Merck & Co. today said it has launched in the U.S. a biosimilar of Remicade® (infliximab), the blockbuster immune-mediated inflammatory disorders treatment it markets outside the U.S., including Europe, while partner Janssen Biotech markets the drug stateside.

The biosimilar, to be marketed as Renflexis™ (infliximab-abda), is the first to reach the U.S. market through a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis, a joint venture of Samsung and Biogen.

Renflexis will be introduced in the U.S. at a list price of $753.39—which according to Merck is a 35% discount to the current list price of Remicade. The list price reflects wholesaler acquisition, which does not include discounts that may be paid on the products.

“Merck believes that biosimilars have the potential to help increase access to these important medicines while also providing savings for the health care system,” Dora Bibila, general manager, Merck Biosimilars, said in a statement. “Merck looks forward to launching Renflexis in the United States to help meet the needs of patients, physicians, and payers.”

Merck said it will make available at launch resources that include comprehensive education and support services for health care professionals, patients, and their caregivers—including biosimilars education, disease education, and reimbursement and access support.

Renflexis is a tumor necrosis factor (TNF) blocker that became the fifth biosimilar to win FDA approval on April 21. That approval included all eligible indications as Remicade:

  • Moderately to severely active Crohn's disease in adults and children who have had an inadequate response to conventional therapy;
  • Moderately to severely active ulcerative colitis in adults who have had an inadequate response to conventional therapy;
  • Moderately to severely active rheumatoid arthritis, in combination with methotrexate;
  • Active ankylosing spondylitis;
  • Active arthritis, including psoriatic arthritis;
  • Chronic severe (i.e., extensive and/or disabling) plaque psoriasis in adults who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

FDA approval was based on Samsung Bioepis submitting analytical, nonclinical, and clinical pharmacokinetic, safety, and effectiveness data that convinced the agency that Renflexis was highly similar to its reference product Remicade in safety, purity, and potency.

Declining Remicade Sales

Last year Remicade generated $7.829 billion in sales– $6.561 billion by Janssen parent J&J and $1.268 billion by Merck—giving the drug a no. 5 ranking on GEN’s List of Top 15 Best-Selling Drugs of 2016. However, Remicade’s sales last year were 10.6% below 2015 sales, reflecting the loss of exclusivity in the U.S. and Europe and launch of competing biosimilars.

Renflexis is the second biosimilar to Remicade approved by the FDA. The first was Inflectra® (infliximab-dyyb), a biosimilar marketed by Pfizer’s Hospira subsidiary and Celltrion, and launched in the U.S. in December 2016 after it was the second biosimilar to win FDA approval.

In Europe, where approvals of biosimilars have progressed further than in the U.S., Hospira is one of three companies marketing biosimilar versions of Remicade. That product, Inflectra (infliximab), was launched February 16, 2015, followed eight days later by the launch of Celltrion’s biosimilar Remsima® (infliximab), and last year by Samsung Bioepis’ Flixabi® (infliximab).

Renflexis is the first of two Merck-Samsung biosimilars to gain approval this year. The other approval came last week, when Merck won tentative FDA approval for Lusduna™ Nexvue™ (insulin glargine injection), its follow-on biologic basal insulin developed by Merck with partial funding from Samsung Bioepis.

The FDA’s approval of Lusduna is tentative because Sanofi has sued Merck, contending that Lusduna infringes on patents for its marketed diabetes treatment Lantus® (insulin glargine).

Merck and Samsung Bioepis began collaborating on biosimilars in 2013, then expanded their alliance to diabetes treatments the following year.

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