The U.S. is on the brink of seeing the potential impact a competitive biosimilar market could have on drug prices and accessibility.
Merck & Co. Inc., of Kenilworth, N.J., announced last week the immediate launch of Renflexis, the second FDA-approved biosimilar referencing Johnson & Johnson’s (J&J) Remicade (infliximab). Merck, which is commercializing the biosimilar in the U.S. in partnership with South Korea’s Samsung Bioepsis Co. Ltd., set the list price for the tumor necrosis factor (TNF) blocker at $753.39, a 35 percent discount to the current list price of Remicade.
That’s the steepest discount offered for a biosimilar in the U.S. New York-based Pfizer Inc. launched the first Remicade biosimilar – Inflectra, partnered with South Korea’s Celltrion Inc. – at a 15 percent discount in November, reflecting what has been the market norm for a first biosimilar. With the launch of Renflexis, Remicade becomes the first biologic to have two biosimilars on the U.S. market. (See BioWorld Today, Oct. 19, 2016.)
The launch of the follow-on marks yet another first. Approved by the FDA in April, Renflexis is the first biosimilar to benefit from June’s U.S. Supreme Court ruling in Sandoz Inc. v. Amgen Inc., in which the court said biosimilar sponsors don’t have to wait for approval before giving the innovator the required 180-day notice of commercial marketing. Prior to that ruling, biosimilar launches were delayed at least six months following FDA approval. (See BioWorld Today, April 26, 2017, and June 13, 2017.)
Since infliximab is a specialty drug that’s infused in a provider setting, Renflexis will compete as if it were in a brand market rather than a generic market, which generally doesn’t offer all the support and reimbursement services that specialty biologics are expected to provide, Robert Consalvo, a Merck spokesman, told BioWorld.
So along with the discount, Merck will offer Renflexis patients support services and patient assistance programs (PAPs). They’ll have “essentially the same patient support and services that you’d expect for any Merck product,” Consalvo said. Merck also plans to roll out a Renflexis website to give patients one-stop access to information about the drug, related services and PAPs.
Bringing together the steeper discount and the support associated with biologics, the launch of Renflexis will give the U.S. an opportunity to see what the biosimilar experience looks like vs. the generic experience, Consalvo added.
The immediate launch may have caught J&J, of New Brunswick, N.J., a bit off guard. During the company’s second-quarter earnings call in July, CEO Alex Gorsky said the Renflexis launch wasn’t expected until later this year. Regardless, the presence of a second biosimilar shouldn’t impact Remicade earnings this year as J&J already has annual contracts in place for its blockbuster immunology drug, Gorsky noted.
Although Pfizer’s Inflectra hit the U.S. market last year, J&J hasn’t seen as much impact from the competition as was expected, Gorsky said. Remicade sales were down 14 percent, but Gorsky said most of the erosion was due to price adjustments and some conversion of patients with Crohn’s disease to the company’s Stelara (ustekinumab). He attributed a little more than 5 percent of the decrease to Inflectra; company officials had predicted a 10 percent to 15 percent loss due to the biosimilar.
Meanwhile, the U.S. continues to prepare for biosimilar competition for other blockbuster biologics. Following a positive advisory committee meeting in July, Thousand Oaks, Calif.-based Amgen is awaiting an FDA approval decision on its biosimilar referencing Avastin (bevacizumab, Roche Holding AG). (See BioWorld, July 14, 2017.)
Amgen’s ABP-215, partnered with Allergan plc, of Dublin, could be the first Avastin biosimilar approved in the U.S., but others are moving through the pipeline. For instance, Pfizer reported last week that its bevacizumab biosimilar candidate met its primary objective in a comparative, confirmatory safety and efficacy study in first-line treatment for advanced non-squamous non-small-cell lung cancer. In the trial, PF-06439535 demonstrated equivalence to Avastin in the primary endpoint of objective response rate. Both drugs were administered in combination with carboplatin/paclitaxel.
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