its rebates to gain the upper hand on net costs. Janssen is also the subject of a lawsuit by Pfizer that claims it is using exclusionary contracts practices to block coverage of the biosimilars. At present, Remicade revenues have been falling; this is more a result of lower net prices than of loss of marketshare.

Nichi-Iko Pharmaceuticals (and its US subsidiary Sargent Pharmaceuticals) is slated to complete a phase 3 trial in the US that may prove interchangeability with reference infliximab. Amgen is awaiting approval of its own biosimilar inflximab, after withdrawing its EMA application (due to low revenue potential). Celltrion received EU approval of a subcutaneous form of infliximab, which though it may not be considered a biosimilar, can have a disruptive effect on the infliximab biosimilar marketplace.

Infliximab Biosimilar(s) in Development

(February 7, 2020) On February 5, Merck announced that it will create a new spinoff that will include its biosimilar business with Samsung Bioepis as well as its legacy pharmaceuticals (e.g., Zetia^®, Vytorin^®, and other widely diversified brands).

(December 6, 2020) On December 6, 2019, the US Food and Drug Administration (FDA) gave Amgen its approval to market the fourth biosimilar infliximab medicine.

(November 26, 2019) Celltrion received approval today in the European Union (EU) for its subcutaneous (SC or SubQ) form of infliximab (Remsima^®, marketed as Inflectra^® in the US) for treating rheumatoid arthritis. Currently, infliximab is available only as an office-based infusion.

(May 30, 2019) Effective July 1, 2019, approximately 22.5 million commercial and 6 million Medicaid UHC members will not be able to access these biosimilars without trying the reference agents first (virtually eliminating biosimilar use).

(December 17, 2018) ABP 710 was the subject of a phase 3 trial in patients with moderate-to-severe rheumatoid arthritis.

(October 18, 2018)  UnitedHealthcare has become the first to publicly implement step therapy policies for part B drugs. However, biosimilar step therapy is not the typical utilization management tool that industry executives are used to seeing.

(October 8, 2018) Merck has inked an exclusive contract to supply Renflexis with the US Department of Veterans Affairs.

(July 18, 2018) Exclusive contracting for preferred drugs is an old tool from the pharmaceutical industry’s lifecycle management arsenal. Let’s not act like J&J’s actions on infliximab are a shocking new development.

(June 21, 2018) Everyone with an opinion believes that biosimilar drug use will save the health system considerable money. Calculations for biosimilar savings have been hampered by several factors. For example, previous high estimates have not been based on real-life scenarios.

(May 14, 2018) When President Trump announced the broad strokes of his drug price reform initiative, some of these measures seemed on target to benefit the biosimilars industry. However long awaited, makers of originator biologics seemed not to be worried about its implications. The President may not be able to effect much change, without causing unintended adverse consequences

(May 9, 2018) Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used  to encourage use of the originator product.

(March 2, 2018) The second quarter is expected to be rife with news regarding Food and Drug Administration approval decisions on a biosimilar for rituximab and two pending applications for trastuzumab. Although biosimilars have not generated much news of importance lately, we wrap up the week with some items of interest.

(November 30, 2017) When asked about potential cost savings with the infliximab biosimilar, nearly one-quarter of health system respondents did not believe that it represented a cost savings opportunity for their organization, according to a newly published survey in the Journal of Managed Care and Specialty Pharmacy.

(November 14, 2017) According to a Reuters report, Janssen Biotech withdrew its patent lawsuit against Samsung Bioepis on November 10. The suit alleged infringement in the manufacture of Samsung’s infliximab biosimilar. The action, which was filed in U.S. District Court of New Jersey, means that Merck and Samsung, which launched Renflexis™ in July, is no longer at risk…

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