Inflectra

Biosimilar Drug Profile: Inflectra was the first FDA-approved biosimilar version of infliximab (reference product, Remicade^®) manufactured by Janssen Pharmaceuticals.

Originally designated CT-P13, Celltrion submitted a biologic license application for approval via the 351(k) biosimilar pathway in August 2014. The Food and Drug Administration (FDA) approved the biosimilar in April 2016, and it was marketed by the end of the year. The European Medicines Agency approved the product in 2015 and it has been marketed in the EU as Remsima. Of note, Celltrion and Pfizer decided to launch Inflectra “at risk,” meaning that before its patent litigation had been completed.

Celltrion is also testing an investigational subcutaneous formulation of Inflectra. This formulation was approved in the EU in November 2019. If a BLA is completed for the US market, it will likely not be filed as a 351(k) biosimilar but a 351(a) biologic.

Celltrion was founded in 2002 in Incheon, South Korea. Its first biosimilar product was approved in 2013 by the European Medicines Agency. Inflectra was first approved in the US in 2016. Another biosimilar product (Truxima) was approved in November 2018, and Celltrion has several other biosimilar products in development. Inflectra is the only product resulting from the partnership between Celltrion and Pfizer; two other biosimilars were also involved, but the rights to CT-P6 and CT-P10 were returned to Celltrion after Pfizer’s acquisition of Hospira. Celltrion also partnered with Teva for marketing activities in 2016. This partnership involves Truxima and Herzuma (which is also approved in the US).

In addition, Celltrion’s pipeline includes several products at various stages of development, including adalimumab, bevacizumab, cetuximab, etanercept, palivizumab, and a subcutaneous formulation of Inflectra.

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 9, 2019) The FDA announced approval of Amgen’s infliximab biosimilar Avasola. Avasola will be the third infliximab biosimilar agent to be marketed.

(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.

(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.

(February 2, 2018) According to an article posted on the Market Realist website, Pfizer’s US and global biosimilars revenues are growing, but its sales of Inflectra remains stunted.

(January 25, 2018) The US Court of Appeals handed Pfizer a big victory in its gamble to bring its biosimilar version of Remicade® to the market before the completion of patent litigation.

(December 18, 2017) On December 14, Pfizer got an early Christmas present, the approval by the Food and Drug Administration (FDA) of the second infliximab biosimilar in which it has a stake.

(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…

(September 20, 2017) In late May, Merck was named in a UK lawsuit by Pfizer, which has been trying to expand its market for Inflectra^®. Merck, which markets Remicade^® (infliximab) in the EU, was accused of anticompetitive practices.

(August 4, 2017) Pfizer announced some disappointing results for the second quarter in its quest to advance a foothold in the biosimilar market. The second-quarter results hinted at more difficulties to come for the Inflectra^® brand, with the most recent launch of Merck’s Renflexis^®.

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