Celltrion, Pfizer win FDA OK for biosimilar of J&J's Remicade

The FDA has approved Celltrion's biosimilar version of Johnson & Johnson's Remicade, cracking open a big market for one of the world's top blockbusters.

This is the second biosimilar approved by the FDA, a pioneer among a new wave of complex copycats that are threatening to grab market share with less expensive alternatives to the branded original. The IV-administered drug will be sold as Inflectra (infliximab-dyyb).

The writing on the marketing wall was evident back in February, when an FDA panel endorsed the drug--to be co-marketed by Pfizer ($PFE)--for a slew of indications, including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, ulcerative colitis and psoriasis. Already approved in Europe, Pfizer stepped into the partnership with its acquisition of Hospira.

The thumbs-up and subsequent regulatory approval came despite J&J's ($JNJ) protests that their clinical data "do not adequately address residual uncertainty regarding use in" inflammatory bowel diseases.

The FDA's expert advisers, though, felt that it would have been unnecessary to formally test the biosimilar for each and every indication, willing to extrapolate from the results on hand. 

Now it will be up to physicians to see if J&J CEO Alex Gorsky is right in predicting that patients won't suddenly switch to an alternative. J&J has $4.5 billion in annual sales riding on that assumption. And Tuesday evening, the pharma giant quickly braced for a fight.

"It is important to note that the FDA has not approved Celltrion's infliximab-dyyb as being interchangeable with Remicade," said J&J's Chief Biotechnology Officer Jay Siegel in a statement. "For FDA to determine a biosimilar is interchangeable with its reference product, a manufacturer must demonstrate that the biosimilar is expected to produce the same clinical result as the reference product in any given patient. In addition, the manufacturer must demonstrate the risk of alternating or switching between the reference product and biosimilar is no greater than the risk of using the reference product."

Morningstar analyst Damien Conover has already noted that Remsima and another Remicade knockoff could grab half of J&J's U.S. revenue by 2020. Just days ago Samsung Bioepis, a joint venture between the South Korean conglomerate and Biogen ($BIIB), won an endorsement from the EMA for their Remicade knockoff, Flixabi.

The FDA recently did biosimilar makers a solid favor by suggesting new rules that will favor the generics with a drug label very similar to the original. Bernstein's Ronny Gal says that Celltrion/Pfizer will be a direct and early beneficiary.

"Last week, the FDA provided its guidance on labelling of biosimilars, where FDA struck a clear position for the 'generic-like' label, where the biosimilar label is essentially the branded Remicade label with the name of the biosimilar replacing the brand (expect for the indication covered by exclusivity)," Gal noted today. "The Inflectra label has a simple statement at the top, noting 'INFLECTRA (infliximab-dyyb) is biosimilar to REMICADE (infliximab) for the indications listed.' In regard to immunogenicity, Inflectra's label presents Remicade's immunogenicity data (this is, in our view, the clearest statement of position by the FDA in favor of generic-like label)."

Pfizer says it won't lay out a marketing strategy, or a competitive price point, yet.

"We cannot comment on our future development and commercialization strategies for Inflectra at this time," the pharma giant said in response to a query from me. "Each biosimilar molecule has specific drivers that determine market price." 

Novartis ($NVS) was the first developer to gain FDA approval of a biosimilar. The agency approved Zarxio, a biosimilar of Amgen's ($AMGN) Neupogen, late last year as the first in a wave of knockoffs now headed to the U.S. market.

"Biosimilars can provide access to important treatment options for patients who need them," said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. "Patients and the health care community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards."

- here's the release from the FDA

Special Report: The 10 best-selling drugs of 2013 - Remicade